§303. Delivery of Samples

A. All persons engaged in the production, processing, handling or selling of milk, milk products or other dairy products shall deliver to the state health officer, upon request, samples of the dairy products in his possession. The state health officer shall not be required to pay for these samples. Any refusal to deliver such samples in his possession shall be deemed a violation of these regulations. All samples so collected shall be sealed, when possible, in the presence of the person from whom taken.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S.40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7) (15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2650 (September 2011).

§305. Samples and Examinations

A. Samples of milk, milk products or other dairy products from stores, soda fountains, restaurants, finished product depots and other places where dairy products are handled, stored or sold shall be examined to determine compliance with the product standards contained in this Part as often as the state health officer may require.

B. The state health officer shall collect samples of milk, milk products or other dairy products being sold within the state that were processed by each dairy plant domiciled in other states or countries and test them for compliance with the standards for such products contained in this Part as required by the state health officer.

C. Samples of milk, milk products or other dairy products shall be taken prior to sale to the final consumer. Samples of dairy products collected from containers other than dairy product storage, processing or bulk transportation tanks or totes that have been opened/uncapped shall not be considered official.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S.40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7) (15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2650 (September 2011).

§307. The Official Sampling of Dairy Plant Environments and Dairy Products Including Frozen Desserts

A. Each bulk milk tank truck operator/sampler shall collect a representative sample of raw milk from each farm bulk tank prior to transferring the milk from the farm bulk tank to a milk tank truck each time raw milk is removed from the farm bulk tank. All samples shall be collected as directed by the state health officer and at least one set of samples collected from each farm bulk tank of each dairy farm supply represented in the load shall accompany the load of milk to the dairy plant, receiving station or transfer station at which it is unloaded.

B. Each dairy plant receiver/sampler shall collect a representative sample of raw milk from each tanker of raw milk that unloads at the plant each day. The dairy plant receiver/sampler shall obtain one set of the samples, collected by the bulk milk tank truck operator sampler, from each farm bulk tank of raw milk represented on the loads of raw milk from which the tanker samples were obtained. The dairy plant receiver/sampler shall store all of the samples in a manner consistent with the requirements of this Part and deliver them to the state health officer when requested.

C. The state health officer may sample the environments of each dairy plant using approved methodology for the sampling of plant environments for contamination with pathogenic microorganisms of human significance as often as he deems necessary. Controlling the environments of dairy plants to prevent contamination with pathogenic microorganisms is of utmost public health importance.

D. During each consecutive six months, at least four samples of raw milk for pasteurization, ultra-pasteurization and aseptic processing shall be collected in at least four separate months, except when three months show a month in which two of the sampling dates were separated by at least 20 days, and delivered in accordance with the requirements of this section from each farm bulk tank of each producer. These samples shall be obtained under the direction of the state health officer or shall be collected from each producer by the state health officer.

E. During each consecutive six months, at least four samples of commingled raw milk for pasteurization, ultra-pasteurization or aseptic processing, collected in at least four separate months, except when three months show a month containing two sampling dates separated by at least 20 days, shall be taken from each dairy plant after receipt of the milk by the plant and prior to pasteurization, ultra-pasteurization or aseptic processing by the state health officer.

F. During each consecutive six months, at least four samples of heat-treated milk and milk products, from each plant offering such products for sale, shall be collected in at least four separate months, except when three months show a month containing two sampling dates separated by at least 20 days, by the state health officer.

G. During each consecutive six months, at least four samples of each type of dairy product being processed by each dairy plant domiciled within the state shall be collected by the state health officer. Each fat level of product, each flavor of flavored products, and each type of cultured product shall be sampled by the state health officer. The state health officer shall attempt to collect these samples of product in each size and type of container packaged by each plant.

H. During each consecutive 12-month period the state health officer shall collect from each dairy plant domiciled in Louisiana at least one sample of each dairy product to which vitamins have been added.

I. If production of any dairy product, for which a grading system is prescribed by this Part, is not on a yearly basis at least five samples shall be taken within a continuous production period.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7) (15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2650 (September 2011).

§309. Laboratory Examination of Dairy Products Including Frozen Desserts and Tests for Environmental Pathogens

A. The following laboratory examinations shall be performed on milk and dairy products, including frozen desserts:

1. Standard plate counts, drug residue tests, somatic cell counts and cooling temperature checks shall be performed on raw milk for pasteurization, ultra-pasteurization and aseptic processing from each producer’s milk supply domiciled in the state at a frequency required in §307.D on samples collected by the state health officer or under the direction of the state health officer.

2. Standard plate counts, drug residue tests and cooling temperature checks shall be performed on commingled raw milk for pasteurization, ultra-pasteurization and aseptic processing from the supply of each dairy plant domiciled in Louisiana at a frequency required in §305.E on samples collected by the state health officer.

