Source: https://health.maryland.gov/regs/Pages/10-15-09-Production,-Processing,-Transportation,-Storage,-and-Distribution-of-Manufactured-Grade-Milk-(PHPA).aspx
Timestamp: 2019-04-24 20:31:28+00:00

Document:
The Secretary of Health proposes to repeal existing Regulations .01—.20 and adopt new Regulations .01—.22 under COMAR 10.15.09 Production, Processing, Transportation, Storage, and Distribution of Manufactured Grade Milk.
The purpose of this action is to amend COMAR 10.15.09 in order to update language to match other similar regulations and to align with the most recent guidelines including the Federal Food, Drug, and Cosmetic Act; the Nutrition Labeling and Education Act of 1990; Evaluation of Milk Laboratories; the Bulk Milk Hauler/Sampler Manual; the Grade “A” Pasteurized Milk Ordinance; Milk for Manufacturing Purposes and its Production and Processing; the Maryland Laboratory Evaluation Program Manual; and Standard Methods for the Examination of Dairy Products, which are being added to the incorporation by reference regulation of this chapter. The proposal also phases in certain new requirements of the FDA Food Safety Modernization Act.
I. Summary of Economic Impact. These changes will not have an impact on the Maryland Department of Health, but will have an indeterminable economic impact on the regulated dairy industry. Some businesses may incur costs as a result of bringing their business practices into alignment with new requirements of the updated Food Safety Modernization Act.
D. This proposal will have an indeterminable economic impact on the regulated dairy industry. Some businesses may incur costs associated with changes that will bring their business practices into alignment with new requirements of the updated Food Safety Modernization Act. Some of these new requirements include conducting risk assessments, constructing a food safety plan, writing standard operating procedures, designing environmental sampling programs, and new ingredient requirements. Because of variations in current equipment and practices at each business, it is not possible to predict what the overall impact of these changes will be.
(2) Evaluation of Milk Laboratories, 2015 Revision.
For this reason, these documents will not be printed in the Maryland Register or the Code of Maryland Regulations (COMAR). Copies of these documents are filed in special public depositories located throughout the State. A list of these depositories was published in 46:1 Md. R. 9 (January 4, 2019), and is available online at www.dsd.state.md.us. These documents may also be inspected at the office of the Division of State Documents, 16 Francis Street, Annapolis, Maryland 21401.
(3) Regulates the inspection of manufactured grade dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products.
(5) Requirements for dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products.
A. In this chapter, the following terms have the meanings indicated.
(d) International Association for Food Protection.
(b) Herd of cows, goats, or other lactating hooved mammals.
(3) “Approved” means meeting the criteria set forth in this chapter.
(4) “Aseptic processing and packaging” means the filling of a commercially sterilized cooled product into pre-sterilized containers, followed by aseptic hermetical sealing, with a pre-sterilized closure, in an atmosphere free of microorganisms.
(5) “Bobtailer” means a person who operates or controls a manufactured milk product route and distributes a manufactured milk product that the person buys from a distributer or manufactured milk processor.
(d) If they are sampling raw milk in the State, possesses a Maryland Bulk Milk Hauler license.
(7) “Butter” means the food product that is made exclusively from milk or cream, or both, with or without salt, and with or without additional coloring matter, and that contains not less than 80 percent by weight of milk fat.
(8) “Certified industry dairy farm inspector” means a person who is certified by the Secretary under Health-General Article, §21-414, Annotated Code of Maryland, to perform as specified in that section.
(b) Meets the standards of identity in 21 CFR Part 133.
(10) “Commercial sterility” means the condition achieved by a treatment that renders equipment, containers, and food free of viable microorganisms that are capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.
(11) “Dairy farm” means a place where at least one cow, goat, or other hooved mammal is kept, and from which the milk from these animals is sold or offered for sale.
(12) “Dairy plant sampler” mean a person responsible for the collection of official samples for regulatory purposes outlined in Section 6 of the Pasteurized Milk Ordinance.
