01-001-329 Me. Code R. § VI

Current through 2024-52, December 25, 2024
Section 001-329-VI - SANITATION REQUIREMENTS FOR PRODUCTION AND PROCESSING
A. SANITATION REQUIREMENTS FOR DAIRY FARMS - Guidelines for determining compliance with these requirements may be found in the PMO.
1. ABNORMAL MILK - Lactating animals which show evidence of the secretion of milk with abnormalities in one or more quarters, based upon bacteriological, chemical or physical examination, must be milked last or with separate equipment and the milk must be discarded. Lactating animals producing contaminated milk, that is lactating animals which have be entreated with, or have consumed chemical, medicinal or radioactive agents which are capable of being secreted in the milk and which, in the judgment of the Department, may be deleterious to human health, must be milked last or with separate equipment and the milk disposed of as the Department may direct. For applicability to Automatic Milking Installations (AMI) refer to the PMO.
2. MILKING BARN, STABLE OR PARLOR--CONSTRUCTION - A milking barn, stable or parlor must be provided on all dairy farms in which the milking herd must be housed during times of milking operations. (For applicability to AMIs, refer to the PMO). The area used for milking purposes must:
(a) Have floors constructed of concrete or equally impervious materials;
(b) Have walls and ceilings which are constructed of smooth material, be in good repair, dust tight, and be painted or finished in an approved manner;
(c) Have separate stalls or pens for horses, calves, bulls, and any other livestock which are large enough to accommodate all animals without overcrowding;
(d) Be provided with natural and/or artificial light, well distributed, for day and/or night milking;
(e) Provide sufficient air space and air circulation to prevent condensation and excessive odors;
(f) Properly prepared plans for milking equipment installation in all milking facilities, milk plants, receiving stations and transfer stations regulated under this rule which are hereinafter constructed may be submitted to the Department. Equipment standards set forth in "3 -A Accepted Practices for the Design, Fabrication and Installation of Milk Handling Equipment" may be used as a guideline;
(g) Use of emergency portable equipment will be reviewed by the Department on a case by case basis; and
(h) Building construction must prevent contamination of feed area by wild birds.
3. MILKING BARN, STABLE OR PARLOR--CLEANLINESS - The interior must be kept clean. Floors, walls, ceilings, windows, pipelines and equipment must be free of filth and/or litter and must be clean. Swine and fowl must be kept out of the milking area. Area must be free of rodents.

Feed must be stored in such a manner that will not increase the dust content of the air or interfere with the cleaning of the floor.

Surcingles, milk stools and devices to prevent kicking and other equipment associated with dairy animal care must be kept clean and stored above the floor.

4. COWYARD - The cowyard must be graded to drain and must have no standing pools of water or accumulations of organic wastes. Animal droppings and soiled bedding must be removed, or clean bedding must be added to housing areas where animals frequently lie down and at sufficiently frequent intervals to prevent the soiling of the lactating animal's udder and flanks. Cooling ponds may be allowed provided they are constructed and maintained in a manner that does not result in the visible soiling of flanks, udders, bellies and tails of lactating animals exiting the pond. Waste feed must not be allowed to accumulate. Packs that are used for animal bedding must be properly drained and must provide a reasonably firm footing. Swine must be kept out of the cowyard.

Nutrient Management Plans are required unless exempted by Maine law or Department Nutrient Management Rules, Chapter 565 for a person who owns or operates a farm if it meets one or more of the following criteria:

(a) The farm confines and feeds 50 or more animal units at any one time;
(b) The farm utilizes more than 100 tons of manure per year not generated on that farm;
(c) The farm is the subject of a verified complaint of improper manure handling;
(d) The farm stores or utilizes regulated residuals.

Nutrient Management Plans must be implemented in accordance with 7 M.R.S.A. Chapter 747, Nutrient Management Act.

