Section 775.10  Definitions

 

In addition to the definitions contained in Section 1 of the Grade A Pasteurized Milk Ordinance (PMO), the following definitions shall apply:

 

"Act" means the Grade A Pasteurized Milk and Milk Products Act [410 ILCS 635].

 

"Applicant" means a person who formally applies to be a certified pasteurizer sealer or bulk milk hauler/sampler.

 

"Certified pasteurizer sealer" means a person who has satisfactorily completed a course of instruction and has demonstrated the ability to satisfactorily conduct all pasteurization control tests, as required by this Part.  (Section 3(b)(17) of the Act and Section 2.39 of the Illinois Food, Drug and Cosmetic Act)

 

"Change of ownership" means a transaction in which a new or different owner takes possession of a specified entity. 

 

"Change of tenant" means a transaction in which a new or different tenant rents or leases a specified entity such as a dairy farm.

 

"Clarification" means an operational procedure that removes sediment from milk.

 

"Consumer" means a person or group of people, such as a household or those under a distribution agreement, that purchase raw milk from the dairy farm for consumption.

 

"Cultured dairy products" means milk and milk products that have been soured after pasteurization using harmless lactic-acid-producing bacteria, food grade phosphoric acid, lactic acid, citric acid or hydrochloric acid, with or without rennet and/or other safe, suitable milk-clotting enzymes.

 

"Dairy farm" means any place or premises where one or more lactating animals (cows, goats, sheep, water buffalo, or other hoofed mammal) are kept for milking purposes, and from which a part or all of the milk or milk product is provided, sold or offered for sale to a consumer, milk plant, receiving station or transfer station.

 

"Department" means the Illinois Department of Public Health.  (Section 3(b)(7) of the Act)

 

"Director" means the Director of the Illinois Department of Public Health.  (Section 3(b)(8) of the Act)

 

"Distribution agreement" means a herd share or community supported agriculture (CSA) program in which consumers purchase a membership from the dairy farm that entitles them to share the dairy farm's raw milk production, or a buying club in which consumers order raw milk directly from the farm for pick-up by the consumer on the premises of the dairy farm.

 

"Distribution point" means a physical location on the premises of a dairy farm producing raw milk where the raw milk is collected from the various herd sites and distributed to the consumer.

 

"Downstream" means located after the automatic milk flow safety device in a high temperature short time (HTST) flow-diversion device.

 

"Embargo or hold for investigation" means a detention or seizure designed to deny the use of milk or milk products which may be unwholesome or to prohibit the use of equipment which may result in contaminated or unwholesome milk or dairy products.  (Section 3(b)(9) of the Act)

 

"Enforcing agency" means the Illinois Department of Public Health or a unit of local government electing to administer and enforce the Act as provided for in the Act.  (Section 3(b)(12) of the Act)

 

"Field representative" means a person qualified and trained in the sanitary methods of production and handling of milk as set forth in this Part, and generally employed by a processing or manufacturing plant for the purpose of doing quality control work.

 

"Grade A" means that milk and milk products are produced and processed in accordance with the current Grade A Pasteurized Milk Ordinance as adopted by the National Conference on Interstate Milk Shipments and the United States Public Health Service – Food and Drug Administration.  The term Grade A is applicable to "dairy farm", "milk hauler-sampler", "milk plant", "milk product", "receiving station", "transfer station","bulk milk pickup tank", and "certified pasteurizer sealer" whenever used in the Act.  (Section 3(a) of the Act)

 

"Herd share" means a consumer-signed agreement with the owner of the dairy farm that offers partial ownership of one or more animals, stipulates the expected quantity of raw milk to be received, and requires ongoing payment by the consumer to the farmer for boarding the animal, animals or herd and the service of milking for the consumer.

 

"High temperature short time flow-diversion device" or "HTST flow-diversion device" means an automatic milk-flow safety device that controls the flow of milk in relation to the temperature of the milk or heating medium and/or pressure, vacuum, or other auxiliary equipment.

 

"Imminent hazard to the public health" means any hazard to the public health when the evidence is sufficient to show that a product or practice, posing or contributing to a significant threat of danger to health, creates or may create a public health situation that should be corrected immediately to prevent injury and that should not be permitted to continue while a hearing or other formal proceeding is being held.  (Section 3(b)(10) of the Act)

 

"Milk" means the milk of cows or goats and includes skim milk and cream. (Section 3(b)(2) of the Act)

 

"Milkfat and Nonfat Solid Content Standards" means the standards set forth in 21 CFR 131.110.  (See Section 775.20.)

 

"Milk plant" means any place, premise, or establishment where milk or milk products are collected, handled, processed, stored, pasteurized, ultra-pasteurized, aseptically processed and packaged, condensed, dried, or prepared for distribution.  (Section 3(b)(3) of the Act)

 

"Pasteurization" or "pasteurized" or similar terms mean the process of heating every particle of milk or milk products, in properly designed and operated equipment, to one of the temperatures given in the charts in the Pasteurized Milk Ordinance (PMO) (see Section 775.20(a)(1)(A)) and held continuously at or above that temperature for at least the corresponding specified time.

 

"Permit" means a document awarded to a person for compliance with the provisions of and under conditions set forth in the Act and this Part. (Section 3(b)(13) of the Act)

 

"Person" means any individual, group of individuals, association, trust, partnership, corporation, person doing business under an assumed name, the State of Illinois, or any political subdivision or Department thereof, or any other entity.  (Section 3(b)(11) of the Act)

 

"Quality assurance program" means the Milk and Dairy Beef Quality Assurance Program, Boeckman, Steve and Carlson, Keith R., Agri-Education Inc., Stratford, Iowa 50249 or equivalent program as determined by the Department.

 

"Raw milk" means milk that has not been pasteurized.