(13) “Department” means the Maryland Department of Health or its designee.
(14) “Departmental inspection area” means the area in which the Department routinely makes inspections, which consists of that area within the boundaries of Maryland and any other area as may be designated by the Secretary.
(15) “Distribution station” means a place or vehicle where, for redistribution and resale, a manufactured grade milk product routinely is received, stored, or transferred.
(16) “Distributor” means a person who offers for sale a manufactured grade milk product.
(17) “Heat treated cream” means milk that has been heated during separation to temperatures greater than 52ºC (125ºF) but less than 75ºC (166ºF), then immediately cooled to 7ºC (45ºF) or less for the purpose of producing and shipping cream for bulk shipments.
(18) “Heat treated milk” means milk that has been heated one time during separation to temperatures greater than 52ºC (125ºF) but less than 72ºC (161ºF), then immediately cooled to 7ºC (45ºF) or less for the purpose of producing and shipping heat treated nonfat skim milk, reduced fat milk, or lowfat milk for bulk shipments.
(19) “Industry plant sampler” means a person employed at a milk plant, a receiving station, or a transfer station who is responsible for the collection of official samples for regulatory purposes at the milk plant, receiving station, or transfer station.
(20) “Instant nonfat dry milk” means nonfat dry milk that has been produced in such a manner as to substantially improve its dispersing and reconstitution characteristics over that produced by the conventional processes.
(21) “Manufactured grade milk” means the milk of a cow, goat, or other hooved mammal that is produced, processed, pasteurized, packaged, or prepared for human consumption in accordance with the standards set forth in this chapter.
(l) Any other product made with manufactured grade milk that is regulated by the Department.
(23) “Milk” means the lacteal secretion of a cow, goat, or other hooved mammal, practically free from colostrum, obtained by the complete milking of one or more healthyhooved mammals.
(25) “Milk hauler” means an individual who is in charge of a milk tank truck while it is receiving, transporting, or delivering milk or a milk product.
(26) “Milk marketing agency” means a person who negotiates the price of milk to be offered for sale and supplies milk.
(b) “Milk plant” does not include a place where milk products are sold at retail only.
(28) “Milk processor” means a person who owns, operates, or controls a milk plant.
(30) “Milk product” means butter, cream, natural or processed cheese, dry milk or whey product, whole or skim evaporated milk, condensed whole milk, and plain or sweetened condensed skim milk, all of which are defined or described in this chapter, or at 21 CFR 131, 133, and 184, and any other product that may be developed and made from manufactured grade milk.
(31) “Milk tank truck” means a truck and its equipment that are used to transport milk or milk products.
(32) “Milk tank truck cleaning facility” means a place, premises, or establishment, separate from a milk plant, receiving station, or transfer station, where a milk tank truck is cleaned and sanitized.
(33) “Milk tank truck driver” means an individual who transports raw or pasteurized milk or milk products to or from a milk plant, receiving station, or transfer station and does not sample producer raw milk.
(34) “Milk transport container” means a vessel meeting 3-A Sanitary Standards or equivalent standards used by on-farm processors to transport milk from the dairy farm to the milk plant.
(35) “National Conference on Interstate Milk Shipments (NCIMS)” means a nonprofit organization made up of persons involved in the dairy industry, who make the laws governing all aspects of the milk sanitation program.
(a) “Nonfat” means a product contains less than 0.5 percent fat.
(b) “Nonfat” has the same meaning as skim or fat free.
(37) “Official laboratory” means a biological, chemical, or physical laboratory that is operated by the Department.
(b) Comingled milk tank truck samples of Grade “A” raw milk.
(39) “On-farm processor” means a licensed milk plant that is located on the same premises as a licensed milk producer.
(d) Utilizing another process found equivalent to pasteurization for milk and milk products, which has been recognized and approved by FDA as provided in the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §343(h)(3).
(41) “Permit” means an official document with a manufactured grade classification issued by the Secretary in accordance with Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, that authorizes the holder of the permit to do an act that is within the scope of the permit.
