2 Va. Admin. Code § 5-531-50

Current through Register Vol. 41, No. 8, December 2, 2024

Section 2VAC5-531-50 - Permits

A. No person may produce, provide, sell, offer for sale, or store in the Commonwealth of Virginia, or bring, send, or receive into the Commonwealth of Virginia, any milk for manufacturing purposes unless the person possesses a permit from the Virginia Department of Agriculture and Consumer Services.

B. No person may produce, process, manufacture, handle, package, reprocess, repackage, rework, offer for sale or sell any manufactured dairy product in the Commonwealth of Virginia unless the person possesses a permit from the Virginia Department of Agriculture and Consumer Services. The requirement for a permit shall not apply to (i) any person's establishment where a manufactured dairy product is served or sold at retail, so long as the manufactured dairy product is not produced, manufactured, reprocessed or reworked at the establishment; (ii) any person who distributes and does not process manufactured dairy product; or (iii) any person producing manufactured dairy product outside the Commonwealth of Virginia.

C. The Virginia Department of Agriculture and Consumer Services may cancel, suspend, or revoke the permit of any person, or may deny to any person a permit if:

1. The permit holder fails to engage daily in the business for which the permit is issued;

2. The permit holder does not daily produce, provide, manufacture, sell, offer for sale, or store in the Commonwealth of Virginia milk for manufacturing purposes or dairy product;

3. The permit holder fails to provide at no cost to the Virginia Department of Agriculture and Consumer Services samples of milk for manufacturing purposes or dairy product in the person's possession for testing by the Virginia Department of Agriculture and Consumer Services;

4. The permit holder fails to provide on a daily basis milk for manufacturing purposes or dairy product in the person's possession for sampling and testing by the Virginia Department of Agriculture and Consumer Services;

5. The permit holder fails to comply with any requirement of this chapter, or of Article 1 (§ 3.2-5200 et seq.), Article 2 (§ 3.2-5206 et seq.), and Article 4 (§ 3.2-5218 et seq.) of Chapter 52 of Title 3.2 of the Code of Virginia;

6. A public health hazard exists that affects the permit holder's milk for manufacturing purposes or dairy product;

7. The permit holder or any agent of the permit holder has obstructed or interfered with the Virginia Department of Agriculture and Consumer Services in the performance of its duties;

8. The permit holder or any agent of the permit holder knowingly supplies false or misleading information to the Virginia Department of Agriculture and Consumer Services (i) in the permit holder's application for a permit; (ii) concerning the identity of the person or persons who will control the facility that is the subject of the permit; (iii) concerning the amount of milk for manufacturing purposes or dairy product which the permit holder produces, provides, manufactures, sells, offers for sale, or stores in the Commonwealth of Virginia, or brings, sends, or receives into the Commonwealth of Virginia and the distribution of the permit holder's milk for manufacturing purposes or dairy product; (iv) concerning any investigation conducted by the Virginia Department of Agriculture and Consumer Services; or (v) concerning the location of any part of the permit holder's operation that is subject to a permit;

9. The permit holder engages in fraudulent activity regarding (i) the amount of milk for manufacturing purposes or dairy product the permit holder offers to sell or sells; or (ii) the collection of samples of the permit holder's milk for manufacturing purposes or dairy product used to determine compliance with any provision of this chapter or as a basis for payment for milk for manufacturing purposes or dairy product.

10. Three of the most recent five bacteria counts, somatic cell counts, or cooling temperature determinations conducted on the permit holder's raw milk for manufacturing purposes exceed the standards specified in this chapter;

11. Three of the most recent five bacteria counts, coliform determinations, or cooling temperature determinations conducted on the permit holder's milk for manufacturing purposes or dairy product exceed the standards specified in this chapter;

12. The most recent drug residue test on the permit holder's milk for manufacturing purposes or dairy product violates the standard specified in this chapter;

13. The most recent phosphatase test on the permit holder's dairy product violates the standard specified in this chapter;