 

"Raw milk dispenser" means equipment approved by 3-A standards and used to store, cool and provide a mechanism for self-service of bottled raw milk to the consumer.  "Raw milk dispenser" does not mean household refrigerator or commercial refrigerator.

 

"Raw milk permit" means a permit that allows a dairy farm to sell or distribute raw milk, for use or consumption to consumers, only on the premises of the dairy farm where the animal, animals or herd is located.

 

"Receiving station" means any place, premise, or establishment where raw milk is received, collected, handled, stored or cooled and prepared for further transporting.  (Section 3(b)(5) of the Act)

 

"Separation" means an operational procedure that removes butterfat from milk.

 

"Transfer station" means any place, premise, or establishment where milk or milk products are transferred directly from one milk tank truck to another.  (Section 3(b)(6) of the Act)

 

"Violative drug residue" means a drug residue at or above the tolerance and/or safe levels as set forth in 21 CFR 556 and Appendix N of the PMO.

 

(Source:  Amended at 40 Ill. Reg. 2964, effective January 29, 2016)

 

Section 775.20  Incorporated and Referenced Materials

 

a)         The following regulations, guidelines and standards are incorporated in this Part:

 

1)         Federal government guidelines:

 

A)        The Grade A Pasteurized Milk Ordinance (PMO), and Appendices A through R (except Sections 16 and 17) Recommendations of the United States Public Health Service/Food and Drug Administration, 2017 Revision (Publication 229).  U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Milk Safety Branch (HFS-316), 5100 Paint Branch Parkway, College Park MD 20740-3835.  In addition, the jurisdiction name, left blank in Sections 1, 2, 3, 5, and 11 of the PMO, for the purposes of this Part, shall mean the State of Illinois; and the regulatory agency referred to in Section 1 shall mean the Illinois Department of Public Health.  (See Section 775.30(a).)

 

B)        Evaluation of Milk Laboratories (2017 Revision), U.S. Department of Health and Human Services, Public Health Service/Food and Drug Administration, Milk Safety Branch (HFS-316), 5100 Paint Branch Parkway, College Park MD 20740-3835.

 

C)        Methods of Making Sanitation Ratings of Milk Supplies (2017 Revision), U.S. Department of Health and Human Services, Public Health Service/Food and Drug Administration, Milk Safety Branch (HFS-316), 5100 Paint Branch Parkway, College Park MD 20740-3835.

 

D)        Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments (2017 Revision), U.S. Department of Health and Human Services, Public Health Service/Food and Drug Administration, Milk Safety Branch (HFS-316), 5100 Paint Branch Parkway, College Park MD 20740-3835.

 

2)         Private and professional standards:

 

A)        Standard Methods for the Examination of Dairy Products (17^th Edition, 2004, American Public Health Association, 1015 – 18^th Street, N.W., Washington, DC 20036).  (See Section 775.70(b).)

 

B)        Official Methods of Analysis of the Association of Official Analytical Chemists (18^th Edition, 2010, Association of Official Analytical Chemists, P.O. Box 540, Ben Franklin Station, Washington, DC 20044).  (See Section 775.70(b).)

 

C)        3-A Sanitary Standards and Accepted Practices (January 5, 2015) (3-A Standards), 3-A Sanitary Standards, Inc., 6888 Elm Street, Suite 2D, McLean VA 22101 (http://www.3-a.org).

 

3)         Federal regulations:

 

A)        21 CFR 131.110, Milk (2019).  (See Section 775.10, the definition of "milkfat and nonfat solid content standards".)

 

B)        21 CFR 556, Tolerances for Residues or New Animal Drugs in Food (2019).  (See Section 775.10, the definition of "violative drug residue".)

 

C)        40 CFR 180, Tolerances and Exemptions from Tolerances for Pesticide Chemicals in Food (2019).  (See Section 775.140(a)(1).)

 

b)         The following rules and statutes are referenced in this Part:

 

1)         Illinois Plumbing Code (77 Ill. Adm. Code 890), Illinois Department of Public Health.  (See Section 775.30(c)(4).)

 

2)         Practice and Procedure in Administrative Hearings (77 Ill. Adm. Code 100), Illinois Department of Public Health.  (See Section 775.90.)

 

3)         Food Service Sanitation Code (77 Ill. Adm. Code 750).

 

4)         The Veterinary Medicine and Surgery Practice Act of 2004 [225 ILCS 115].

 

5)         Illinois Administrative Procedure Act [5 ILCS 100].

 

6)         Food Handling Regulation Enforcement Act [410 ILCS 625].

 

c)         All incorporations by reference of federal guidelines and regulations and the standards of professional organizations refer to the materials on the date specified and do not include any amendments or editions subsequent to the date specified.

 

d)         All citations to federal regulations in this Part concern the specified regulation in the 2019 Code of Federal Regulations, unless another date is specified.

 

e)         Copies of all incorporated materials are available for inspection and copying by the public at the Department's Central Office, Division of Food, Drugs, and Dairies, 525 West Jefferson Street, Springfield IL 62761.

 

(Source:  Amended at 44 Ill. Reg. 15779, effective September 1, 2020)

 

Section 775.30  Minimum Requirements

 

a)         The production,  transportation, processing, handling, sampling, examination, grading, labeling and sale of all milk and milk products; the inspection of dairy herds, dairy farms and milk plants, receiving and transferring stations, and cleaning and sanitizing facilities; the suspension of permits to milk producers and haulers, shall be regulated in accordance with the provisions of the PMO and Appendices A through R (with the exception of Sections 16 and 17) of the PMO.  (See Section 775.20.)

 

b)         The production, handling, sale, distribution, labeling, sampling and testing requirements and quality standards for raw milk, the inspection of dairy farms, and the suspension, revocation and reinstatement of permits of dairy farms shall be regulated in accordance with Sections 775.55 and 775.60.

