Md. Code Regs. 10.15.09.02 - Definitions

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) "3-A Sanitary Standards" means the standards for dairy equipment and accepted practices formulated by the 3-A Sanitary Standards Committee representing the:

(a) American Dairy Products Institute;

(b) International Dairy Foods Association;

(c) Food Processing Suppliers Association; and

(d) International Association for Food Protection.

(2) "Agistment agreement" means the sale of shares or interest in a:

(a) Cow, goat, or other lactating hooved mammal; or

(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.

(6) "Bulk milk hauler/sampler " means an individual who:

(a) Collects official samples;

(b) Transports raw milk from a farm, or raw milk products to or from a:

(i) Milk plant;

(ii) Receiving station; or

(iii) Transfer station;

(c) Possesses a permit from any state to sample milk or raw milk products; and

(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.

(9) "Cheese" means the fresh or matured product that:

(a) Is obtained by draining after coagulation of milk, cream, skimmed or partly skimmed milk, or a combination of some or all of these products; and

(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 52°C (125°F) but less than 75°C (166°F), then immediately cooled to 7°C (45°F) 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 52°C (125°F) but less than 72°C (161°F), then immediately cooled to 7°C (45°F) 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.

(22) "Manufactured grade milk product" means:

(a) Butter;

(b) Cheese, natural or processed;

(c) Condensed skim milk, plain or sweetened;

(d) Condensed whole milk;

(e) Cream;

(f) Dry buttermilk;

(g) Dry whey;

(h) Dry whole milk;

(i) Evaporated milk, whole or skim;

(j) Nonfat dry milk;

(k) Quark; or

(I) 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 healthy hooved mammals.

(24) "Milkfacility" means a:

(a) Distribution station;

(b) Milk plant;

(c) Milk processor;

(d) Milk tank truck cleaning facility;

(e) Receiving station; or

(f) Transfer station.

(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.

(27) Milk Plant.

(a) "Milk plant" means a place where milk products are:

(i) Received and stored;

(ii) Processed;

(iii) Pasteurized;

(iv) Packaged; or

(v) Prepared for distribution.

(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.

(29) "Milk producer" means a person who:

(a) Operates a dairy farm; and

(b) Provides, sells, or offers milk for sale to a:

(i) Milk plant;

(ii) Receiving station; or

(iii) Transfer station.

(30) "Milkproduct" 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.

(36) Nonfat.

(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.

(38) "Officially designated laboratory" means a commercial laboratory authorized to conduct testing of milk and milk products on behalf of the Department or a milk industry laboratory officially designated by the Department for the examination, pursuant to the standards set forth in the Grade "A" Pasteurized Milk Ordinance, of

(a) Producer samples of Grade "A" raw milk for pasteurization; or

(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.

(40) "Pasteurization" means the process of heating every particle of milk or milk product, in approved and properly designed equipment, by:

(a) Heating the product to one of the following minimum temperatures and holding at this temperature continuously for at least the specified time:

(i) 63°C (145°F) for 30 minutes;

(ii) 72°C (161°F) for 15 seconds;

(iii) 89°C (191°F) for 1 second;

(iv) 90°C (194°F) for 0.5 seconds;

(v) 94°C (201°F) for 0.1 seconds;

(vi) 96°C (204°F) for 0.05 seconds; or

(vii) 100°C (212°F) for 0.01 seconds;

(b) For milk or milk products with fat content of 10 percent or greater, a total solids of 18 percent or greater, or containing added sweeteners, heating the product to one of the following minimum temperatures and holding at this temperature continuously for at least the specified time:

(i) 66°C (150°F) for 30 minutes;

(ii) 75°C (166°F) for 15 seconds; or

(iii) The temperatures and times listed in §B(34)(a)(iii)-(vii) of this regulation;

(c) For milk or milk products that the USDA requires a specific product pasteurization temperature for, heating the product to the temperature requirement outlined in the USDA Milk for Manufacturing Purposes and its Production and Processing, Recommend Requirements; or

(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.

(43) Person.

(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.

(b) "Person" includes:

(i) An operator of a facility that is owned by a State or local unit of government; or

(ii) A State or local unit of government if the State or local unit of government is the operator of the facility.

(44) "Raw milk" means unpasteurized milk, which includes:

(a) Heat treated nonfat skim milk;

(b) Heat treated reduced fat milk;

(c) Heat treated lowfat milk; and

(d) Heat treated cream.

(45) "Receiving station" means a place, premises, or establishment where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting.

(46) "Recombined" means that a milk or a milk product is made by combining water and nonfat dry milk solids with:

(a) Cream;

(b) Butterfat; or

(c) Milk fat.

(47) "Reconstituted" means that a milk or a milk product has resulted from either:

(a) Combining dry whole milk solids with the appropriate amount of water; or

(b) Adding water to evaporated milk.

(48) "Retort processed after packaging" means that the milk or milk product, or both, have been subjected to sufficient heat processing after being packaged in a hermetically sealed container, to:

(a) Conform with applicable requirements under 21 CFR Parts 108, 113, and 117; and

(b) Maintain commercial sterility of the milk or milk products under nonrefrigerated conditions.

(49) "Sale" means a transaction that involves the:

(a) Transfer, dispensing, or serving of milk and milk products with or without charge; or

(b) Right to acquire milk and milk products:

(i) Through barter or contractual arrangement; or

(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.

(54) Skim.

(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.

Notes

Md. Code Regs. 10.15.09.02

Regulation .02 adopted effective 46:10 Md. R. 485, eff. 5/20/2019