14. The most recent chemical residue test or pesticide residue test on the permit holder's milk for manufacturing purposes or dairy product exceeds the actionable level, tolerance level, or safe level for any chemical residue or pesticide residue specified in 40 CFR Parts 180, 185, or 186 and 21 CFR Parts 70, 71, 73, 74, 80, 82, 130, 131, 133, 170, 172, 173, 174, 175, 176, 177, 178, 189, 556, 564, 570, 573, 589. In the event that no actionable level, tolerance level, or safe level for a chemical residue or pesticides residue has been established in 40 CFR Parts 180, 185, or 186 and 21 CFR Parts 70, 71, 73, 74, 80, 82, 130, 131, 133, 170, 172, 173, 174, 175, 176, 177, 178, 189, 556, 564, 570, 573, 589, the tolerance level shall be deemed to be zero;

15. The permit holder fails to correct any deficiency that the Virginia Department of Agriculture and Consumer Services has cited in a written notice of intent to suspend the permit holder's permit, as a violation of this chapter;

16. The permit holder's raw milk for manufacturing purposes is warmer than 50°F two hours after the completion of the first milking or the permit holder's raw milk for manufacturing purposes is warmer than 50°F during or after any subsequent milking;

17. The dairy farm permit holder's raw milk for manufacturing purposes is older than 76 hours;

18. The permit holder's equipment is covered or partially covered by an accumulation of milk solids, milkfat, or other residue;

19. The permit holder sells or offers for sale milk for manufacturing purposes or dairy product which violates any requirement of this chapter;

20. The permit holder's permit is suspended three times within a 12-month period for violation of the bacteria, coliform, cooling temperature, somatic cell, drug residue, maximum length of time for milk storage on the farm, phosphatase, chemical residue, pesticide residue standards, or other requirements specified in this chapter;

21. The authority in another state responsible for issuing permits has denied, suspended, or revoked the permit of the person in that state for any act or omission that would violate this chapter or the statutes under which this chapter was adopted, had the act or omission occurred in the Commonwealth of Virginia;

22. The Virginia Department of Agriculture and Consumer Services has previously revoked the person's permit to produce, provide, sell, offer for sale, or store in the Commonwealth of Virginia, or bring, send, or receive into the Commonwealth of Virginia, any milk for manufacturing purposes;

23. The Virginia Department of Agriculture and Consumer Services has previously revoked the person's permit to produce, process, manufacture, handle, package, reprocess, repackage, or rework, and offer for sale or sell any manufactured dairy product in the Commonwealth of Virginia;

24. The most recent coliform count on the permit holder's cheese violates the standard specified in this chapter; and

25. The most recent Staphylococcus aureus count on the permit holder's cheese violates the standard specified in this chapter.

D. The Virginia Department of Agriculture and Consumer Services may summarily suspend a permit for violation of any of the following subdivisions of subsection C of this section: 6, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 24, or 25.

E. The Virginia Department of Agriculture and Consumer Services may suspend from sale any dairy product in violation of the requirements of this chapter processed by any dairy plant permit holder in lieu of suspending the dairy plant permit holder's permit.

F. If the Virginia Department of Agriculture and Consumer Services suspends a permit holder's permit more than three times within any 12-month period, the permit holder's permit shall not be reinstated for a period of three days on the fourth suspension within any 12-month period and six days on the fifth suspension within any 12-month period with three days being added to the required suspension period for each additional suspension thereafter.

G. If the Virginia Department of Agriculture and Consumer Services issues two written notices of intent to suspend a person's permit for failure to correct the same deficiency within any 12-month period, the Virginia Department of Agriculture and Consumer Services may issue and enforce a third written notice of intent to summarily suspend the person's permit at anytime within six months from the date of the third written notice if the same deficiency is found to exist on any inspection during the six months specified in the third written notice.

H. No permit holder may transfer any permit to another person or another location and no permit holder who has had their permit revoked by the Virginia Department of Agriculture and Consumer Services shall be eligible to hold a permit to produce milk for manufacturing purposes or a permit to operate a dairy plant at any time after the permit holder's permit is revoked.

