CFSAN/Office of Compliance
March 2, 2004
(Refer to the last NOTE: in Section 6.)
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 |
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. (Refer to 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. (Refer to 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, only Grade "A" milk and milk products shall be sold to milk plants for use in the commercial preparation of Grade "A' milk and milk products. Provided further, 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 products that have 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:
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:
NOTE: Raw and pasteurized milk and milk products beyond the limits of routine inspection shall be sampled as the Regulatory Agency requires.
NOTE: Names of interstate milk shippers and their ratings, as reported by State Rating Agencies, are contained in the IMS List-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/Regulatory Agency or from the Food and Drug Administration, HFS-626, 5100 Paint Branch Parkway, College Park, MD 20740-3835.
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 pasteurized milk or milk products or which brings them into direct contact with associated pasteurized or aseptically processed milk or milk product-contact surfaces.
In the case of milk plants, receiving stations, or transfer stations that have HACCP Systems, which are regulated under the NCIMS HACCP Program, the HACCP System shall address the public health concerns described in this Section in a manner that provides protection equivalent to the requirements in this Section.
Milk plant operators who have received reports, under this Section, from employees who have handled pasteurized milk or milk products or associated milk or milk product-contact surfaces shall immediately report these facts to the appropriate Milk Regulatory Agency.
Milk plant employees, or applicants to whom a conditional offer of employment has been made, shall be instructed by the milk plant that the employee or applicant or applicants to whom a conditional offer of employment has been made is responsible to report to the milk plant management, in a manner that allows the milk 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:
When a person who may have handled pasteurized or aseptically processed milk or milk products or pasteurized or aseptically processed milk or milk product-contact surfaces meets one (1) or more of the conditions specified in the Administrative Procedures of Section 13, the Milk Regulatory Agency is authorized to require any or all of the following measures:
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. |
NOTE: Persons at risk who decline to be examined may be reassigned to duties where they will not be required to handle pasteurized, ultra-pasteurized or aseptically processed milk or milk products and associated milk or milk product-contact surfaces.
In the case of milk plants, receiving stations, or transfer stations that have HACCP Systems, which are regulated under the NCIMS HACCP Program, the HACCP System shall address the public health concerns described in this Section in a manner that provides protection equivalent to the requirements in this Section.
This Ordinance shall be enforced by the Regulatory Agency in accordance with the Grade "A" PMO, with Administrative Procedures, current edition. 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.