5. MILKHOUSE--CONSTRUCTION AND FACILITIES - A milkhouse or room of sufficient size must be provided, in which the cooling, handling and storing of milk and the washing, sanitizing and storing of milk containers and utensils must be conducted except as provided for in item 12 of this section.
(a) The milkhouse must be provided with a smooth floor constructed of concrete or equally impervious material, graded to drain and maintained in good repair. Liquid waste must be disposed of in a sanitary manner. Floor drains must be accessible and must be trapped if connected to a sanitary sewer system.
(b) The walls and ceilings must be constructed of smooth material, be in good repair, dust tight, and be painted or finished in an approved manner.
(c) The milkhouse must have adequate natural and/or artificial light and be well ventilated.
(d) The milkhouse must be used for no other purpose than milkhouse operations. There must be no direct opening into any barn, stable, parlor or into a room used for domestic purposes. Provided, that a direct opening between the milkhouse and milking barn, stable or parlor is permitted when a tight-fitting, self-closing, solid door(s) hinged to be single or double acting is provided. Screened vents in the wall between the milkhouse and a breezeway, which separates the milkhouse from the milking parlor, are permitted, provided animals are not housed within the milking facility.
(e) Water under pressure must be piped into the milkhouse.
(f) The milkhouse must be equipped with a two-compartment wash vat and adequate hot water heating facilities.
(g) A transportation tank may be used for the cooling and/or storage of milk on the dairy farm. Such tank must be provided with a suitable shelter for the receipt of milk. Such shelter must be adjacent to, but not a part of, the milkhouse and must comply with the requirements of the milkhouse with respect to construction items, light, drainage, insect and rodent control and general maintenance. In addition, the following minimum criteria must be met:
1. An accurate, accessible temperature-recording device must be installed in the milk line downstream from an effective cooling device, which cools the milk to 7°C (45°F) or less. Electronic records that comply with the applicable provisions of the PMO, with or without hard copy, may be used in place of temperature-recording records. An indicating thermometer must be installed as close as possible to the recording device for verification of recording temperatures. This indicating thermometer must comply with all applicable requirements in the PMO. This thermometer must be used to check the temperature-recording device during the regulatory inspection and the results recorded on the recording record or into the electronic data collection, storage and reporting system.
2. Temperature-recording charts must be maintained on the premises for a period of a minimum of six (6) months and be available for review by the Department. Except that, the electronic storage of required temperature records, with or without hard copy, may be acceptable, provided the computer and computer generated temperature records are readily available for review by the Department.
3. The milk must be sampled at the direction of the Department in a manner so as to preclude contaminating the milk tank truck or sample, by a permitted milk sample collector.
4. The milk tank truck must be effectively agitated in order to collect a representative sample.
(h) When the Department determines conditions exist whereby the direct loading of a milk tank truck (through by-passing the use of a farm bulk milk tank(s) and/or silo(s)) can be adequately protected and sampled without contamination, a shelter need not be provided if the following minimum criteria are met:
1. The milk hose connection is accessible to, and made from within, the milkhouse. The milk hose connection to the milk tank truck is completely protected from the outside environment at all times. Provided, based on Department acceptance, the direct loading of milk from the milkhouse to the milk tank truck may be conducted through a properly designed hose port that adequately protects the milkhouse opening or by stubbing the milk transfer and associated CIP cleaned lines outside the milkhouse wall in accordance with the ADMINISTRATIVE PROCEDURES in the PMO.
2. To assure continued protection of the milk, the milk tank truck manhole must be sealed after the truck has been cleaned and sanitized.
3. The milk tank truck must be washed and sanitized at the permitted milk plant, receiving station, or transfer station receiving the milk, or at a permitted milk tank truck cleaning facility.
4. An accurate, accessible temperature-recording device must be installed in the milk line downstream from an effective cooling device, which cools the milk to 7ºC (45ºF) or less. Electronic records that comply with the applicable provisions of the PMO, with or without hard copy, may be used in place of temperature-recording records. An indicating thermometer must be installed as close as possible to the recording device for verification of recording temperatures. This indicating thermometer must comply with all applicable requirements in the PMO. This thermometer must be used to check the temperature-recording device during the regulatory inspection and the results recorded on the recording record or into the electronic data collection, storage and reporting system.
