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U.S. Department of Health and Human Services |
All milk for pasteurization shall be from herds in Areas which have a Modified Accredited Advanced Tuberculosis status or greateras determined by the U.S. Department of Agriculture (USDA). Provided, that in an Area which fails to maintain such status, any herd shall have beenaccredited by said Department as tuberculosis free, or shall have passed an annual tuberculosis test, or the Area shall have established a tuberculosis testing protocol for livestock that assures tuberculosis protection and surveillance of the dairy industry within the Area and that it isapproved by FDA, USDA and the Regulatory Agency.
All milk for pasteurization shall be from herds under a brucellosis eradication program, which meets one (1) of the following conditions:
Located in a Certified Brucellosis-Free Area as defined by USDA and enrolled in the testing program for such areas; or
Meet USDA requirements for an individually certified herd; or
Participating in a milk ring testing program at least two (2) times per year at approximately one hundred eighty (180) day intervals and all herds with positive milk ring results shall have the entire herd blood tested within thirty (30) days from the date of the laboratory ring tests; or
Have an individual blood agglutination test annually with an allowable maximum grace period not exceeding two (2) months.
Goat milk and sheep milk for pasteurization or ultra-pasteurization or aseptic processing shall be from a herd or flock which:
Has passed an annual whole herd or flock brucellosis test as recommended by the State Veterinarian or USDA Area Veterinarian in Charge (AVIC); or
Has passed an initial whole herd brucellosis test, followed only by testing replacement animals or any animals entering the milking group or sold as dairy animals; or
Has passed an annual random blood-testing program sufficient to provide a confidence level of 99% with a P value of 0.05. Any herd or flock with one (1) or more confirmed positive animals shall go to 100% testing until the whole herd tests show no positive animals are found; or
Has passed a USDA approved bulk milk test, at USDA recommended frequency, with an implementation date based on availability of the test.
The following table13 will provide the random sampling size needed to achieve 99% confidence with a P value of 0.05.
| Herd/Flock Size |
Sampling Size |
Herd/Flock Size |
Sampling Size |
|---|---|---|---|
| 20 | 20 | 500 | 82 |
| 50 | 41 | 600 | 83 |
| 100 | 59 | 700 | 84 |
| 150 | 67 | 800 | 85 |
| 200 | 72 | 1000 | 86 |
| 250 | 75 | 1400 | 87 |
| 300 | 77 | 1800 | 88 |
| 350 | 79 | 4000 | 89 |
| 400 | 80 | 10000 | 89 |
| 450 | 81 | 100000 | 90 |
For diseases other than brucellosis and tuberculosis, the Regulatory Agency shall require such physical, chemical or bacteriological tests, as it deems necessary. The diagnosis of other diseases in dairy animals shall be based upon the findings of a licensed and accredited14 veterinarian or an accredited veterinarian in the employ of an official Agency. Any diseased animal disclosed by such test(s) shall be disposed of as the Regulatory Agency directs.
Records supporting the tests required in this Section shall be available to the Regulatory Agency and be validated with the signature of a licensed and accredited veterinarian or an accredited veterinarian in the employ of an official agency.
The health of the animal is a very important consideration, because a number of diseases of cattle, including tuberculosis, brucellosis, Q-fever, salmonellosis, staphylococcal infection and streptococci infection, may be transmitted to man through the medium of milk. The organisms of most of these diseases may get into the milk either directly from the udder, or indirectly through infected body discharges which may drop, splash or be blown into the milk.
The great reduction in the incidence of bovine tuberculosis in man indicates that the practice of good sanitation in animal husbandry, the testing of dairy animals and removal of the reactors from the herds and the pasteurization of milk, have been effective in the control of this disease. The reservoir of bovine tuberculosis still exists; however, constant vigilance against this disease must be continued by industry and Regulatory Agencies.
