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<chapter num="06" heading="Production, Processing, Transportation, Storage, and Distribution of Grade “A” Milk" title_num="10" subtitle_num="15">
  <regulation prefix="Regulation" num=".01" heading="Scope.">
    <text>This chapter:</text>
    <paragraph num="A.">
      <text>Governs permits for the sale of Grade “A” milk and milk products, as set forth in Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Requires a permit for the sale of Grade “A” milk and milk products;</text>
    </paragraph>
    <paragraph num="C.">
      <text>Regulates the inspection of Grade “A” dairy farms and milk facilities that produce, process, transport, store, or distribute Grade “A” milk or milk products; and</text>
    </paragraph>
    <paragraph num="D.">
      <text>Sets forth:</text>
      <paragraph num="(1)">
        <text>Standards for Grade “A” milk and milk products;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>The enforcement process for the examination, labeling, pasteurization, aseptic processing, retort processing, packaging, and distribution and sale of Grade “A” milk and milk products;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Penalties pursuant Health-General Article, §§21-211, 21-252— 21-256, 21-418, 21-419, 21-428, 21-1202, and 21-1203, Annotated Code of Maryland; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Requirements for Grade “A” dairy farms and milk facilities that produce, process, transport, store, or distribute Grade “A” milk or milk products.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="Definitions.">
    <paragraph num="A.">
      <text>In this chapter, the following terms have the meanings indicated.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Terms Defined.</text>
      <paragraph num="(1)">
        <text>“Bobtailer” means a person who operates or controls a Grade “A” milk route, and distributes Grade “A” pasteurized milk products that the person buys from a Grade “A” distributor or milk processor.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>“Bulk milk hauler/sampler” means a person who:</text>
        <paragraph num="(a)">
          <text>Collects official samples;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Transports raw milk from a farm or raw milk products to or from a milk plant, receiving station, or transfer station;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Possesses a permit from any state to sample raw milk or raw milk products; and</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Possesses a Maryland Bulk Milk Hauler license if they are sampling milk or raw milk products in Maryland.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>“Certified industry dairy farm inspector” means an individual who is certified by the Secretary under Health-General Article, §21-414, Annotated Code of Maryland, to carry out the inspections of dairy farms.</text>
      </paragraph>
      <paragraph num="(4)">
        <text>“Dairy farm” means a place where at least one cow, goat, or other hoofed mammal is kept, and from which the milk is sold or offered for sale.</text>
      </paragraph>
      <paragraph num="(5)">
        <text>“Department” means the Maryland Department of Health or the Department's designee.</text>
      </paragraph>
      <paragraph num="(6)">
        <text>“Extensive alteration” means the adding or tearing down of walls, plumbing, or other structural components of a dairy farm or milk plant.</text>
      </paragraph>
      <paragraph num="(7)">
        <text>“Grade “A” distribution station” means a place or vehicle where, for redistribution and sale, Grade “A” pasteurized milk products routinely are received, stored, or transferred.</text>
      </paragraph>
      <paragraph num="(8)">
        <text>“Grade “A” fluid milk” means pasteurized homogenized or pasteurized non-homogenized Grade “A” milk, cream, or half and half that has been processed to produce whole milk, low fat milk, or nonfat milk.</text>
      </paragraph>
      <paragraph num="(9)">
        <text>“Grade “A” milk or milk products” means the milk of a cow, goat, or other hoofed mammal that is produced, processed, pasteurized, bottled, packaged, or prepared in accordance with the Grade “A” Pasteurized Milk Ordinance.</text>
      </paragraph>
      <paragraph num="(10)">
        <text>“Impound” means to detain and hold milk or milk products under the authority of the Secretary, as provided under Health-General Article, §21-428, Annotated Code of Maryland.</text>
      </paragraph>
      <paragraph num="(11)">
        <text>“Improper handling” means Grade “A” milk or a milk product intended for human consumption that:</text>
        <paragraph num="(a)">
          <text>Has been adulterated;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Has been misbranded;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Has not been kept at the required temperature;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Is injurious to health if consumed; or</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Is otherwise unsafe.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(12)">
        <text>“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.</text>
      </paragraph>
      <paragraph num="(13)">
        <text>“Milk” means the milk of a cow, goat, or other hoofed mammal that is produced, processed, pasteurized, bottled, packaged, or prepared in accordance with the Grade “A” Pasteurized Milk Ordinance.</text>
      </paragraph>
      <paragraph num="(14)">
        <text>“Milk facility” means a:</text>
        <paragraph num="(a)">