5. Temperature-recording records must be maintained on the premises for a period of a minimum of six (6) months and be available for review by the Department. Except that, the electronic storage of required temperature records, with or without hard copy, may be acceptable, provided the computer and computer generated temperature records are readily available for review by the Department.
6. The milk must be sampled at the direction of the Department, in a manner so as to preclude contaminating the milk tank truck or sample, by a permitted milk sample collector. The milk in the milk tank truck must be effectively agitated in order to collect a representative sample.
7. The milk tank truck must be parked on a self-draining concrete or equally impervious surface during filling and storage.
8. When direct loading of a milk tank truck using either a hose port, as addressed above, or stubbing the milk transfer and associated CIP cleaned lines outside the milkhouse wall in accordance with, ADMINISTRATIVE PROCEDURES of the PMO, overhead protection of the milk hose connection to the milk tank truck must be provided.
(i) The milkroom must be provided with a hoseport conveniently located for use by milk haulers when applicable. The hoseport must be constructed and maintained as to prevent insect and rodent entry.
6. MILKHOUSE CLEANLINESS-The floors, walls, ceiling, windows, tables, shelves, cabinets, wash vats, non-product contact surfaces of milk containers, utensils and equipment and other milkhouse equipment must be clean. Only articles directly related to milkhouse activities may be permitted in the milkhouse. The milkhouse must be free of trash, animals and fowl.
7. TOILET-Every dairy farm must be provided with one (1) or more toilets, conveniently located, properly constructed, operated and maintained in a sanitary manner. The waste must be inaccessible to flies and must not pollute the surface or contaminate any water supply. Tight fitting, self-closing, solid door must be provided to separate the toilet room from the milkhouse.
8. WATER SUPPLY-Water for milkhouse and milking operations must be from a supply properly located, protected and operated and must be easily accessible, adequate and of a safe, sanitary quality.
9. UTENSILS AND EQUIPMENT-CONSTRUCTION - All multi-use containers, equipment and utensils used in the handling, storage or transportation of milk must be made of smooth, nonabsorbent, corrosion-resistant, nontoxic materials, and must be so constructed as to be easily cleaned. All containers, utensils and equipment must be in good repair. Multiple-use woven material must not be used for straining milk. All single-serve articles must have been manufactured, packaged, transported and handled in a sanitary manner and must comply with the applicable requirements of (C)(11) of the following section. Articles intended for single-service use must not be reused. Farm holding/cooling tanks, welded sanitary piping and transportation tanks must comply with the applicable requirements of (C)(10) and (C)(11) of the following section.
10. UTENSILS AND EQUIPMENT-CLEANING - The product-contact surfaces of all multi-use containers, equipment and utensils used in the handling, storage or transportation of milk must be cleaned after each usage.
11. UTENSILS AND EQUIPMENT - SANITIZATION - The product-contact surfaces of all multi-use containers, equipment and utensils used in the handling, storage or transportation of milk must be sanitized before each usage.
12. UTENSILS AND EQUIPMENT-STORAGE - All containers, utensils and equipment used in the handling, storage or transportation of milk, unless stored in sanitizing solutions, must be stored to assure complete drainage and must be protected from contamination prior to use. Pipeline milking equipment such as milker claws, inflations, weigh jars, meters, milk hoses, milk receivers, tubular coolers, plate coolers and milk pumps which are designed for CIP cleaning and other equipment, as accepted by FDA which meets these criteria, may be stored in the milking barn or parlor, provided this equipment is designed, installed and operated to protect the product and solution-contact surfaces from contamination at all times. Single service articles (filters) are to be stored free of contamination. In the case of a milking parlor that opens directly into an enclosed housing area, through a covered holding area, the holding area may be seasonally enclosed when:
a. There are no manure pit openings in the parlor, holding area or in the housing area close enough to affect the milking parlor.
b. The cattle holding and housing areas are maintained in good repair and reasonably clean.
c. With respect to dust, odors, rodents and insects, the entire area meets milking parlor standards and the parlor is free of evidence of birds.
13. MILKING-FLANKS, UDDERS AND TEATS - Milking must be done in the milking barn, stable or parlor except as provided by special permit. The flanks, udders, bellies and tails of all milking lactating animals must be free from visible dirt. All brushing must be completed prior to milking. The udders and teats of all lactating animals must be clean and dry before milking. Teats must be treated with a sanitizing solution just prior to the time of milking and must be dry before milking. Wet hand milking is prohibited.
14. PROTECTION FROM CONTAMINATION - Milking and milkhouse operations, equipment and facilities must be located and conducted to prevent any contamination of milk, equipment, containers and utensils. No milk shall be strained, poured, transferred or stored unless it is properly protected from contamination.