BOVINE TUBERCULOSIS: All tuberculin tests and retests shall be made, and any reactors disposed of, in accordance with the current edition of Uniform Methods and Rules; Bovine Tuberculosis Eradication, Uniform Methods and Rules for Establishment and Maintenance of Tuberculosis-Free Accredited Herds of Cattle, Modified Accredited Areas and Areas Accredited Free of Bovine Tuberculosis in the Domestic Bovine, as published by USDA. For tuberculosis test purposes, the herd is defined as all adult cattle twenty-four (24) months of age and over, including any commingled beef animals. Dairy cattle less than two (2) years of age and already milking shall be included in the herd test. A letter or other official correspondence attesting to the accreditation status of the locality in which the herd is located, including the date of accreditation, or a certificate identifying the animals tested, the date of injection, the date of reading of the test and the results of the test signed by a USDA accredited veterinarian, shall be evidence of compliance with the above requirements and shall be filed with the Regulatory Agency. (See Appendix A.)
BOVINE BRUCELLOSIS: All brucellosis tests, retests, disposal of reactors, vaccination of calves and certification of herds and areas shall be in accordance with the current edition of Brucellosis Eradication, Recommended Uniform Methods and Rules, as published by USDA. All reactors disclosed on blood agglutination tests shall be separated immediately from the milking herd and the milk of these reactors shall not be used for human consumption.
A certificate identifying each animal, signed by the veterinarian and the director of the laboratory making the test, shall be filed as directed by the Regulatory Agency. Provided, that in the event the herd is subject to the milk ring test, the record shall be required to show only the date and results of such test. Within thirty (30) days following the expiration of an official milk ring testing program, or in the case of a herd subject to annual blood tests, thirteen (13) months following the last annual blood tests, the Regulatory Agency shall notify the herd owner or operator of the necessity to comply with the brucellosis requirements. The failure of the herd owner or operator to comply with the brucellosis requirements within thirty (30) days of written notice shall result in immediate suspension of the permit. (See Appendix A.)
From and after twelve (12) months from the date on which this Ordinance is adopted, only Grade "A" pasteurized, ultra-pasteurized, or aseptically processed milk and milk products shall be sold to the final consumer, to restaurants, soda fountains, grocery stores or similar establishments. Provided, that in an emergency, the sale of pasteurized milk and milk products, which have not been graded, or the grade of which is unknown, may be authorized by the Regulatory Agency, in which case, such milk and milk products shall be labeled "ungraded".
Except as permitted in this Section, no milk producer, bulk milk hauler/sampler or distributor shall transfer milk or milk products from one (1) container or milk tank truck to another on the street, in any vehicle, store or in any place except a milk plant, receiving station, transfer station or milkhouse especially used for that purpose. The dipping or ladling of milk or fluid milk products is prohibited.
It shall be unlawful to sell or offer for sale any pasteurized milk or milk product that has not been maintained at the temperature set forth in Section 7 of this Ordinance. If containers of pasteurized milk or milk products are stored in ice, the storage container shall be properly drained.
TRANSFERRING: The dipping or ladling of milk and fluid milk products is expressly prohibited, except for immediate cooking purposes. Milk and milk product containers, which have been filled and sealed at a milk plant, shall be used for the delivery of milk or milk products. Caps, closures or labels shall not be removed or replaced during transportation.
BULK DISPENSERS: Bulk dispensers, approved by the Regulatory Agency, shall satisfy the following sanitary design, construction and operation requirements:
All dispensers shall comply with the applicable requirements of Section 7 of this Ordinance.
Product-contact surfaces shall be inaccessible to manual contact, droplet infection, dust or insects, but the delivery orifice may be exempted from this requirement.
All parts of the dispensing device with which milk or milk products come into contact, including any measuring device, shall be thoroughly cleaned and sanitized at the milk plant. Provided, that dispensing valves, which are applied to the dispenser subsequent to its delivery to the retail vendor may be cleaned and sanitized at such establishments.
The dispensing container shall be filled at the milk plant and shall be sealed so that it is impossible to withdraw any part of its contents, or to introduce any substance without breaking the seal(s).
The milk or milk products shall be thoroughly and automatically mixed with each dispensing operation, except for milk or milk products that remain homogeneous.
All cans shall be thoroughly cleaned and sanitized. Milk and milk products shall be kept at or below 7°C (45°F) at all times. The dispenser tube shall be integral with the dispensing container, shall be protected and shall be under adequate refrigeration during transportation and storage.
Milk and milk products from points beyond the limits of routine inspection of the ... of... or its jurisdiction, shall be sold in ...,1 or its jurisdiction, provided they are produced and pasteurized, ultra-pasteurized or aseptically processed under regulations which are substantially equivalent to this Ordinance and have been awarded acceptable Milk Sanitation Compliance and Enforcement Ratings.