3. Sediment tests, tests for aflatoxins, beta lactams, tetracyclines, sulfonamides, tests for added water and other tests determined to be necessary by the state health officer shall be performed on raw milk samples collected from each farm bulk milk tank truck load of raw milk that unloaded at each dairy plant, transfer station and receiving station on two consecutive days during each consecutive six month period. These tests shall be performed at the Milk and Dairy Residue Monitoring Facility.

4. All raw milk samples collected from each farm bulk milk tank represented on each load of raw milk that was found to have a USDA sediment standard that exceed number three or was found to be positive for any of the other tests listed in §309.A.3 above shall be tested using the same test from which the sediment result that exceed three or the positive result on the other tests were obtained on the sample from the load of raw milk. These tests shall be performed at the Milk and Dairy Residue Monitoring Facility.

5. Standard plate counts, drug residue tests and temperature checks, which are determinated to be necessary by the state health officer, shall be performed on each type of heat treated dairy product processed by each dairy plant domiciled in the state at a frequency required in §307.F on samples collected by the state health officer.

6. Standard plate counts, coliform counts, drug residue tests, phosphatase tests and cooling temperature checks, which are determined to be necessary by the state health officer shall be performed on each type of dairy product, including frozen desserts, processed by each dairy plant domiciled in the state at a frequency required in §307.G on samples collected by the state health officer or under the direction of the state health officer,

7. Standard plate counts, drug residue tests, coliform counts and cooling temperature checks shall be performed on condensed and concentrated dairy products produced by each dairy plant domiciled in the state at a frequency required in §307.G on samples collected by the state health officer or under the direction of the state health officer,

8. Standard plate counts and coliform counts shall be performed on each type of dry dairy product processed or blended by each dairy product drying or dairy product blending plant domiciled in the state at a frequency required in §307.G on samples collected by the state health officer or under the direction of the state health officer,

9. Drug residue tests determined to be appropriate by the state health officer shall be performed on each type of aseptically processed dairy product produced by each dairy plant domiciled in the state at a frequency required in §307.G on samples collected by the state health officer or under the direction of the state health officer.

10. Tests for contamination of finished products with pesticides, herbicides, PCB’s, etc., shall be performed at intervals determined by the state health officer, on all finished products being sold or produced in Louisiana.

B. All sampling procedures and required laboratory examinations shall be conducted in laboratories approved by the state health officer and shall be in substantial compliance with the requirements of the PMO, the Standard Methods for the Examination of Dairy Products, the Official Methods of Analysis. Such procedures, including the certification of sample collectors and examinations shall be evaluated by the state health officer in accordance with the Evaluation of Milk Laboratories. Aseptically processed milk and milk products packaged in hermetically sealed containers shall be tested in accordance with the Bacteriological Analytical Manual. Examinations and tests to detect adulterants, including pesticides, shall be conducted as the state health officer requires. Assays of dairy products to which vitamin A, vitamin D or vitamins A and D have been added, shall be made at least annually in a laboratory which has been accredited by the U. S. Food and Drug Administration and which is acceptable to the state health officer, using test methods acceptable to the FDA and other official methodologies which give results statistically equivalent to the FDA methods.

C. All facilities fortifying products with vitamins shall keep volume control records. These volume control records shall cross reference the form and amount of vitamin D, vitamin A or vitamins A and D used with the amount of product produced and indicate a percent (plus or minus) of expected use.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7) (15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2651 (September 2011).

Subchapter B. Inspections/Audits

§311. Frequency of Inspections/Audits

A. Each dairy farm, dairy plant including frozen desserts manufacturing plant, filled dairy products manufacturing plant, anomalous milk and milk products and other anomalous dairy product manufacturing plant, receiving station, milk tank truck cleaning facility, transfer station, single-service containers and closures for milk and milk products manufacturing plant, finished product depot/transfer point and dairy plant receiver/sampler, bulk milk tank truck operator/sampler and milk tank truck domiciled or operating in the state shall be inspected/audited by the state health officer prior to the issuance of a permit.

B. Following the issuance of a permit the state health officer shall:

1. Inspect the receiving, processing/packaging, cleaning, pre-operation and start-up procedures of each dairy plant including frozen dessert manufacturing plants at least once each month. (For the purposes of this Paragraph, the term “dairy plant” used herein shall not include receiving stations, transfer stations, single-service containers and closures for milk and milk products manufacturing plants, milk tank truck cleaning facilities and finished product depot/transfer points.)

2. Inspect receiving stations, transfer stations, single-service containers and closures for milk and milk products manufacturing plants, milk tank truck cleaning facilities and finished product depot/transfer point at least once each three months.

3. Inspect/audit each dairy plant, including frozen dessert manufacturing plants, that are required by the state health officer to implement HACCP systems or have been authorized by the state health officer to be regulated under the HACCP requirements contained in Chapter 11 of this Part with a frequency goal of at least once each month.

