Environmental Health

The production and processing of milk and milk products in New Jersey is regulated by the Department of Health, Public Health and Food Protection Program Dairy Project.

State Law: NJRS 24:10-57.

Administrative Rules: N.J.A.C. 8:21-10 this rule adopts the federal Pasteurized Milk Ordinance, and associated documents, as amended and supplemented. The PMO applies to both in-state only and Interstate Milk Shipper listed plants and bulk tank units.

“Fluid Milk Products” include: fluid milk, cultured fluid milk, cream, yogurt, raw milk yogurt, sour cream, eggnog, etc.

“Milk Products” include butter, ice cream, and cheese are regulated as wholesale. Products made from milk or cream, such as puddings, cakes, candies, etc., are not classified as milk or fluid milk products and are regulated by the Wholesale Food Project.

All facilities which collect and distribute milk to milk plants or process or pasteurize fluid milk products must have a milk plant or bulk milk license. All facilities which make ice cream or other frozen desserts, and sell them to other businesses, as well as mobile soft serve vehicles must have a frozen dessert plant license. All facilities which make butter or cheese, and sell to other businesses, must have a wholesale food and cosmetic establishment license. All are annual licenses. Milk and frozen dessert licenses expire on the 30th of June and wholesale food and cosmetic establishment licenses for cheese and butter plants expire on the last day of the month, each year after issuance. Dairy farms that are a member of a licensed bulk tank unit supplying raw milk to fluid milk or milk product plants are not licensed per se, but are subject to the Pasteurized Milk Ordinance (PMO) requirements. Dairy farms that supply raw milk directly to fluid milk plants must be licensed as a single-producer bulk tank unit. Dairy farms that supply raw milk directly to milk product plants must be licensed as a wholesale food and cosmetic establishment, but still must comply with the requirements of the PMO.

All plants must submit floor plans and key processing equipment (pasteurization systems, bottling machines, etc.) specifications to the Dairy Project along with a completed application. Pre-operational inspections or site visits should be conducted just prior to the commencement of operations. The earlier we get involved the better.

The sale of raw fluid milk products and raw milk products, except for properly raw aged cheeses, to the ultimate consumer is prohibited. N.J.S.A. 24:10-57.17 states, “No person shall sell, offer for sale, or distribute to the ultimate consumer any milk or cream that is not pasteurized.” and N.J.S.A. 24:10-57.18 states, “No milk products nor fluid milk products shall be manufactured, shipped, transported, or imported for use or sale within this State unless the milk and fluid milk products used in the manufacture of such food products are pasteurized before or during manufacture into milk products or fluid milk products, provided, however, that this shall not apply to cheese which has been kept for at least 60 days after manufacture at a temperature no lower than 35 degrees Fahrenheit.” Raw milk, improperly pasteurized milk and raw milk fresh cheeses have been implicated in foodborne illness outbreaks of Salmonella, Campylobacter, Listeria, E. coli 0157:H7, and Brucellosis in recent years. Pathogenic bacteria such as Brucellosis, Campylobacter, Salmonella and Tuberculosis can be shed in the milk of apparently healthy animals. Listeria monocytogenes is the leading cause of death from a foodborne pathogen.

Milking Parlor or Barn: Floors and milking stands, if used, must be impervious, easily cleanable and in good repair. Floors must be graded to drain. Concrete, metal or tile are acceptable materials for floors and milking stands. Walls and ceilings must be smooth, tight, easily cleanable, light colored and in good repair. Painted wood, plaster, concrete, brick and plastic wallboard are acceptable materials. Adequate lighting (50 foot candles) and ventilation are also required.