(42) “Permittee” means a person who holds a permit as defined in this chapter.
(a) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.
(ii) A State or local unit of government if the State or local unit of government is the operator of the facility.
(45) “Receiving station” means a place, premises, or establishment where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting.
(b) Adding water to evaporated milk.
(b) Maintain commercial sterility of the milk or milk products under nonrefrigerated conditions.
(ii) In exchange for another form of compensation including, but not limited to, an agistment agreement.
(50) “Sanitization” means the application of an effective method or substance to clean surfaces to destroy pathogens and other microorganisms that does not damage the surface or adversely affect the milk or milk product that may come into contact with the surface.
(51) “Seasonal milk producer” means a milk producer that holds a permit to produce milk seasonally and stops producing milk for 30 days or more and then starts producing milk again within 12 months year after year.
(52) “Secretary” means the Secretary of Health or the Secretary’s designee.
(53) “Sell” means to offer for sale.
(a) “Skim” means a product contains less than 0.5 percent fat.
(b) “Skim” has the same meaning as nonfat or fat free.
(55) “Transfer station” means a place, premises, or establishment where milk or milk products are transferred directly from one milk tank truck to another.
(56) “Whey” means the liquid substance obtained by separating the coagulum from milk, cream, or nonfat milk in cheese making that meets the requirements of 21 CFR §184.1979.
M. Standard Methods for the Examination of Dairy Products (American Public Health Association, Seventeenth Edition, 2004).
(8) Beginning January 1, 2019, FDA Food Safety Modernization Act, 21 U.S.C. §§2201—2252, as amended.
B. A person engaged in an occupation involving manufactured grade milk and milk products shall conduct all activities as set forth in and in compliance with the standards, requirements, and procedures specified in §A of this regulation.
B. Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17 for a milk tank truck.
(1) When issued a permit, a permittee shall supply and display a decal.
(b) The words “MD Milk Trans.” in a circle around the permit number.
(3) The permittee’s decal shall be displayed on the rear tank of each milk tank truck.
(4) An individual who only transports milk in a sealed tanker to a milk plant.
(6) Collect official milk samples.
(3) Be an employee of a milk transportation company, if applying for a Maryland Bulk Milk Hauler license, or be an owner of a milk transportation company, if applying for a Milk Transportation Company permit.
(2) Meets the requirements of this chapter for each place of operation.
(2) Is not valid if there is a change of owner, corporation, partnership, or physical location.
(3) A statement concerning the number of Maryland dairy farms from which the bulk milk hauler/sampler will pick up.
F. A bulk milk hauler/sampler who holds a permit from another state may pick up and sample raw milk from no more than three Maryland farms without a Maryland field evaluation or written exam.
G. If a bulk milk hauler/sampler who holds a permit from another state routinely picks up and samples raw milk at three or more Maryland farms, a Maryland field evaluation shall be conducted.
.07 Sale of Raw Milk.
A. Under Health-General Article, §21-434, Annotated Code of Maryland, a person may not sell or give away raw milk for human consumption.
.08 Standards for Milk for Manufacturing Purposes.
(2) Testing required for raw milk for pasteurization, pasteurized milk products, and dairy product containers and lids is performed according to the requirements established by the Maryland Laboratory Evaluation Program Manual.
Bulk cooled to 10ºC (50ºF) or less within 4 hours or less of the commencement of the first milking, and to 7°C (45ºF) or less with­in 2 hours after the completion of milking. Pro­vided that the blend temperature after the first milking and subsequent milkings does not exceed 10ºC (50ºF). Milk transported in cans maintained at 7ºC (45ºF) or less. Note: Milk sample submitted for testing cooled and maintained at 0ºC (32ºF) to 4.5ºC (40ºF), where sample temperature is greater than 4.5 ºC (40ºF), but less than or equal to 7.0ºC (45oF) and less than 3 hours after collection has not increased in temperature.
Individual producer milk not to exceed 500,000 per mL before commingling with other producer milk.