 

c)         The production, manufacture, packaging, labeling and sale of all Grade A condensed milk, Grade A dry milk products, Grade A condensed whey and Grade A dry whey, for use in the commercial preparation of Grade A pasteurized milk products; the inspection of condensing plants and/or drying plants; and the suspension of permits to condensing plants and/or drying plants, shall be regulated in accordance with the provisions of the PMO and Appendices A through R (with the exception of Sections 16 and 17 of the PMO).  (See Section 775.20.)

 

d)         In addition to subsections (a), (b) and (c), the following provisions shall apply:

 

1)         In addition to Section 7, item 15p of the PMO:

 

A)        All raw milk piping and equipment shall be completely separated from pasteurized milk and milk product piping and equipment during processing.  No raw milk piping or fittings shall be interchanged with pasteurized milk piping and fittings unless they have been cleaned and sanitized before use.

 

B)        Heat-treated and pasteurized milk or milk products that are not produced at the packaging plant, but that are to be used within a plant for processing pasteurized milk or milk products, shall be re‑pasteurized.

 

C)        Blending of pasteurized milk or milk products may occur downstream from the HTST flow-diversion device only when approved by the Department in accordance with the following specific requirements:

 

i)          All pasteurized milk product lines, raw product lines and cleaning lines within the milk plant shall be labeled so that the lines can be differentiated by visual inspection.  The specific configuration of the lines must be verified by a Department on-site inspection prior to the issuance or renewal of a permit.  In addition, any segments of lines that are or can be removed for cleaning shall be individually labeled.

 

ii)         Cultured dairy products are exempt from this requirement.

 

2)         In addition to complying with Section 6 of the PMO, each approved milk plant shall retain from each processing day at least one time and date stamped sample from each continuous processing of a specific pasteurized fluid milk product as defined in the PMO (see Section 1 of the PMO).  These samples shall be of the pasteurized milk product itself and not of each type of container in which the milk product is packaged.  In addition, the samples shall be retained until two days after the guaranteed sale date in accordance with the cooling requirements of the PMO (see Section 7, Table 1 of the PMO).

 

3)         In addition to Section 7, items 8r and 7p, of the PMO, the Illinois Plumbing Code shall apply.

 

(Source:  Amended at 40 Ill. Reg. 2964, effective January 29, 2016)

 

Section 775.40  Local Government Implementation

 

If a unit of local government with a population of 1,000,000 or more adopts its own ordinance, then the unit of local government must comply with this Part.

 

(Source:  Amended at 27 Ill. Reg. 15979, effective October 1, 2003)

 

Section 775.50  Permits

 

It shall be unlawful for any person to establish, maintain, conduct, or operate a dairy farm, milk plant, receiving station, or transfer station processing milk or milk products, to establish and operate a cleaning and sanitizing facility or milk tank truck, to haul or sample milk, or to act as a certified pasteurizer sealer within this State, or to bring in and distribute from out-of-state milk and milk products without first obtaining a permit from the Department. (Section 5 of the Act)

 

a)         The Department will grant and renew a permit for persons who maintain, conduct, or operate a milk plant, receiving station, transfer station, or cleaning and sanitizing facilities within the State of Illinois upon completion of an inspection that establishes compliance with the Act and this Part and upon payment of the fee required by Section 5.1 of the Act. Milk plants that maintain cleaning and sanitizing facilities on the same site as the plant do not have to obtain a separate permit for those facilities.

 

b)         The Department will grant and renew a permit for persons who bring into and distribute pasteurized milk or milk products from another state that has administrative rules or requirements that provide for clean, sanitary and safe handling and processing of pasteurized milk and milk products to ensure protection equivalent to that provided by this Part upon receipt of an inspection report that establishes compliance with that state's administrative rules or requirements and upon payment of the fee required by Section 5.1 of the Act.

 

c)         A permit will be granted to a milk hauler-sampler when the following conditions are met:

 

1)         An inspection establishes that the milk hauler-sampler's equipment is in compliance with the provisions of the Act and this Part;

 

2)         The milk hauler-sampler has successfully completed an examination administered by the Department; and

 

3)         The milk hauler-sampler has paid the fee required by Section 5.1 of the Act.

 

d)         A renewal permit will be granted to a milk hauler-sampler when an inspection establishes that the milk hauler-sampler's equipment and sampling procedures are in compliance with the provisions of the Act and this Part and upon payment of the fee required by Section 5.1 of the Act.

 

e)         Dairy Farm Permits

 

1)         A dairy farm permit is necessary when a farm does not presently hold a permit, when a change of ownership occurs and only the farm owner's name was on the permit, or when a change of tenant occurs and only the former tenant's name was on the permit.

 

2)         A dairy farm permit will be granted to a dairy farm upon the completion of an inspection that establishes compliance with the Act and this Part. The inspection includes procedures for the establishment of a quality record. The quality record is established by the results of four samples taken at a rate of not more than two per week and on separate days within a three-week period.

 

3)         Beginning July 1, 2016, a dairy farm with a dairy farm permit may sell or offer for sale for human consumption raw milk on the premises of the dairy farm in accordance with Section 775.55.

 

4)         Beginning July 1, 2016, it is unlawful for any person who does not possess a dairy farm permit in accordance with Section 775.50 or a raw milk permit in accordance with Section 775.55 to produce, process, sell, offer for sale or distribute raw milk for human consumption.

 

5)         Beginning July 1, 2016, a dairy farm producing raw milk for consumption only by family members living on the dairy farm shall be exempt from Section 775.55.

 

f)         Certified Pasteurizer Sealer Permits will be issued in accordance with Section 775.115.