Milk Room: Floors must be smooth, impervious, graded to drain and in good repair. Acid and caustic-resistant epoxy-coated floors are best. The milk room drain must have a trap between the milk room and the waste handling facility. This can be below the surface inside or outside of the building. Concrete, metal and tile are acceptable materials. Walls and ceilings must be smooth, tight, easily cleanable, light colored and in good repair. Painted wood, plaster, concrete, brick, sheet metal, tile and plastic wallboard are acceptable materials. Adequate lighting (50 foot candles) and ventilation are required. The milk room cannot open directly into any living quarters. Doors between the milk room and the parlor or barn must be solid, tight, and self closing. Potable water under pressure must be provided to the milk room. Hot water must also be provided to the milk room. A 2 bay wash sink and a hand sink must be provided. All doors must be tight and self-closing. Outer doors may be screened in warm weather provided the doors open outward. Windows may be opened provided they are screened. A bulk milk tank for cooling and storing the milk, unless immediately pasteurized. Milk must be cooled down to 45° or less within 2 hours of the completion of milking and stored at 45° or less. Improper cooling of milk will show in elevated bacteria counts and decreased shelf life. If a bulk tank is used, there must be enough milk to reach the agitator after the first milking in order for the milk to cool properly. Proper cooling is difficult to achieve in a refrigerator unless the milk is put into small containers. The cooling of cultured fluid milk products must be conducted in accordance with Item 17p, with careful monitoring and recording, at a minimum, of temperature and pH at the beginning and end of the cooling period.

Milk Processing Room: All milk processing, including pasteurizing and cheesemaking, must be done in a room separate from the milk room. Raw milk may not be stored in the processing room, unless piped directly into pasteurization equipment (vat or balance tank), but all milking equipment, buckets and utensils must be washed and stored in the milk room/milkhouse. The processing room may not open directly into the barn or the milking parlor. The processing room may open into the milk room provided there is a solid, self-closing door between the rooms. The processing room should not be located so that it is used for routine traffic in and out of the milk room. Floors, walls, ceilings, lighting, ventilation, water, and sink requirements are the same as for the milk room. If pasteurized milk is being bottled and sold in returnable bottles, bottles may be hand washed provided the processing room is equipped with a 3 bay wash sink for washing and sanitizing the bottles. However, it is highly recommended that the plant be equipped with a proper bottle washer. All milk room and processing room waste which does not go into a sanitary sewer must go into a system that meets the standards of the USDA Natural Resources Conservation Service (NRCS). A septic system is generally not recommended for milk room and cheese room waste. All containers, utensils, and equipment must be made of glass, stainless steel, or other non-toxic and corrosion resistant metals, or durable plastic, rubber or rubber-like materials which cannot be easily scratched or scored and which are non-toxic.

Bottling Pasteurized Milk: Pasteurized milk shall be bottled in a sanitary manner by approved mechanical equipment. Capping of milk containers is also required to be done in a sanitary manner and using approved mechanical equipment. Caps may be hand slotted into the capper provided the person handling the caps is wearing a clean pair of gloves.

Pasteurizers: The pasteurizer must meet the requirements in the Pasteurized Milk Ordinance. Stove top or home use type pasteurizers that are currently available are not acceptable. The simplest pasteurizer available is the vat pasteurizer. Milk is held in the vat at a minimum temperature of 145° for at least 30 minutes. A vat pasteurizer must have:

• Three Thermometers:
  1. an indicating thermometer. This is the official thermometer;
  2. a recording thermometer. This provides the record of legal pasteurization and is checked daily against the indicating thermometer, and
  3. an air space thermometer. This checks the temperature of the air between the top of the milk and the lid of the pasteurizer. This temperature needs to be at least 150° to ensure that any foam on top of the milk is properly pasteurized.
• An agitator to mix the milk.
• A shoe box type lid with raised edges around any openings in the lid.
• The outlet valve needs to be a leak protector type which allows any milk leaking past the valve to be diverted to the floor.

Vat pasteurizers work by having very hot water in a jacket surrounding the milk which in turn heats the milk. Most small vats have built in elements that heat the water in the jacket. Larger vat pasteurizers may require external hot water sources, generally a boiler to produce hot enough water.

The other common pasteurizer is the high temperature short time (HTST) which pumps the milk through a plate heat exchanger with hot water on the other side, a holding tube, past thermometers and then through a cooling unit after the milk has been pasteurized. Milk is heated to 161° for at least 15 seconds. At the very least an HTST requires:

• A raw milk balance tank the top of which is below the lowest part of the heat exchanger,
• A positive displacement pump or homogenizer to pump the milk through the unit,
• An indicating thermometer located at the end of the holding tube,
• A recorder/controller with a recording thermometer located in close proximity to the indicating thermometer,
• A diversion valve which automatically diverts milk below pasteurization temperature/pressure back to the raw milk balance tank,
• A boiler for heating water to heat the milk,
• A chilled water source for cooling the milk, and
• Access to the beginning and end of the holding tube for measuring the holding time.