4. Inspect each milk tank truck and its appurtenances at least once each 12 months.

5. Observe and evaluate the receiving and sampling procedures of each dairy plant receiver/sampler at least once each three months to determine compliance with applicable requirements.

6. Observe and evaluate the milk pickup and sampling procedures of each bulk milk tank truck operator/sampler at least once each 24 months to determine compliance with applicable requirements.

7. Inspect each dairy farm with a frequency at least as that required by the Performance-Based Inspection Program.

C. Performance-Based Inspection Program requirements:

1. A risk assessment shall be performed on each dairy farm once each month by evaluating the performance of the farm using the last standard plate count, somatic cell count, sanitation compliance score, sediment score, drug residue test, coliform count of the water supply and other areas of the operation related to product safety as the criteria for establishing the Inspectional Frequency Category for the dairy farm.

2. The state health officer shall inspect dairy farms in each category at a frequency not less than the following intervals:

a. category I: at least once each three months;

b. category II: at least once each two months;

c. category III: at least once each month; and,

d. category IV: within 21days of the last inspection but not before the lapse of three days.

3. The following criteria shall be used to categorize farms into the Inspection/Frequency Categories as defined below:

a. Category I (minimum of one inspection each three months):

i. standard plate count (SPC) not exceeding 10,000 cfu/milliliter (ml.);

ii. somatic cell count (SCC) not exceeding 250,000/ml;

iii. sanitation compliance score 97 percent - 100 percent;

iv. sediment not exceeding four;

v. no drug residue violations;

vi. no violation which may reasonably likely result in adulteration of

the milk supply or an imminent hazard to the public’s health; and,

vii. bacteriologically safe water supply.

b. Category II (minimum of one inspection each two months):

i. SPC 11,000 cfu/ml. - 50,000 cfu/ml;

ii. SCC 251,000/ml. - 500,000/ml;

iii. sanitation compliance score 93 percent - 96 percent;

iv. sediment not exceeding four;

v. no drug residue violations;

vi. no violation which may reasonably likely result in adulteration of the milk supply or an imminent hazard to the public’s health; and,

vii. bacteriologically safe water supply.

c. Category III (minimum of one inspection each month):

i. SPC 51,000 cfu/ml.100,000 cfu/ml;

ii. SCC 501,000/ml.750,000/ml;

iii. sanitation compliance score 90 percent92 percent;

iv. sediment not exceeding four;

v. no drug residue violations;

vi. no violation which may reasonably likely result in adulteration of the milk supply or an imminent hazard to the public’s health; and,

vii. bacteriologically safe water supply.

d. Category IV (inspect within 21days of the last inspection, but not before the lapse of three days):

i. SPC not exceeding 100,000 cfu/ml.;

ii. SCC not exceeding 750,000/ml.;

iii. sanitation compliance score less than 90 percent;

iv. sediment four;

v. one or more drug residue violation(s);

vi. one or more violation(s) that may reasonably likely result inadulteration of the milk supply or an imminent hazard to the public’s health;

vii. unsafe water supply.

viii. one or more warning letters issued due to non-compliance of two out of four previous sample results for SPC or SCC during last two months; and,

ix. farm conditions which caused the state health officer to take official regulatory action (i.e.; warning letter, intent to suspend, reinspection, etc).

4. When the risk assessment of a dairy farm indicates a category IV in one or more criteria the next inspection of the dairy farm should include:

a. an evaluation of the cleaning equipment and procedures when the SPC category is IV;

b. an evaluation of milking procedures and the environment of the areas of the farm in which the milking herd is kept when the SCC category is IV;

c. a conference with the owner/operator when the sanitation compliance score category is IV; and,

d. an evaluation of the milking procedures, milking equipment and the environment of the areas of the farm in which the milking herd is kept when the sediment category is IV.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7) (15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2652 (September 2011).

§313. Pasteurization Equipment Tests, Examinations and Sealing

A. The state health officer shall perform the tests using the methodology prescribed in the PMO on the instruments and devices of each pasteurizer in each dairy plant and frozen dessert manufacturing plant indicated in the table below initially upon installation; and at least once each three months, including the remaining days of the month in which the equipment tests are due and whenever any alteration or replacement is made which may affect the proper operation of the instrument or device. Provided, that the holding time test shall be conducted at least once each six months, including the remaining days of the month in which the equipment test is due. A copy of the test report shall be retained by the plant.

B. Plants being regulated under the provisions of Chapter 11 (Dairy Plant HACCP System) shall be responsible for the performance for all above required tests should the state health officer fail to perform them at the required frequency.

C. The state health officer shall affix regulatory seals to all pasteurization equipment, as prescribed by the PMO, after testing the equipment.

D. The state health officer shall provide the plant a copy of the pasteurization equipment test report.

E. The plant shall notify the state health officer immediately if the regulatory seals are broken.

F. The pasteurization equipment shall not be operated without authorization from the state health officer when any of the required regulatory seals are broken.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7) (15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2653 (September 2011).