 

(Source:  Amended at 40 Ill. Reg. 2964, effective January 29, 2016)

 

Section 775.55  Raw Milk Permit

 

a)         A raw milk permit shall be obtained for a dairy farm to sell or distribute raw milk on the premises of the dairy farm in accordance with Section 775.50(e)(3), (4) and (5) and this Section.  The dairy farm owner shall notify the Department when a change of ownership occurs or when a change of tenant occurs.  Dairy farms selling or distributing raw milk will be listed on the Department website (www.dph.illinois.gov).

 

1)         The Department will inspect a dairy farm for compliance with the Act and this Part prior to issuance of a raw milk permit. Inspections will be in accordance with subsection (e).

 

2)         A dairy farm participating in only raw milk sales or distribution of raw milk shall comply with the quality count requirements and standards in subsection (f) and Section 775.50(e)(2) prior to the issuance of the raw milk permit and at all times.

 

3)         The Department will issue a distribution point permit if there is a distribution point on the premises of the dairy farm where raw milk is being stored for sale or distribution in compliance with the requirements of this Section and in accordance with Section 775.50(e)(4).  The distribution point shall be accessible for inspection every three months in accordance with the PMO and upon the Department's receiving any complaints.  The storage place for raw milk shall be protected from contamination, be kept in a sanitary manner and maintained at a temperature of 41°F or below.

 

b)         Sales or Distribution of Raw Milk Procedures

 

1)         Raw milk shall be sold or distributed only on the premises of the dairy farm, with or without a distribution agreement between the dairy farm and the consumer.  If the transaction is made pursuant to a distribution agreement, the dairy farm shall keep the agreement on file and make the agreement available to the Department upon request. 

 

2)         Raw milk sold on the dairy farm shall not be re-sold or re-distributed.

 

3)         Raw milk shall be offered for sale only within five days after production.

 

4)         Consumers may bring their own containers for their raw milk.  If the farm provides the containers for consumer transport, the containers shall meet the requirements of subsection (e)(2).

 

5)         The dairy farm owner shall have a written procedure for recalling products and notifying consumers in accordance with the Illinois Food, Drug and Cosmetic Act. The dairy farm owner shall maintain a log of each raw milk sale or transaction with consumer name, address, phone number and date of sale for six months from the date of sale.  The recall procedure and raw milk sale or transaction log shall be made available to the Department upon request in response to a foodborne outbreak for the epidemiologic investigation.

 

6)         The dairy farm owner shall report foodborne illness related complaints and consumer product complaints received to the Department at dph.dairy@illinois.gov within 5 days.

 

7)         A dairy farm shall not make milk products, such as, but not limited to, cheese or yogurt, from raw milk for sale to consumers.

 

8)         The dairy farm shall submit to the Department, upon request, a statement of the total gallons of raw milk sold the previous 12 months.

 

c)         Signage and Consumer Advisory

 

1)         A dairy farm that sells or distributes raw milk shall post a placard at the point of sale or distribution that is noticeable to consumers.  The placard shall read: "Warning: Milk that is not pasteurized is sold or distributed here.  This dairy farm is not inspected routinely by the Illinois Department of Public Health. Raw milk may contain pathogens that cause serious illness, especially in children, the elderly, women who are pregnant and persons with weakened immune systems."  The placard shall be written in a legible font, such as Arial, and in black ink.  The size of the letters on the placard shall be no less than 2 inches in height.

 

2)         The dairy farm shall provide each new consumer with Department‑approved consumer awareness information. The Department will also post the information on the Department website.

 

d)         Department-approved Labeling and Receipt Information

 

1)         All labeling requirements (see subsection (d)(2)) shall be affixed to the container unless the container is provided by the consumer.  If the container is provided by the consumer, all labeling requirements shall be given to the consumer on a product receipt.

 

2)         The following shall be provided to the consumer either through container labeling or product receipt:

 

A)        The name, address and permit number of the permit holder and product date.

 

B)        The words "not pasteurized" or "unpasteurized" in addition to "raw" preceding the name of the product;

 

C)        The quantity of contents;

 

D)        The production date and the last date the container may be offered for sale, which shall be within five days after the production date;

 

E)        The type of animal preceding the term "raw milk" for example "cow raw milk" or "goat raw milk";

 

F)         The statement "WARNING: This product has not been pasteurized and, therefore, may contain pathogens that cause serious illness, especially in children, the elderly, women who are pregnant and persons with weakened immune systems."; and

 

G)        Instructions for the consumer to notify the local health department for the area in which the consumer resides of a consumer complaint or suspected foodborne illness or to notify the Department of a complaint of farm sanitary conditions.

 

e)         Inspection Standards for Permitted Dairy Farms

 

1)         Dairy Animal Health and Cleanliness

 

A)        Lactating animals that show evidence of the secretion of milk with abnormalities in one or more udders, based upon bacteriological, chemical or physical examination, shall be milked last or with separate equipment, and the milk shall be discarded (not offered for sale or for human consumption).

 

B)        Clean bedding material shall be provided for all lactating dairy animals.  The bedding material, if used, does not contain more manure than has accumulated since the previous milking.

 

C)        Cow yard and loafing areas adjacent to lactating dairy animal housing shall be graded and drained and to minimize standing pools of water or accumulation of organic waste.  Lactating animal droppings and soiled bedding shall be removed, or clean bedding added, at sufficiently frequent intervals to prevent soiling of the lactating animal's udder and flanks.  Manure packs shall be properly drained and shall provide a reasonably firm footing.

 

D)        Swine and fowl shall be kept out of the milking area and not be housed with lactating dairy animals.

 

2)         Equipment Construction and Storage

 

A)        All multi-use containers, utensils and equipment used in handling, storing or transporting milk shall be made of smooth, nonabsorbent and corrosion-resistant food-grade material. Containers, utensils and equipment shall be in good repair. Multiple-use woven material shall not be used for straining milk. All single-service articles shall have been manufactured, packaged, transported and handled in a sanitary manner. Articles intended for single use shall not be reused.