I. Inspection of dairy farms and dairy plants.

1. No person who operates a dairy farm or dairy plant within the Commonwealth of Virginia may hold a permit until the dairy farm or dairy plant has been inspected and approved by the Virginia Department of Agriculture and Consumer Services;

2. Pasteurization equipment may be inspected and tested by any person who has demonstrated the knowledge, skills, and abilities to perform pasteurization inspections and been approved by the Virginia Department of Agriculture and Consumer Services to conduct inspections of vat pasteurizers or high temperature short time pasteurizers or both vat pasteurizers and high temperature short time pasteurizers. The Virginia Department of Agriculture and Consumer Services shall issue to all persons approved to inspect pasteurization equipment a letter of certification which shall expire 12 months from the date of issue unless renewed. The Virginia Department of Agriculture and Consumer Services may suspend the certification of any person who has been approved to inspect pasteurization equipment if the person fails to conduct the inspections and tests in accordance with the department's established policy and procedures for inspection of pasteurization equipment.

J. The examination of milk and dairy products.

1. The Virginia Department of Agriculture and Consumer Services shall collect during any consecutive six months at least four samples of raw milk for manufacturing purposes from each dairy farm that holds a permit, collected in at least four different months, except when three months show a month containing two sampling dates separated by at least 20 days. In the event the milk from a permitted dairy farm is picked up and delivered to a dairy plant which is located outside the Commonwealth of Virginia more than three times in any calendar month, the permit holder's milk marketing cooperative, broker, or person purchasing the permit holder's milk shall be responsible to ensure the appropriate number of samples and tests are performed in Interstate Milk Shipper approved laboratories and to supply the following information for each permit holder's milk samples to the Virginia Department of Agriculture and Consumer Services at no cost:

a. The name of the producer;

b. The patron number of the producer;

c. The name of the sampling operator;

d. The name of the person who collected the sample;

e. The location where the sample was received;

f. The date the sample was received;

g. The date, time, and temperature of the sample at time of collection;

h. The name of the test performed for each test result;

i. The reported laboratory result for each test performed; and

j. The name and address of the laboratory performing the testing.

2. The Virginia Department of Agriculture and Consumer Services shall collect samples of raw milk for manufacturing purposes for testing and analysis from each dairy farm holding a permit as it deems necessary.

3. The Virginia Department of Agriculture and Consumer Services shall collect samples of processed dairy products and ingredients for testing and analysis from each dairy plant holding a permit as it deems necessary.

K. Each permit holder operating a dairy plant shall develop a recall plan that when implemented will effectively carry out his responsibility to protect the public health and well-being from milk and dairy products that present a risk of illness, injury, gross deception, or are otherwise defective. Each permit holder operating a dairy plant shall submit his recall plan for approval to the Virginia Department of Agriculture and Consumer Services prior to the issuance of any dairy plant permit. The Virginia Department of Agriculture and Consumer Services shall review and approve the recall plan or require the recall plan to be modified by the permit holder operating a dairy plant. Each approved recall plan shall be reviewed annually and whenever new products are introduced by the permit holder operating a dairy plant. Each permit holder operating a dairy plant shall modify his recall plan based on his review and forward the revised plan to the Virginia Department of Agriculture and Consumer Services for approval within 60 days after the completion of any review that requires the recall plan to be modified. Each recall plan shall include provisions to provide the following information to the Virginia Department of Agriculture and Consumer Services:

1. Identity of the product involved;

2. Reason for the recall and the date and circumstances under which the product deficiency or possible deficiency was discovered;

3. Evaluation of the risk associated with the deficiency or possible deficiency;

4. Total amount of identified products produced and the time span of the production;

5. Total amount of identified products estimated to be in distribution channels;

6. Distribution information, including the number and identity of each person dairy products are sold to;

7. Draft copy of the permit holder's proposed recall communication;

8. Proposed strategy for conducting the recall; and

9. Name and telephone number of the permit holder's representative who should be contacted concerning the recall.

L. Each permit holder operating a dairy plant shall promptly notify each of its affected direct accounts about the recall and shall prepare the recall communication to:

1. Identify clearly the product, size, lot number(s), code(s) or serial number(s) and any other descriptive information to enable accurate and immediate identification of the product;

2. Explain concisely the reason for the recall and the hazard involved, if any;

3. Provide specific instructions on what should be done with respect to the recalled product;

4. Provide a ready means for the recipient of the communication to report to the recalling firm whether it has any of the product;

5. State that further distribution or use of any remaining product should cease immediately; and

6. Where appropriate, state that the direct account should in turn notify its customers who received the product about the recall.

M. Each permit holder operating a dairy plant shall provide to the Virginia Department of Agriculture and Consumer Services recall status reports as requested by the Virginia Department of Agriculture and Consumer Services until the recall is terminated. Each permit holder operating a dairy plant shall include in each recall status report the following information:

1. Number of consignees notified of the recall, and date and method of notification;

2. Number of consignees responding to the recall communication and quantity of products on hand at the time the recall communication was received;

3. Number and identity of consignees that did not respond to the recall communication;

4. Number of products returned or corrected by each consignee contacted and the quantity of products accounted for;

5. Number and results of effectiveness checks that were made; and

6. Estimated time frames for completion of the recall.

N. Each permit holder operating a dairy plant shall implement his recall plan within eight hours after receipt of written notification to do so by the Virginia Department of Agriculture and Consumer Services. In the event that the permit holder operating a dairy plant fails to implement his recall plan within eight hours after being notified to do so by the Virginia Department of Agriculture and Consumer Services, the department may prepare and issue the recall communication.

O. Drug residue monitoring and farm surveillance.

1. Each permit holder operating a dairy plant shall:

a. Test all milk that the plant receives for residues of beta lactam drugs using a test from Beta Lactam and Other Test Methods for Use Under Appendix N and Section 6 of the Grade "A" Pasteurized Milk Ordinance prior to processing any of the milk. Each permit holder shall test each bulk milk shipment using a sample collected from each tank truck after its arrival at the plant and prior to any further commingling. Each permit holder shall test each compartment from tank trucks with more than one compartment separately. Each permit holder shall test milk in cans using a sample formed separately at the receiving plant for each can milk producer included in the delivery, and the milk sample shall be representative of all milk received from each producer. Each permit holder operating a dairy plant which is classified as a producer/processor shall test for residues of beta lactam drugs in all milk that the dairy plant produces or receives for processing according to the requirements for sampling and testing bulk milk shipments and milk in cans stated in this subdivision;

b. Test each shipment of milk received for processing by screening test methods which have been Association of Official Analytical Chemists-(AO AC)-reviewed and Food and Drug Administration-(FDA)-accepted. In the event there are no AOAC reviewed and FDA accepted screening test methods for cow's milk, goat's milk, sheep's milk, water buffalo's milk, or milk from other mammals, the permit holder shall test for residues of beta lactam drugs with a screening test kit approved by the Virginia Department of Agriculture and Consumer Services. In lieu of any test specified in this subdivision O 1 b a permit holder may use AOAC first-action and AOAC final-action tests methods. Nothing in this subdivision O 1 b shall be deemed to include individual raw milk samples collected from each dairy farm included in any shipment of bulk tank raw milk for processing if the shipment of bulk tank raw milk for processing tests negative for animal drug residues;

c. Implement a random-sampling program when the commissioner of the FDA determines that a potential problem exists with animal drug residues or other contaminants in the milk supply. Each permit holder operating a dairy plant shall analyze the samples for the contaminant by a method determined by FDA to be effective in determining compliance with actionable levels or established tolerances. Each permit holder operating a dairy plant shall continue the random-sampling program until such time that the commissioner of the FDA is reasonably assured that the problem has been corrected. The sampling program shall represent and include during any consecutive six months, at least four samples collected in at least four separate months;