After sanitization, all containers, utensils and equipment must be handled in such a manner as to prevent contamination of any product-contact surface.

Vehicles used to transport milk from the dairy farm to the milk plant, receiving station or transfer station must be constructed and operated to protect their contents from the sun, freezing and contamination. Such vehicles must be kept clean, inside and out, and no substance capable of contaminating the milk shall be transported.

15. DRUG AND CHEMICAL CONTROL - Cleaners and sanitizers must be stored in properly identified, dedicated end-use containers. Animal drugs and drug administration equipment must be stored in such a way that milk, milking equipment, wash vats and hand sinks are not subject to contamination. Animal drugs must be properly labeled and segregated, lactating from non-lactating. Unapproved drugs must not be used. Effective measures must be taken to prevent the contamination of milk, containers, equipment, and utensils by cleaners and sanitizers, drugs and drug administrating equipment.
a. Lactating animals treated with medicinal agents must be handled using one of the following:
b.
1. Identified, i.e. leg bands, chalk marks, etc.;
2. Segregated;
3. Otherwise handled in a manner such as to preclude the adulteration of milk offered for sale.
c. Treatment Records (which may consist of paper and file folders, card files, appointment book type calendars, monthly calendars, chalk boards (temporary records), electronic computer records, etc.) must include the following information:
1. Identity of the animal (s) treated;
2. Date(s) of treatment;
3. Drug(s) or other chemicals administered;
4. Dosage administered;
5. Milk discard time; and 6. Withdrawal time prior to slaughter, even if zero.
d. Maintenance of Records: Producers should maintain all treatment records for a minimum of two (2) years in the event of a need to trace back or follow up on a confirmed milk or meat residue.
e. Treated animal must be quarantined or segregated, or otherwise handled in a manner to preclude the sale of milk or the offering of treated animals for sale for slaughter prior to the end of the prescribed withdrawal time.
f. Farm personnel involved in the treatment of animals must receive instruction and understand proper drug use and methods to avoid the marketing of adulterated milk or meat for human food.
16. PERSONNEL-HAND-WASHING FACILITIES - Adequate hand-washing facilities must be provided, including a lavatory fixture with hot and cold or warm running water, soap or detergent and individual sanitary towels, convenient to the milkhouse, milking barn, stable, parlor and flush toilet.
17. PERSONNEL-CLEANLINESS - Hands must be washed clean and dried with an individual sanitary towel immediately before milking, before performing any milkhouse function and immediately after the interruption of any of these activities. Milkers and milk haulers/samplers must wear clean outer garments while milking or handling milk, milk containers, utensils, or equipment.
18. RAW MILK COOLING - Raw milk for pasteurization must be cooled to 10ºC (50ºF) or less within four (4) hours or less, of the commencement of the first milking, and to 7ºC (45ºF) or less, within two (2) hours after the completion of milking. Provided, that the blend temperature after the first milking and subsequent milkings does not exceed 10ºC (50ºF).
19. INSECT AND RODENT CONTROL - Effective measures must be taken to prevent the contamination of milk, containers, utensils and equipment by insects and rodents and by chemicals used to control vermin. Milkhousess must be free of insects and rodents. Surroundings must be kept neat, clean and free of conditions which might harbor or be conducive to the breeding of insects and rodents. Feed must be stored in such a manner that it will not attract birds, rodents or insects.
20. Requirements for Automatic Milking Installations (AMI) can be found in the PMO.
B. SANITATION REQUIREMENTS FOR PASTEURIZED, ULTRA- PASTEURIZED, ASEPTICALLY PROCESSED MILK AND MILK PRODUCTS - Any person, firm or corporation engaged in pasteurizing, ultra-pasteurizing or aseptically processing milk or milk products must comply with all applicable requirements for these activities as found in the PMO.
C. SANITATION REQUIREMENTS FOR NOT-PASTEURIZED MILK AND MILK PRODUCTS -
1. FLOORS--CONSTRUCTION - The floors of all rooms in which milk or milk products are processed, handled or stored, or in which milk containers, equipment and utensils are washed, must be constructed of concrete or other equally impervious and easily cleanable material; and must be smooth, properly sloped, provided with trapped drains and kept in good repair. Cold-storage rooms used for storing milk and milk products need not be provided with floor drains when the floors are sloped to drain to one or more exits. Storage rooms for storing dry ingredients and/or packaging materials need not be provided with drains and the floors may be constructed of tightly joined wood.
2. WALLS AND CEILINGS--CONSTRUCTION - Walls and ceilings of rooms in which milk or milk products are handled, processed, packaged or stored or in which milk containers, utensils and/or equipment are washed, must have a smooth, washable, light-colored surface and be in good repair.
3. DOORS AND WINDOWS - Effective means must be provided to prevent the access of insects and rodents. All openings to the outside must have solid doors or glass windows which must be closed during dusty weather.
4. LIGHTING AND VENTILATION - All rooms in which milk or milk products are handled, processed or stored or in which milk containers, equipment and/or utensils are washed must be well lighted and well ventilated.