 

B)        All multiple-use containers, utensils and equipment that are exposed to milk or milk products, or from which liquids may drip, drain or be drawn into milk or milk products, shall be made of smooth, impervious, nonabsorbent, safe materials of the following types:

 

i)          Stainless steel of the American Iron and Steel Institute (AISI) 300 series;

 

ii)         Equally corrosion-resistant non-toxic metal;

 

iii)        Heat-resistant glass; or

 

iv)        Plastic or rubber and rubber-like materials that are relatively inert, resistant to scratching, scoring, decomposition, crazing, chipping and distortion under normal use conditions; that are non-toxic, fat resistant, relatively nonabsorbent, and relatively insoluble; that do not release component chemicals or impart flavor or odor to the product; and that maintain their original properties under repeated use conditions.

 

C)        Milk cans shall have umbrella lids.

 

D)        All containers, utensils and equipment used in handling or storing milk or transporting milk by the consumer, unless stored in sanitizing solution, shall be stored to assure complete drainage and shall be protected from contamination prior to use.  These requirements do not apply to containers furnished by the consumer.

 

E)        Raw milk being transported to a distribution point on the premises of a dairy farm shall be transported in approved single-service containers or containers approved in accordance with Item 12p of the PMO. The containers shall be properly cleaned and shall be protected from contamination in a sanitary manner in accordance with the PMO.  The temperature of the product shall be maintained at 41°F or below.  The containers shall be labeled in accordance with the PMO.

 

F)         A raw milk dispenser used for refrigeration of bottled raw milk on the premises of the dairy farm shall be in compliance with the 3-A standards in accordance with PMO Item 9r and Item 11p. A household refrigerator or commercial refrigerator is an option for refrigeration and is exempt from 3-A standards.  The dairy farm shall notify the Department before purchasing the raw milk dispenser. The raw milk dispenser must be preapproved by the Department before being used in compliance with 3-A standards in accordance with PMO Item 9r and Item 11p. The raw milk dispenser shall be kept clean, shall protect the product from contamination, and shall maintain the raw milk temperature at 41°F or below.

 

3)         Milking Practices

 

A)        The flanks, udders, bellies and tails of all lactating dairy animals shall be free from visible dirt.  The udders and teats of all lactating dairy animals shall be clean and dry before milking.  Teats shall be treated with a sanitizing solution just prior to the time of milking and shall be dry before milking.

 

B)        The product contact surfaces of all multi-use containers, equipment and utensils used in handling or storing milk shall be cleaned after each use.

 

C)        The product contact surfaces of all multi-use containers, equipment and utensils used in handling or storing milk and transporting milk by the consumer shall be sanitized before each use by:

 

i)          Complete immersion in hot water at a temperature of at least 77°C (170°F) for at least five minutes; or exposure to a flow of hot water at a temperature of at least 77°C (170°F), as determined by the use of a calibrated thermometer, at the outlet for at least five minutes; or

 

ii)         Chemical compounds contained in 40 CFR 180.940 shall be used in accordance with label directions for sanitizing milk utensils, containers and equipment.

 

D)        The milking operator shall wash his or her hands and dry the hands on a disposable towel prior to beginning milking.

 

E)        Milk shall be cooled to 45°F or below within four hours after beginning milking.  If milk is not sold or distributed to the consumer within four hours after beginning milking, it shall be immediately cooled to 41°F or below.

 

F)         Wet hand milking is prohibited.

 

4)         Milking Environment

 

A)        Milking shall take place in an area with overhead protection to prevent contamination of the raw milk; walls and floors shall be made of a smooth, easily cleanable material, and the area shall have sufficient lighting to visually inspect flanks, teats and equipment.  This area shall be cleaned prior to milking.  When conditions warrant, the Department may approve a barn without four walls, or a shed-type barn, provided it is kept clean and animals and fowl are prohibited from entering the barn.

 

B)        Milking equipment shall be washed and sanitized using a safe, potable water supply.

 

C)        All milking equipment shall be stored in an enclosed room with smooth and easily cleanable walls, or in a sealed storage vessel that protects the food contact surfaces of the equipment.  The storage room shall be maintained in a clean state.

 

f)         Quality Count Requirements and Standards

 

1)         Quality Counts and Standards shall be performed in a certified laboratory in accordance with Section 775.20(a)(1)(A) and (B), Section 775.100 and Appendix B of the PMO.  The results shall be sent to the Department.

 

2)         The samples shall be collected by a certified sampler in accordance with the Act and this Part.

 

3)         Sampling and testing shall be conducted prior to issuance of a permit in accordance with Section 775.50(e)(2) and at least four times during every six consecutive months.  A permit will not be issued until all of the following standards are met. 

 

A)        Coliform shall be less than or equal to 10 coliforms per milliliter of raw milk.

 

B)        Bacteria count shall be less than 20,000 bacteria per milliliter of raw milk.

 

C)        The milk supply shall not contain any drug residues.

 

D)        The somatic cell count shall be less than or equal to 750,000 cells per milliliter of raw cow milk or 1,000,000 cells per milliliter of raw goat milk.

 

E)        The dairy farm water supply shall be free of coliform bacteria.

 

4)         In response to a foodborne outbreak or when a high risk of infection exists, the Department will require pathogen testing to be performed on the raw milk.

 

5)         For every day of a sale or distribution transaction, one raw milk sample shall be kept a minimum of 14 days.  The sample shall be stored between 32°F and 40°F in a sanitary container, be at least 6 ounces and be labeled with the date of the production.

 

g)         Enforcement of Standards and Quality Counts

 

1)         The Department will issue a warning when two out of the last four coliform, bacteria or somatic cell counts are in violation of the standards established in subsection (f)(3). The raw milk permit will be suspended when three out of the last five coliform, bacteria or somatic cell counts are in violation of the standards.