d. Retain each sample found to be positive for drug residues for a period of 120 hours after the sample test result is positive for drug residues for the use of the Virginia Department of Agriculture and Consumer Services unless directed otherwise by a representative of the Virginia Department of Agriculture and Consumer Services;

e. Abstain from selling or offering for sale any dairy product processed from milk received before results of drug screening tests are available and from milk which later tests positive for drug residues. All the permit holder's milk commingled with any milk which tests positive for drug residues shall be deemed adulterated. Each permit holder operating a dairy plant shall report to the Virginia Department of Agriculture and Consumer Services instances of adulteration within one hour after testing reveals the milk is adulterated with animal drug residues;

f. Record the results of tests on samples of raw milk and retain such records for a period of 12 months, report records of all results of tests on samples of raw milk to the Virginia Department of Agriculture and Consumer Services by the fifteenth day of each month for the preceding month, and maintain and make available to the Virginia Department of Agriculture and Consumer Services for inspection and review at the permitted facility records of results of tests on samples of raw milk. Each record of results of tests on samples of raw milk required by this subdivision shall include:

(1) The analyst's signature, date, time, and place where the test was performed;

(2) The registration identification of each pickup tanker of bulk raw milk or raw milk sampled;

(3) The test method used;

(4) The Interstate Milk Shipper Bulk Tank Unit identification number for each Grade A milk supply included on each pickup tanker of bulk raw milk tested if the milk is Grade A; and

(5) A statement whether the test results were positive or negative. If the results were positive, the permit holder shall also record:

(a) The identity of each producer contributing to the load from which the positive sample of raw milk was taken;

(b) The name of the person notified at the Virginia Department of Agriculture and Consumer Services of the positive test results;

(c) The date and time of day the person at the Virginia Department of Agriculture and Consumer Services was notified of the positive test results; and

(d) The method of notification of the Virginia Department of Agriculture and Consumer Services;

g. Immediately notify the Virginia Department of Agriculture and Consumer Services of any shipment of milk for processing when the shipment of milk is found to be positive for drug residues;

h. Test each producer sample of milk using a test from Drug Residue Test Methods for Confirmation of Presumptive Positive Results and Initial Producer Trace Back to determine the farm of origin, represented by each sample of milk which tests positive for drug residues, and immediately report to the Virginia Department of Agriculture and Consumer Services the result of each producer sample representing the raw milk for manufacturing purposes found to be positive for drug residues;

i. Provide by facsimile machine or email to the Virginia Department of Agriculture and Consumer Services copies of load manifests, producer weight tickets, laboratory worksheets where the results of laboratory tests are originally recorded, and records from electronic readers documenting the results for samples tested for all positive loads; and

j. Immediately discontinue receiving shipments of raw milk from the permit holder whose milk tests positive for drug residues until subsequent tests approved by the Virginia Department of Agriculture and Consumer Services are no longer positive for drug residues;

2. Each permit holder whose milk tests positive for drug residues shall dispose of such milk in a manner that removes it from the human food chain or in any manner approved by the Food and Drug Administration; and

3. Each permit holder operating a dairy plant that receives any milk that could require load confirmation or producer traceback as a result of a positive animal drug residue on a load of milk delivered at the plant shall provide to the Virginia Department of Agriculture and Consumer Services results of animal drug-residue tests from an officially designated laboratory. Each officially designated laboratory shall be listed in the IMS List-Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers as an approved milk laboratory certified to test load and producer samples. All laboratory results from officially designated laboratories shall be reported to the Virginia Department of Agriculture and Consumer Services within six hours of the initial presumptive positive result at the plant.

P. Each officially designated laboratory shall comply with the requirements for certification and listing contained in the Evaluation of Milk Laboratories, 2011 revision.

Q. Each permit holder who operates a dairy plant and each person who distributes dairy products shall furnish the Virginia Department of Agriculture and Consumer Services upon request:

1. A statement of the quantities of milk and dairy products purchased or sold by the dairy plant or distributor; and

2. A list of all sources from which the dairy plant or distributor received any milk or dairy product.

R. No person holding a permit to produce milk for manufacturing purposes may operate a dairy farm that receives on the dairy farm raw or untreated sewage or septage from any source.

