TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER m: FOOD, DRUGS AND COSMETICS
PART 775 GRADE A PASTEURIZED MILK AND MILK PRODUCTS
SECTION 775.55 RAW MILK PERMIT
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 email@example.com 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)