 

2)         The Department will suspend the permit when drug residues are detected in the raw milk supply.

 

3)         The Department will suspend the permit when coliforms are detected in the water supply.

 

4)         The Department will suspend or revoke the dairy farm permit whenever:

 

A)        the Department has reason to believe that a public hazard exists;

 

B)        the dairy farm has interfered with the Department in performance of its duties; or

 

C)        the dairy farm has violated any of the procedures in subsection (a) or (f)(3); Section 775.60(a), (b), (c), (d) or (e); Section 775.80; Section 775.130; or Section 775.150.

 

h)         Reinstatement of Permit

The Department will reinstate the permit

 

1)         when an inspection of the dairy farm does not reveal violations; and

 

2)         when the dairy farm is in compliance with subsection (f).

 

i)          The Department will conduct an inspection of the dairy farm at any time or in response to a consumer complaint, product complaint, or reported suspected foodborne illness pursuant to Section 775.70.  The inspection may include collection of samples and notification to consumers.  The Department will suspend sales if a confirmation test reveals the presence of a pathogen.

 

j)          The PMO does not apply to this Section.

 

(Source:  Added at 40 Ill. Reg. 2964, effective January 29, 2016)

 

Section 775.60  Suspension of Permits

 

The Department will suspend permits in accordance with the provisions of Sections 3, 5 and 6 of the PMO and the following:

 

a)         All suspensions, except summary suspensions, will be preceded by the notice and opportunity for a hearing in accordance with Section 775.90.

 

b)         All summary suspensions will be based upon violations of the Act, the PMO or this Part that constitute a finding that the public interest, safety or welfare imperatively requires the action in accordance with Section 10-65(d) of the Illinois Administrative Procedure Act.  All summary suspensions will be followed by notice and an opportunity for a hearing in accordance with 775.90 of this Part.

 

c)         If a dairy farm, milk hauler-sampler, receiving and transfering station, cleaning and sanitizing facility or milk plant receives two suspensions in 12 months, an informal conference will be held to discuss corrective measures. If the violations resulting in the most recent suspension are not corrected after this conference, administrative hearing proceedings will be initiated pursuant to Section 775.90 of this Part.

 

d)         When successive inspections pursuant to Section 5 of the PMO disclose violations of the same requirement that directly reflect on the health of the public, such as unclean equipment and improper temperature requirements, the suspension policy in Section 5 shall be enforced.

 

e)         The suspension policies in the PMO may be waived as determined by the inspector's professional judgment, dependent upon the amount of time required for the permit holder to make the necessary corrections, the reasonableness of requiring corrections prior to the next inspection, and the potential for a health hazard created by the violation.

 

(Source:  Amended at 37 Ill. Reg. 7166, effective May 13, 2013)

 

Section 775.70  Inspections and Investigations

 

a)         The Department will inspect and investigate complaints concerning dairy farms, milk plants, cleaning and sanitizing facilities, receiving stations, transfer stations, milk hauler-samplers, or milk tank trucks used to transport milk and milk products under its jurisdiction, for the purpose of determining compliance with the Act and this Part.  (Section 10 of the Act)

 

b)         When conducting inspections pursuant to Section 5 of the PMO, the Department will use the Standard Methods for the Examination of Dairy Products and Official Methods of Analysis of the Association of Official Analytical Chemists. (See Section 775.20.)

 

c)         Written notice of all violations shall be given to the dairy farm, milk plant, cleaning and sanitizing facility, receiving or transfer station, milk hauler-sampler or milk tank truck owner/operator after any inspection or investigation. (Section 10 of the Act)

 

(Source:  Amended at 37 Ill. Reg. 7166, effective May 13, 2013)

 

Section 775.80  Approval of Construction Plans

 

All plans for construction or reconstruction, or for alterations other than those to repair or perform maintenance on existing facilities of a dairy farm's milking facilities, transfer stations, receiving stations, cleaning and sanitizing facilities, and milk plants, shall be submitted to the Department for approval before work is begun. The Department will approve plans that meet the requirements of the Act and this Part within 30 days after submission.

 

(Source:  Amended at 37 Ill. Reg. 7166, effective May 13, 2013)

 

Section 775.90  Administrative Hearings

 

All administrative hearings held pursuant to the Act or this Part shall be conducted in accordance with the Department's Practice and Procedure in Administrative Hearings.

 

(Source:  Amended at 37 Ill. Reg. 7166, effective May 13, 2013)

 

Section 775.100  Milk Hauler-Samplers Examination

 

The milk hauler-samplers examination consists of both a written and practical section. The written section concerns the following topics:   the standards for determining the acceptability of milk, sampling procedures, measurement procedures, care of equipment, collection procedures on the farm and information required on "weight tickets" and "cleaning-sanitizing tags". The practical section concerns the following topics:  the proper design of equipment for complete protection of the product, construction and repair standards which facilitate thorough cleaning, effective bactericidal treatment and sampling procedures. Each applicant who fails to attain a minimum 70% passing score on the examination shall submit a new application. Examinations shall be administered by the Department upon request.