S. No person holding a permit to produce milk for manufacturing purposes shall feed their lactating cows, goats, sheep, water buffalo, or other mammals any unprocessed poultry litter or other unprocessed body discharges from any animal.

T. No person holding a permit to produce milk for manufacturing purposes may place or hold in his milk storage tank any milk except that milk that was obtained from cows, goats, sheep, water buffalo, or other mammals milked at the permit holder's dairy farm; any milk that did not enter the milk storage tank through the milking and milk-handling equipment on the permit holder's dairy farm during the milking of the permit holder's cows, goats, sheep, water buffalo or other mammals; any milk that has been held without refrigeration; or any milk that has been exposed to chemical or physical contamination.

U. No person holding a permit to produce milk for manufacturing purposes may provide their milking cows, goats, sheep, water buffalo, or other mammals any feed separately or in combination that contains an aflatoxin residue greater than 20 parts per billion.

V. No person holding a permit to produce milk for manufacturing purposes may sell or offer for sale any milk for manufacturing purposes if it contains an aflatoxin residue equal to or greater than 0.50 parts per billion.

W. No person may hold a permit to produce milk for manufacturing purposes if any part of their facilities, equipment, storage, or processing area (except toilet rooms), requiring inspection is accessed through any room used for domestic purposes or part of any room used for domestic purposes. Toilet rooms used for domestic purposes shall be approved as complying with the requirements of this chapter only if (i) the toilet room is located within 300 feet of the milking barn, milking parlor, or milk room and (ii) all labor utilized in the milkroom, milking parlor or milking barn, and animal housing areas is provided by members of the permit holder's immediate family.

X. No person may hold a permit to produce, process, manufacture, handle, package, reprocess, repackage, or rework, and offer for sale or sell any manufactured dairy product in the Commonwealth of Virginia if any part of his facilities, equipment, storage, or processing area (except toilet rooms), requiring inspection is accessed through any room used for domestic purposes or part of any room used for domestic purposes. Toilet rooms used for domestic purposes shall be approved as complying with the requirements of this chapter only if (i) the toilet room is located within 300 feet of the processing facilities and (ii) all labor utilized in the processing facilities is provided by members of the permit holder's immediate family.

Y. Each person who holds a permit to produce milk for manufacturing purposes or a permit to operate a dairy plant and who freezes and stores any milk for use in the production of any dairy product shall:

1. Cool each day's morning milking to 40°F or cooler, without freezing, within two hours after milking;

2. Abstain from freezing each day's morning milking until completion of the same day's evening milking;

3. Freeze the milk from each milking or each day separately, in single-use, food-grade, plastic bags or other suitable food grade disposable containers;

4. Identify each single-use, food-grade, plastic bag or other suitable food-grade disposable container containing any frozen milk with the date it was produced, the number of milkings, the number of containers in the lot, the permit number of the dairy farm or dairy plant, and the name of the person who packaged and froze the milk;

5. Cool and store all frozen containers of milk at a temperature of 0°F or below until ready for use;

6. Thaw each container of frozen milk prior to use in a refrigerator adjusted to a maximum temperature of 40°F or thaw each container of frozen milk within two hours using a cool water bath;

7. Abstain from re-using any single-use, food grade, plastic bag or other suitable food-grade disposable container; and

8. Protect from contamination the frozen milk in each single-use, food-grade, plastic bag or other suitable food-grade disposable container during the thawing process.

2 Va. Admin. Code § 5-531-50

Derived from Virginia Register Volume 21, Issue 8, eff. January 26, 2005; amended, Virginia Register Volume 24, Issue 16, eff. May 29, 2008; Amended, Virginia Register Volume 32, Issue 03, eff. 11/19/2015.

Statutory Authority: § 3.2-5206 of the Code of Virginia.