The Regulatory Agency should accept, without their actual physical inspection, supplies of milk and milk products from an area or an individual shipper not under their routine inspection. Provided, that:
Milk and milk products upon arrival shall comply with bacteriological, chemical and temperature standards of Section 7. Provided, that direct shipped producer milk that is under the supervision of more than one (1) Regulatory Agency may be exempt from the bacteriological requirement for commingled samples. However, the receiving Regulatory Agency shall have the right to use the individual producer samples to determine compliance with the bacteriological standards;
After receipt, pasteurized, ultra-pasteurized, or aseptically processed milk and milk products shall comply with Sections 2, 4 and 10;
NOTE: Raw and pasteurized milk and milk products beyond the limits of routine inspection shall be sampled, as the Regulatory Agency requires.
The milk or milk products are produced and processed under regulations substantially equivalent to those of this Ordinance;
The supplies are under routine official supervision;
The supplies have been awarded, by a State Milk Sanitation Rating Officer (SRO) certified by FDA, Milk Sanitation Compliance and Enforcement Ratings equal to that of the local supply or equal to ninety percent (90%) or higher; and
All ratings are made on the basis of procedures outlined in the Methods of Making Sanitation Ratings of Milk Supplies (MMSR).
NOTE: Names of interstate milk shippers and their ratings, as reported by State Milk Rating Agencies, are contained in the Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List), issued semi-annually by FDA. Copies of this list may be obtained from the State Milk Rating or Regulatory Agency or from the Food and Drug Administration, HFS-626, 5100 Paint Branch Parkway, College Park, MD 20740-3835.
The supplies have been awarded, a satisfactory listing, by a State Listing Officer, standardized by FDA, under the NCIMS HACCP Pilot Program Phase II Expansion. This provision will expire on December 31, 2003 unless extended by future Conference action.
Properly prepared plans for all milkhouses, milking barns, stables and parlors, milk tank truck cleaning facilities, milk plants, receiving stations and transfer stations regulated under this Ordinance, which are hereafter constructed, reconstructed or extensively altered shall be submitted to the Regulatory Agency for written approval before work is begun.
No persons affected with any disease capable of being transmitted to others through the contamination of food shall work at a milk plant in any capacity which brings them into direct contact with finished products, such as pasteurized or aseptically processed milk or milk products, or which brings them into direct contact with associated pasteurized or aseptically processed milk product-contact surfaces.
Milk plant operators who have received reports, under this Section, from employees who have handled pasteurized milk, pasteurized milk products or associated product-contact surfaces shall immediately report these facts to the appropriate milk Regulatory Agency.
Dairy plant employees, or applicants to whom a conditional offer of employment has been made, shall be instructed by the dairy plant that the employee or applicant or applicants to whom a conditional offer of employment has been made is responsible to report to the dairy plant management, in a manner that allows the dairy plant to prevent the likelihood of the transmission of diseases that are transmissible through foods, if the employee or applicant to whom a conditional offer of employment has been made:
Is diagnosed with an illness due to Hepatitis A virus, Salmonella typhi, Shigella species, Norwalk and Norwalk-like Viruses, Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli 0157:H7, enterohemorrhagic Escherichia coli, enterotoxigenic Escherichia coli, Campylobacter jejuni, Entamoeba histolytica, Giardia lamblia, Non-typhoidal Salmonella, Rotovirus, Taenia solium, Yersinia enterocolitica, Vibrio cholerae O1 or other infectious or communicable disease that has been declared by the Secretary of Health and Human Services (HHS) to be transmissible to others through the handling of food, or has been clearly shown to be so based upon verifiable epidemiological data; or
Is exposed to, or suspected of causing, a confirmed foodborne disease outbreak of one (1) of the diseases specified in Item 1 above, including an outbreak at an event such as a family meal, church supper or ethnic festival because the employee or applicant to whom a conditional offer of employment has been made:
Prepared food implicated in the outbreak; or
Consumed food implicated in the outbreak; or
Consumed food at the event prepared by a person who is infected or ill.
Lives in the same household as a person who attends or works in a day care center or school, similar institution experiencing a confirmed outbreak of one (1) of the diseases specified in Item 1 above.