 

(Source:  Amended at 27 Ill. Reg. 15979, effective October 1, 2003)

 

Section 775.110  Milk Tank Trucks

 

a)         A milk tank truck may be used only to transport the following products that are intended for and suitable for human consumption:

 

1)         Milk

 

2)         Raw Milk

 

3)         Milk Products

 

4)         Whey and Whey Products

 

5)         Potable Water

 

6)         Liquid Sweeteners

 

7)         Fruit Juices and Drinks

 

8)         Liquified Chocolate and Cocoa Products

 

9)         Liquid Pasteurized Eggs and Egg Products

 

10)         Vinegar

 

11)         Food Colorings

 

12)         Vegetable Oils

 

b)         A milk tank truck shall be cleaned and sanitized prior to the introduction of the milk or milk products, according to Section 7, items 1p, 2p (climatic and operating conditions), 3p (climatic and operating conditions) 4p, 6p, 7p, 8p, 9p, 10p, 11p, 12p, 14p, 15p, 20p, 22p and Appendix F of the PMO.  (Section 14.1(b) of the Act)

 

c)         The owner of each milk tank truck used to haul milk and other substances shall maintain a log for the truck.  This log shall consist of the following:

 

1)         The date or dates of each trip taken by the milk tank truck;

 

2)         The name of the substance hauled by the milk tank truck;

 

3)         The date the milk tank truck was cleaned and sanitized;

 

4)         The location where the milk tank truck was cleaned and sanitized;

 

5)         Such other information deemed necessary by the Department to enforce the Act.

 

d)         The log for a milk tank truck shall be available upon request. (Section 14.1(e) of the Act)

 

(Source:  Amended at 37 Ill. Reg. 7166, effective May 13, 2013)

 

Section 775.115  Certified Pasteurizer Sealer Program

 

The Department will authorize milk plant personnel to test and temporarily seal pasteurization equipment, provided that the conditions in Item 16p.(D), Pasteurization Records, Equipment Tests and Examinations, 2. Equipment Tests and Examinations, of the Pasteurized Milk Ordinance (PMO) and the provisions of this Section are met.  All milk plants with pasteurization equipment shall have one certified pasteurizer sealer by July 1, 2015.  

 

a)         The applicant shall contact the Department Regional Office responsible for the oversight of the milk plant where the applicant is employed (i.e., the appropriate Regional Office).  The application for a certified pasteurizer sealer permit shall consist of the following: 

 

1)         The name and address of the applicant;

 

2)         The location of the milk plant where the applicant is employed; and

 

3)         The type of pasteurization equipment that the applicant is applying to be certified to test and seal, in accordance with PMO Item 16p.(D).

 

b)         Training, Examination and Evaluation Procedures

 

1)         The certified pasteurizer sealer examination and evaluation shall consist of a training course and both a written examination and practical evaluation of testing and sealing pasteurization equipment as referenced in Appendix I of the PMO. 

 

2)         Training

 

A)        Prior to taking the certified pasteurizer sealer written examination, the applicant shall attend a certified pasteurizer sealer training course approved and conducted by the Department. 

 

B)        The training shall be a minimum of eight hours in length, including an examination.

 

C)        The Department will approve the training course based on the following criteria for course content:

 

i)          Instruction on purpose and methodology for pasteurization equipment testing;

 

ii)         Review of pasteurization and PMO Appendix I;

 

iii)        Overview of requirements for testing of pasteurization equipment;

 

iv)        Evaluation of definitions of processes used in pasteurization and explanation of components and instrumentation;

 

v)         Analysis of flow diagrams and discussion of safe systems operation guidelines and importance; and

 

vi)        Assessment of adjustments of each access point on the pasteurization equipment.

 

3)         Written Examination

 

A)        The written examination shall be administered at the appropriate Regional Office or at a location designated by the Department.

 

B)        The minimum passing score for the written examination shall be 80%.  If the applicant passes the examination, the Department will issue a training and examination certificate enabling the applicant to then complete the practical exam.

 

C)        If the applicant fails the written examination, the Department will send a letter of failure. Once the applicant receives the letter of failure, the applicant shall contact the appropriate Regional Office to schedule to retake the examination. 

 

D)        The applicant shall be allowed to retake the examination twice in a six month time period from the date of the applicant's receipt of the letter of failure.  The applicant shall not be allowed to retake the examination on the same day that the applicant fails the examination.

 

4)         Practical Evaluation

 

A)        The practical evaluation will be administered after the applicant has completed the Department-approved training course and passed the written examination.  The Department will provide a copy of the certified pasteurizer sealer training course certificate and written examination to the appropriate Regional Office, with which the applicant shall schedule the practical evaluation.

 

B)        The practical evaluation will be administered on the pasteurization equipment at the milk plant where the applicant is employed and will be evaluated by the Department.

 

C)        The practical evaluation will take place when the Department performs the quarterly pasteurizer equipment checks on each pasteurization system at the milk plant or plants where the applicant is employed.

 

D)        The applicant shall demonstrate proficiency in all pasteurization control test procedures.

 

E)        If the applicant passes the practical evaluation, the Department will issue a certified pasteurizer sealer permit.

 

F)         If the applicant fails the practical evaluation, the Department will issue a letter of failure.

 

G)        Once the applicant receives the letter of failure, the applicant shall contact the appropriate Regional Office to re-schedule a practical evaluation.  The Department shall present the letter of failure to the appropriate Regional Office sanitarian in order to retake the practical evaluation.

 

H)        The applicant shall be allowed to retake the practical evaluation twice in a six month time period from the date of the applicant's receipt of the letter of failure.

 

I)         If the milk plant where the certified pasteurizer sealer is employed obtains a new pasteurizer, the certified pasteurizer sealer must pass a practical test on that new equipment to be approved to seal.  Upon successful completion of the practical, the new equipment will be added to the certified pasteurizer sealer's permit.

 

J)         The applicant shall be required to take the practical evaluation every 12 months to receive a renewed certified pasteurizer sealer permit.

 

c)         Issuance of a Certified Pasteurizer Sealer Permit

 

1)         Thepermit shall be valid only to the person to whom it is issued and shall not be subject to transfer.

 

2)         The permit shall be issued to an applicant who has attended a minimum eight hour training course, passed the written examination and demonstrated proficiency in all pasteurization control test procedures.

 

3)         The permit will list all of the pasteurization equipment that the applicant was certified to test and reseal.

 

4)         The permit will expire on December 31 of each year. For applicants who receive their permits after September 1, the permit will expire on December 31 of the following year. 