Not to exceed 1,000,000 per mL as com­mingl­ed milk before pas­teurization.
Note: Tested in conjunction with the drug residue test.
No positive results on drug residue detection methods as referenced in Grade “A” Pasteurized Milk Ordinance, Section 6 — Laboratory Techniques.
Individual producer milk not to exceed 750,000 per mL except for individual producer goat milk, which is not to exceed 1,500,000 per mL.
Has normal odor and appearance. Free from excessive coarse sediment visually. Milk may not show any abnormal condition (such as, but not limited to curded, ropy, bloody, or mastitic) as indicated by sight or test procedures.
The odor shall be fresh, sweet, and free from objectionable feed or other off odors that adversely affect the finished product.
Less than or equal to 10/gram, or less than or equal to 100/gram in the case of bulk transport tank shipments.
.09 Inspection and Evaluation of Milk Production, Milk Processing, and Milk Transportation.
B. The Secretary shall inspect a distribution station at least once every 6 months.
C. The Secretary shall inspect a bobtailer at least once every 12 months.
D. The Secretary shall inspect a seasonal milk producer before the first shipment of milk and at least every 6 months until milk production for sale has ceased.
E. Under the standards set forth in Health-General Article, §21-809, Annotated Code of Maryland, and the Grade “A” Pasteurized Milk Ordinance Item 16p.(D)2, the Secretary shall perform equipment tests and examinations at least once every 3 months.
F. The Secretary shall inspect a milk plant without a pasteurizer at least once every 6 months.
(3) Sampling procedures of the industry plant sampler.
H. The Secretary shall inspect and evaluate the bulk milk hauler/sampler as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 5 and Appendix B, Sections I through III.
I. The Secretary shall inspect each milk tank truck as set forth in the Grade “A” Pasteurized Milk Ordinance, Appendix B, Section IV.
(3) Laboratory analyst performing required testing.
(1) If an inspection discloses the existence of a violation of a requirement set forth in this chapter, the Secretary shall re-inspect within 30 days, but not before 3 days, to determine compliance with the requirements of Regulation .13 of this chapter.
(2) If the Secretary finds on the second inspection a violation of the same requirement in this chapter, the Secretary shall issue a notice of intent to suspend the permit.
(3) If the Secretary finds a violation of the same requirement as specified on the notice of intent to suspend the permit on an inspection following the date of compliance as specified in the notice of intent to suspend the permit, the Secretary shall suspend the permit in accordance with Regulation .21 of this chapter and Health-General Article, §§21-418 and 21-419, Annotated Code of Maryland, or initiate appropriate court action.
(b) Post the inspection report in a conspicuous place on an inside wall of the establishment immediately after the conclusion of the inspection.
(2) The permittee may not deface the inspection report and shall make the inspection report available to the Department upon request.
(3) The Secretary shall keep a copy of the inspection report on file for 3 years.
M. Access Required. Upon request of the Secretary, a milk producer, milk hauler, distributor, milk processor, receiving station operator, transfer station operator, or bobtailer shall permit the Secretary access to all parts of the milk establishment, facility, or transporting vehicle to determine compliance with the provisions of this chapter and Health-General Article, Title 21, Subtitles 2 and 4, Annotated Code of Maryland.
(3) Records of inspections, tests, and pasteurization times and temperatures.
(4) A certified Industry Dairy Farm Inspector.
B. An individual collecting official milk samples shall collect samples in accordance with the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix B.
C. The Secretary shall evaluate the sampling and examination procedures of manufactured grade milk and milk products to ensure that the sampling and examination procedures are conducted according to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix B.
D. Can milk shall be sampled and analyzed in accordance with Milk for Manufacturing Purpose and Processing, Section C12(2)(ii) and C12(3)(ii).
(3) When a repair or alteration of the water supply system has been made.
F. The Secretary shall record and retain for at least 5 years all sample analysis results required under this regulation.
.11 Additional Requirements for Transporting of Manufactured Grade Milk.