5. TOILET-SEWAGE DISPOSAL FACILITIES - Every milk plant must be provided with toilet facilities conforming to the regulations of the State of Maine Plumbing Code. Toilet rooms must not open directly into any room in which milk and/or milk products are processed. Toilet rooms must be completely enclosed and must have tight-fitting, self-closing doors. Dressing rooms, toilet rooms and fixtures must be kept in a clean condition, in good repair and must be well ventilated and well lighted. Sewage and other liquid wastes must be disposed of in a sanitary manner.
6. WATER SUPPLY - Water for milk plant purposes must be from a supply properly located, protected and operated and must be easily accessible, adequate and of a safe, sanitary quality.
7. HAND-WASHING FACILITIES - Convenient hand-washing facilities must be provided, including hot and cold running water; soap and individual sanitary towels or other approved hand-drying devices. Hand-washing facilities must be kept accessible, in a clean condition, in good repair and must not be utilized for any other use except hand washing.
8. SEPARATE ROOMS -
(a) There must be separate rooms or areas for:
(i) The processing, packaging and cooling of not pasteurized milk and milk products.
(ii) The cleaning of milk cans, bottles and cases.
(b) Rooms or areas in which not pasteurized milk or milk products are handled, processed or stored, or in which milk containers, utensils and equipment are washed or stored, must not open directly into any stable or any place where animals are kept, and must have a self-closing door. All rooms must be of sufficient size for their intended purpose.
9. MILK PLANT CLEANLINESS - All rooms in which milk and milk products are handled, processed or stored and/or in which containers, utensils or equipment are washed or stored, must be kept clean, neat and free of evidence of insects and rodents. Only equipment directly related to the processing operations or to handling of containers, utensils and equipment is permitted in the processing, cooling, packaging and bulk milk storage rooms.
10. CLEANING AND SANITIZING OF CONTAINERS AND EQUIPMENT - The product-contact surfaces of all multi-use containers used in the transportation, processing and storage of not pasteurized milk and milk products must be effectively cleaned and must be sanitized before each use.
11. PROTECTION FROM CONTAMINATION - Milk plant operations, equipment and facilities must be located and operated in a manner to prevent any contamination of milk or milk products, ingredients, equipment, containers and utensils. All milk or milk products or ingredients which have been spilled, overflowed or leaked must be discarded. The processing or handling of products other than milk or milk products in the plant must be performed to preclude the contamination of such milk and milk products. The storage, handling and use of poisonous or toxic materials must be performed to preclude the contamination of milk and milk products, or ingredients of such milk and milk products or the product-contact surfaces of all equipment, containers or utensils.
12. COOLING OF NOT PASTEURIZED MILK - All not pasteurized milk and milk products must be maintained at 7°C (45°F) or less until processed or sold.
13. BOTTLING AND PACKAGING - Bottling and packaging of not pasteurized milk and milk products must be done at the place of processing in a manner approved by the Department.
14. VEHICLES - All vehicles used in the transportation of not pasteurized milk and milk products must be constructed and operated so that the milk and milk products are maintained at 7°C (45°F) or less, and are protected from sun, from freezing and from contamination.
15. CONSTRUCTION AND REPAIR OF CONTAINERS AND EQUIPMENT - All multi-use containers and equipment that milk or milk products come into contact with must be of smooth, impervious, corrosion-resistant, nontoxic material; must be constructed for ease of cleaning; and must be kept in good repair. All single-service containers, closures, gaskets and other articles that milk or milk products come in contact must be nontoxic and must have been manufactured packaged, transported and handled in a sanitary manner. Articles intended for single- service use must not be reused.
16. STORAGE OF CLEANED CONTAINERS AND EQUIPMENT - After cleaning, all multi-use milk or milk products containers, utensils and equipment must be transported and stored to assure complete drainage and must be protected from contamination before use.
17. STORAGE OF SINGLE-SERVICE CONTAINERS, UTENSILS AND MATERIALS - Single-service caps, cap stock, parchment paper, containers, gaskets, liners, bags and other single-service articles for use in contact with milk and milk products must be purchased and stored in sanitary tubes, wrappings or cartons; must be kept therein in a clean, dry place until used; and must be handled in a sanitary manner.
18. PERSONNEL--CLEANLINESS - Hands must be thoroughly washed before commencing milk plant functions and as often as may be required to remove soil and contamination. Employee must thoroughly wash their hands before resuming work after visiting the toilet room. All persons, while engaged in the processing, pasteurization, handling, storage, packaging or transportation of milk, milk products, containers, equipment or utensils must wear clean outer garments. All persons, while engaged in the processing of milk or milk products, must wear adequate hair coverings and must not use tobacco.
19. SURROUNDINGS - Milk plant surroundings must be kept neat, clean and free from conditions which might attract or harbor flies, other insects and rodents or which otherwise constitute a nuisance.
D. SANITATION REQUIREMENT FOR BULK MILK HAULER/SAMPLERS AND MILK TANK TRUCKS -Requirements and guidelines for determining compliance may be found in the PMO.
E. SANITATION REQUIREMENTS FOR SINGLE SERVICE CONTAINER MANUFACTURERS -Requirements and guidelines for determining compliance may be found in the PMO.

01-001 C.M.R. ch. 329, § VI