After receiving a completed application form, the establishment will be contacted by the Dairy Project Coordinator with instructions. Facilities that will be pasteurizing milk will be subject to a pre-operational inspection. All other facilities will be instructed to begin operations followed by an unannounced operational inspection.

Inspections of milk plants are conducted at least once every 3 months with follow-up if any critical violations are found or if the inspection score is rated “conditionally satisfactory”. Critical violations include:

• Improper milking of treated animals;
• Improperly protected or unsafe water supplies;
• Unclean milking equipment;
• Improper cooling of milk; and
• Improper labeling on extra-label drugs. These are drugs not specifically labeled for the species of animal they are being used on or for the condition they are being used to treat.

If the inspector observes a critical violation which, in the opinion of the inspector, may cause imminent harm to public health, then the establishment will be rated “unsatisfactory” and be asked to voluntarily close. Establishments that refuse to close will be subject to enforcement actions, including injunctive relief.

Inspections of milk products processing facilities are conducted as needed, with the Dairy Project’s goal of inspection at least once a year with follow-up if any critical violations are found. Critical violations include:

• Improperly protected or unsafe water supplies;
• Unclean equipment;
• Cross connections between raw and pasteurized products;
• Improperly pasteurized products;
• Adulteration of milk;
• Improper cooling of milk.

Plant inspections are normally conducted unannounced. If arrangements have to be made for an announced inspection, such as for seasonal or limited-hours establishments, then the Dairy Project expects that the sanitary conditions, records, etc. of the establishment will be nearly flawless.

Pasteurizers in milk plants are checked every 3 months and in milk products plants, at least once per year, to make sure they are working properly. For a vat pasteurizer this involves checking the thermometers, checking that the leak detect valve is working properly, and checking to make sure the timing device is accurate. For an HTST pasteurizer this includes, checking the thermometers, operation of the valves, the temperature at which the diversion valve move into forward flow and back to diverted flow. The holding time is checked every 6 months. If pasteurized milk or yogurt is to be sold across state lines the facility must be inspected by a federally certified state inspector and by the federal Food and Drug Administration.

All containers and closures must be stored and handled in a sanitary manner to prevent contamination. Single-service containers and closures can not be reused. Multiple use containers must be washed, rinsed, sanitized and drained no more than 4 hours prior to filling, such as by using a 3-compartment sink or a commercial dishwasher with a chemical sanitizer step. Any returned bottles with visible filth or contamination shall not be refilled. Any person filling and capping bottles must wear effective hair coverings, and shall wash their hands immediately prior to starting and as necessary throughout the filling operation. Fluid milk products and milk products shall be kept cooled to a temperature of 45 degrees Fahrenheit or less. All silos, bulk milk storage tanks, or other containers used to store raw milk prior to bottling must be washed and sanitized at least once every 72 hours. Tankers must be washed and sanitized at least once every 96 hours.

All containers of fluid milk products shall be labeled with an unambiguous “sell by” or “not to be sold after” date, and the milk shall remain in compliance with quality standards until the sell by date. Shelf life dates are determined by the processor, based upon scientific analyses. If the shelf life is longer than normal industry practices, then the Dairy Project will require scientific and organoleptic data (e.g. Virginia Tech method, Moseley stress test, etc.) to be submitted along with the Project’s Shelf Life All other labeling requirements as per Section 4 of the PMO apply. All milk products shall be labeled with a meaningful, traceable lot code in any form desired by the processor. All applicable labeling requirements of 21 CFR apply as well.

TESTING OF PRODUCTS BY THE DAIRY PROJECT:

Raw milk for processing and pasteurized milk samples are collected for testing at least 4 out of every 6 months. Notices of high bacterial and somatic cell counts are issued as warnings and additional follow-up testing is done if any 2 out of the last 4 samples exceed the standard. Licenses are suspended if any 3 out of the last 5 samples exceed the standard. pathogens.

Raw milk for processing is tested for:

• Bacteria (standard plate count),
• Somatic cell count,
• Antibiotic residues, and
• Temperature.

Tests can also be run for butterfat and total solids.

Pasteurized milk samples are tested for:

• Bacteria (standard plate count),
• Coliform bacteria,
• Butterfat,
• Phosphatase (an enzyme which if present indicates improper pasteurization),
• Antibiotic residues, and
• Temperature.