(7) In accordance with Standard Methods for the Examination of Dairy Products, 3.042, A, ensure proper agitation of the farm bulk tank raw milk.
(4) In a milk plant.
C. Vehicles used for the transportation of can milk or cream shall be enclosed and constructed to protect the product from extreme temperature, dust, or other adverse conditions.
D. Stainless steel cans used in transporting milk from the dairy farm to a milk facility shall be constructed according to 3-A Sanitary Standards.
E. Milk transport containers used in transporting milk from the dairy farm to a milk facility shall be approved by the Secretary.
F. Vehicles used for the transportation of milk from the dairy farms to a milk facility may not be used for any other purpose.
G. Vehicles used for the transportation of milk shall be equipped with decking boards or racks when more than one tier of milk containers are carried.
H. The milk tank truck driver shall take responsibility for any official samples that may accompany the milk tank truck.
.12 Improper Handling of Milk Products.
A. Under Health-General Article, §21-428, Annotated Code of Maryland, the Secretary shall impound improperly handled milk or milk products that are intended for human consumption.
(3) Under Health-General Article, §21-428, Annotated Code of Maryland, imposing a civil monetary penalty, as set forth in §C of this regulation.
C. The Secretary shall determine the amount of the civil monetary penalty by multiplying the current milk price, as announced by the Federal Milk Market Administrator, on the date of the impounding by the volume of the milk listed on the shipping documents.
(2) Bringing an action for damages.
(5) Health-General Article, §§21-422, 21-424, and 21-425, Annotated Code of Maryland.
(11) The word “Heat-Treated” for heat-treated milk and milk products.
C. A milk producer shall label all cans of raw milk from the producer’s dairy farm with the milk producer’s name or permit number.
All raw milk and milk products produced, processed, packaged, and stored under this chapter shall meet the Animal Health requirements as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 8.
.15 Dairy Farm Construction and Plan Submission.
(4) Pre-cooler type and British thermal units capability, if applicable.
(7) Water supply and its distribution system.
(7) Electrical systems and lighting requirements comply with State and local electrical laws, ordinances, and regulations, and the Grade “A” Pasteurized Milk Ordinance.
.17 Milk Facility Construction and Plan Submission.
(5) Written verification procedures as appropriate to the nature of the preventative control and its role in the facility’s food safety system.
.18 Milk Physical Plant Requirements.
(5) Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system.
(3) A sanitary means of drying hands, such as individual towels or a hand-drying device.
C. A sewage system shall be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance.
D. Plumbing shall be sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations.
(d) Have documentation from the local approval authority that an on-site sewage disposal system, if present, is adequate for the total number of users and meets all other requirements of 26.04.02.
(3) Provide adequate lighting sources that furnish at least 20 foot-candles of light in dry storage and cold storage rooms.
A. An applicant may not construct, reconstruct, or extensively alter a plant without prior plan approval from the Department.
(2) Regulations .17 and .18 of this chapter for a milk facilities permit.
(d) Of the appeals process if the plan is denied.
The Department shall maintain confidentiality of records submitted by a person in accordance with General Provisions Article, §4-335, Annotated Code of Maryland.
.21 Suspension and Revocation of Permits.
A. When a permittee is found in violation of this chapter and the Grade “A” Pasteurized Milk Ordinance, the Secretary may suspend or revoke a permit as set forth in this regulation and Health-General Article, §§21-211, 21-418, or 21-419, Annotated Code of Maryland, or the Grade “A” Pasteurized Milk Ordinance.
B. Except as otherwise provided in this regulation, before suspending a permit, the Secretary shall give to the permittee notice of intent to suspend as provided by Health-General Article, §21-418, Annotated Code of Maryland.
C. The Department may suspend a permit if the permittee fails or neglects to correct a violation within the specified time period.
D. If a permit has been suspended more than once, the Secretary may revoke the permit.
E. The Department shall ensure that an opportunity for a hearing is provided to a person whose permit has been suspended or revoked.

References: §21
 §343
 §184
 §21
 §21
 §21
 §21
 §4
 §21