Similarly, dairy plant employees shall be instructed by the dairy plant management to report to the dairy plant management if the employee, or applicant to whom a conditional offer of employment has been made.
Has a symptom associated with acute gastrointestinal illness such as: abdominal cramps or discomfort, diarrhea, fever, loss of appetite for three (3) or more days, vomiting, jaundice; or
Has a pustular lesion such as a boil or infected wound that is:
On the hands, wrists or exposed portions of the arms, unless the lesion is covered by a durable, moisture proof, tight-fitting barrier, or
On other parts of the body if the lesion is open or draining, unless the lesion is covered by a durable, moisture proof, tight-fitting barrier.
When a person who may have handled pasteurized or aseptically processed milk or milk products or pasteurized or aseptically processed milk product-contact surfaces meets one (1) or more of the conditions specified in the Administrative Procedures of Section 13, the Regulatory Agency is authorized to require any or all of the following measures:
The immediate restricting of that person from duties that require handling finished product, such as pasteurized milk or milk products, or the handling of related product-contact surfaces. This restriction may be lifted after an appropriate medical clearance or cessation of symptoms or both, according to the following Table:
| Table 5. Removal of Restrictions when Infection or High Risk of Infection is Discovered | |
|---|---|
| Health Status | Removing Restrictions |
| a. Is diagnosed with an illness due to Hepatitis A virus, Salmonella typhi, Shigella species, Norwalk and Norwalk-like Viruses, Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli 0157:H7, enterohemorrhagic Escherichia coli, enterotoxigenic Escherichia coli, Campylobactor jejuni, Entamoeba histolytica, Giardia lamblia, Non-typhoidal Salmonella, Rotovirus, Taenia solium, Yersinia enterocolitica, Vibrio cholerae O1 or other infectious or communicable disease that has been declared by the Secretary of HHS to be transmissible to others through the handling of food or has been clearly shown to be so based upon verifiable epidemiological data. | Restrictions lifted by medical clearance. |
| b. Meeting a high-risk scenario as specified in Section 13 (2 or 3) and/or experiencing symptoms in Section 13 (4 or 5). | Restrictions lifted when symptoms cease or medical documentation is provided that infection does not exist. |
| c. Asymptomatic, but stools positive for Salmonella typhi, Shigella or Escherichia coli 0157:H7. | Restrictions lifted by medical clearance. |
| d. Past illness from Salmonella typhi, Shigella, Escherichia coli 0157:H7 or other human pathogens for which humans have been determined to be carriers. | Restrictions lifted by medical clearance. |
| e. In the case of diagnosed or suspected Hepatitis A, onset of jaundice within the last seven (7) days. | Restrictions lifted by medical clearance. |
| f. In the case of diagnosed or suspected Hepatitis A, onset of jaundice occurred more than seven (7) days ago. | Restrictions lifted by medical clearance or jaundice ceases. |
The immediate exclusion of the affected dairy products from distribution and use when medically appropriate, i.e., a medical evaluation of the sequence of events indicates that contamination of product may have occurred.
The immediate requesting of medical and bacteriological examination of the person at risk.
NOTE: Persons at risk who decline to be examined may be reassigned to duties where they will not be required to handle finished products, such as pasteurized, ultra-pasteurized or aseptically processed milk or pasteurized or aseptically processed milk products and associated product-contact surfaces.
This Ordinance shall be enforced by the Regulatory Agency in accordance with the Grade "A" Pasteurized Milk Ordinance with Administrative Procedures, 2001 Revision. A certified copy15 of which shall be on file at the appropriate Regulatory Agency's office. Where the mandatory compliance with provisions of the Appendixes is specified, such provisions shall be deemed a requirement of this Ordinance.
Any person who shall violate any of the provisions of this Ordinance shall be guilty of a misdemeanor and upon conviction thereof shall be punished by a fine of not more than $ ... and/or such persons may be enjoined from continuing such violation(s). Each day upon which such a violation(s) occurs shall constitute a separate violation.
All ordinances and parts of ordinances in conflict with this Ordinance shall be repealed twelve (12) months after the adoption of this Ordinance, at which time this Ordinance shall be in full force and effect, as provided by law.
Should any Section, paragraph, sentence, clause or phrase of this Ordinance be declared unconstitutional or invalid for any reason, the remainder of this Ordinance shall not be affected thereby.