 

5)         The initial permit and subsequent renewal permits will be issued upon completion of an annual practical and payment of a $100 fee.

 

(Source:  Added at 39 Ill. Reg. 420, effective December 19, 2014)

 

Section 775.120  Cleaning and Sanitizing Procedures

 

Milk tank trucks used to haul Grade A milk and milk products must be cleaned and sanitized in accordance with Section 7, items 10r and 11r, or item 12p and Appendix F, of the PMO. A cleaning and sanitizing tag shall be attached to all milk tank trucks used to haul Grade A Milk and Milk Products.  In addition, the tag must reflect the name of the substance hauled in the milk tank truck prior to being cleaned and sanitized.

 

(Source:  Amended at 32 Ill. Reg. 8432, effective May 21, 2008)

 

Section 775.130  Action Levels for Added Water in Milk

 

The presence of added water in raw or pasteurized milk constitutes adulteration.  The violative level for added water in either raw or pasteurized milk is equal to or higher than 3% when converted from a milk cryoscope reading on the Hortvet or Centigrade scale when tested in accordance with the Standard Methods for the Examination of Dairy Products.  After two occurrences of adulterated milk within a six-month period, the plant or producer shall show cause and reason for the addition of water.  After a third occurrence, the Department will institute administrative proceedings to revoke the plant or producer's permit.

 

(Source:  Amended at 37 Ill. Reg. 7166, effective May 13, 2013)

 

Section 775.140  Pesticide, Herbicide and Mycotoxin Residue Control Program (Repealed)

 

(Source:  Repealed at 37 Ill. Reg. 7166, effective May 13, 2013)

 

Section 775.150  Drug Residue Control Program

 

a)         Equipment used to administer drugs and medicines shall not be cleaned in the wash vats and shall be stored so as not to contaminate the milk or milk contact surfaces of equipment.

 

b)         Drugs and medicines shall be stored in such a manner that they cannot contaminate the milk or milk product contact surface of the equipment, containers or utensils.  Such products shall be properly labeled to include:

 

1)         The name and address of the manufacturer or distributor (for O.T.C. medicines and drugs), or veterinary practitioner dispensing the product (for Rx and Extra-Label use medicines and drugs);

 

2)         Directions for use, and prescribed holding times;

 

3)         Cautionary statements, if needed; and

 

4)         Active ingredients in the drug product.

 

c)         Unapproved and/or improperly labeled drugs and medicines shall not be used to treat dairy animals and shall not be stored in the milkhouse, milking barn, stable or parlor.  Drugs and medicines intended for treatment of non-lactating dairy animals shall be segregated from those drugs and medicines used for lactating animals.  (Separate shelves in cabinets, refrigerators, or other storage facilities satisfy this item.)

 

d)         Topical antiseptics, wound dressings (unless intended for direct injection into the teat), vaccines and other biologics, and dosage form vitamins and/or mineral products are exempt from labeling and storage requirements except when it is determined that they are stored in such a manner that they may contaminate the milk or milk product surfaces of containers or utensils.

 

e)         The following describes the Department's Drug residue control program for Grade A raw milk under Section 6 of the PMO.

 

1)         If the analysis of a sample from a bulk milk pickup tanker or milk received directly from the farm bulk tank shows any drug residue at or above the tolerances and/or safe levels of drug residues as established by Appendix N of the PMO, then the  individual sample collected from each producer's milk that was in the bulk milk pickup tanker is tested to determine which producer or producers have created or contributed to the drug residue.

 

2)         When the individual sample testing is complete and the tests indicate a violative drug residue, the producer's or producers' Grade A permit will be summarily suspended.  Another sample will be taken from milk produced after corrections have been made to determine whether this adulteration is continual.  For the third occurrence of a drug residue in any 12 month period the Department shall initiate administrative procedures pursuant to revocation of the producer's permit.

 

3)         If the resample shows no violative drug residue, the suspended Grade A permit will be conditionally reinstated for up to 30 days.  The producer and a licensed veterinarian must complete a quality assurance (QA) program, within the 30 day conditional reinstatement of the Grade A permit.

 

4)         When the field representative has transmitted to the Department a copy of the quality assurance program completion certificate, signed by the producer and a licensed veterinarian, the producer's Grade A permit shall be fully reinstated.

 

f)         The following describes the penalty procedures for the Department's drug residue control program for Grade A raw milk.

 

1)         These procedures shall be followed when individual sample testing for drug residues has been completed, test results indicate a violative drug residue, and the producer's or producers' Grade A permit is summarily suspended in accordance with subsection (e) of this Section.  The producer or producers shall submit to the Department an equivalent penalty to the 96 hour period following the violative shipment for the second and third occurrences in any 12 month period.   The equivalent penalty for the second and third occurrences shall be $4.00 per hundred weight of the milk produced during the 96 hours following the violative shipment.  The penalty shall be paid to the Department by the first buyer of the milk, by the last day of the month immediately following the violation.  Following the third occurrence of a drug residue violation in any 12 month period, the Department shall initiate administrative procedures, pursuant to Section 775.90, to permanently revoke the producer's permit.

 

2)         The producer's Grade A permit will be conditionally reinstated for up to 30 days when a subsequent sample of the producer's milk does not contain a violative drug residue.  The producer and a licensed veterinarian must complete a quality assurance (QA) program within the 30 day conditional reinstatement of the Grade A permit.

 

3)         When the field representative has transmitted to the Department a copy of the quality assurance program completion certificate signed by the producer and a licensed veterinarian, the producer's Grade A permit shall be fully reinstated.

 

g)         All monies collected through the drug residue control program and deposited in the Food and Drug Safety Fund will be dedicated to drug residue prevention efforts, producer education and providing information in the prevention of drug residues.

 

(Source:  Amended at 27 Ill. Reg. 15979, effective October 1, 2003)