Yogurt and cultured fluid milk products: Cultured fluid milk products are sampled and tested with the same frequency as pasteurized milk except that cultured fluid milk products are only tested for Coliform bacteria and butterfat.

Ice Cream and other frozen dessert products: As per N.J.A.C. 8:21-7.28, processors are required to obtain samples and have analyzed at least 4 samples in any given 6 months of operation, for each standard of identity (e.g. ice cream, frozen yogurt, water ice, novelties, etc). Frozen desserts shall not exceed 50,000 bacteria/gram nor more than 10 coliforms/gram, except for frozen desserts that contain bulky ingredients (fruit, candy, nuts, etc.), in which case they cannot exceed more than 20 coliforms/gram. Occasionally, the Dairy Project will take random samples from processors and test them at the state laboratory for the same parameters.

Cheeses made from either raw or pasteurized milk are randomly tested for E.coli O157:H7, Listeria, Salmonella, Campylobacter, and Staphylococcus Aureus.

Water: Water is tested for coliform bacteria. Water obtained from public water supplies is not tested. Water supplies for milk processing operations are tested at least once every 6 months if the well is buried; or at least once every 3 years if the well cap is above ground. Water supplies that need continuous disinfection are tested at least once every 6 months. Follow-up samples are collected if any sample shows the presence of coliform bacteria. Water samples are collected by the Dairy Project and taken to the state lab.

Milk bottles: At Grade “A” milk plants listed on the Interstate Milk Shippers (IMS) list, returnable bottles are tested 4 months out of 6. A set of 4 washed, sanitized and capped empty bottles is considered a sample. Bottles may be tested more frequently if there appears to be contamination of the milk. At non-IMS listed plants which use and wash returnable bottles for any milk or milk products, raw or pasteurized, the returnable bottles will be tested if bacteria counts indicate the cleaning and sanitizing of the bottles is not effective to prevent contamination of the product.

TESTING CONDUCTED BY THE PRODUCER/PROCESSOR:

Prior to processing, all milk must be tested for antibiotics using an approved test. Prior to the pasteurization of raw milk, all milk must be tested for antibiotics using an approved test. If any milk is received from another farm, the milk must be tested for antibiotics prior to processing or to commingling with milk produced on your own farm. Antibiotic tests suitable for use on farms include:

• Charm II or Charm SL,
• DELVOTEST, (Available from Nelson Jameson);
• Snap test. (Idexx Laboratories, Inc.)
  Note: the Snap test has not been approved for goat milk. All milking animals shall be tested for tuberculosis and brucellosis within the 12 months prior to a producer-plant obtaining a license and once every 3 years thereafter.
  
  Quality Standards:
  • Bacterial (standard plate count) standard:
    • Raw milk intended for processing: 100,000/ml.
    • Pasteurized Milk: 20,000/ml
    • Somatic cell count:
      • Cows and Sheep Milk: 750,000/ml
      • Goats Milk: 1,500,000/ml for milk intended for consumption as fluid milk.
    • Antibiotic residues: none present
    • Pathogens: none
    • Phosphatase: no more than 350 mill Units/ml.
    • Water: No coliform present.

Bulk Milk and Milk Plant License: $50 per year if supplied by a total of 25 farms or less; $100 per year if supplied by more than 25 farms.

Frozen Desserts License: $100 per year if gross annual wholesale sales is less than $100,000; $300 per year if gross annual wholesale sales is between $100,000 and $500,000; and $500 per year per year if gross annual wholesale sales is greater than $500,000.

Wholesale Food and Cosmetic Establishment License (cheese and butter plants): $150 per year if gross annual wholesale sales is less than $100,000; $500 per year if gross annual wholesale sales is between $100,000 and $500,000; and $1000 per year per year if gross annual wholesale sales is greater than $500,000.

Inspections: There is no fee for inspections, including pasteurizer tests, sampler evaluations, tanker inspections, etc.

Sample testing: There is no fee for compliance samples obtained by the Dairy Project. Fees for sample analyses at third party laboratories will vary. It is up to the individual processor to select a third party laboratory, as long as it is certified by its respective state agency to conduct milk and milk product testing. Analytical reports shall be made available to the Dairy Project upon request.