          <text>Milk plant;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Grade “A” distribution station;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Receiving station;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Transfer station;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Milk processor; or</text>
        </paragraph>
        <paragraph num="(f)">
          <text>Milk tank truck cleaning facility.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(15)">
        <text>“Milk marketing agency” means a person who negotiates the price of milk to be offered for sale and supplies milk.</text>
      </paragraph>
      <paragraph num="(16)">
        <text>Milk Plant.</text>
        <paragraph num="(a)">
          <text>“Milk plant” means a place where, for distribution, milk products are:</text>
          <paragraph num="(i)">
            <text>Processed;</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>Pasteurized;</text>
          </paragraph>
          <paragraph num="(iii)">
            <text>Bottled or packaged; or</text>
          </paragraph>
          <paragraph num="(iv)">
            <text>Prepared.</text>
          </paragraph>
        </paragraph>
        <paragraph num="(b)">
          <text>“Milk plant” does not include a place where milk products are sold at retail only.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(17)">
        <text>“Milk processor” means a person who owns, operates, or controls a milk plant.</text>
      </paragraph>
      <paragraph num="(18)">
        <text>“Milk producer” means a person who:</text>
        <paragraph num="(a)">
          <text>Operates a dairy farm; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Provides, sells, or offers milk for sale to a:</text>
          <paragraph num="(i)">
            <text>Milk plant;</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>Receiving station; or</text>
          </paragraph>
          <paragraph num="(iii)">
            <text>Transfer station.</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="(19)">
        <text>“Milk tank truck” means a truck and its equipment that are used to transport milk or milk products.</text>
      </paragraph>
      <paragraph num="(20)">
        <text>“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.</text>
      </paragraph>
      <paragraph num="(21)">
        <text>“Milk transportation company” means a person who is responsible for a milk tank truck.</text>
      </paragraph>
      <paragraph num="(22)">
        <text>“Official laboratory” means a biological, chemical, or physical laboratory that is operated by the Department.</text>
      </paragraph>
      <paragraph num="(23)">
        <text>“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:</text>
        <paragraph num="(a)">
          <text>Producer samples of Grade “A” raw milk for pasteurization; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Commingled milk tank truck samples of Grade “A” raw milk.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(23-1)">
        <text>“On-farm processor” means a licensed milk plant that is located on the same premises as a licensed milk producer.</text>
      </paragraph>
      <paragraph num="(23-2)">
        <text>Pasteurization.</text>
        <paragraph num="(a)">
          <text>“Pasteurization” has the meaning stated in 21 CFR §131.3.</text>
        </paragraph>
        <paragraph num="(b)">
          <text>“Pasteurization” includes any other process found equivalent to pasteurization for milk and milk products as stated in 21 U.S.C. §343(h)</text>
        </paragraph>
      </paragraph>
      <paragraph num="(24)">
        <text>“Permit” means an official document 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.</text>
      </paragraph>
      <paragraph num="(25)">
        <text>“Permittee” means a person who holds a permit.</text>
      </paragraph>
      <paragraph num="(26)">
        <text>Person.</text>
        <paragraph num="(a)">
          <text>“Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.</text>
        </paragraph>
        <paragraph num="(b)">
          <text>“Person” includes:</text>
          <paragraph num="(i)">
            <text>An operator of a facility that is owned by a State or local unit of government; or</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>A State or local unit of government if the State or local unit of government is the operator of the facility.</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="(27)">
        <text>“Raw milk” means unpasteurized milk.</text>
      </paragraph>
      <paragraph num="(28)">
        <text>“Receiving station” means a place where, for delivery to a milk plant, raw milk is collected, cooled, and stored.</text>
      </paragraph>
      <paragraph num="(29)">
        <text>“Sale” or “sell” means a transaction that involves the:</text>
        <paragraph num="(a)">
          <text>Transfer, dispensing, or serving of milk and milk products with or without charge; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Right to acquire milk and milk products:</text>
          <paragraph num="(i)">
            <text>Through barter or contractual arrangement; or</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>In exchange for any other form of compensation including, but not limited to, an agistment agreement, which is the sale of shares or interest in a cow, goat, or other lactating hoofed mammal, or herd of cows, goats, or other lactating hoofed mammals.</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="(30)">
        <text>“Sanitization” means the application of an effective method or substance to clean surfaces to destroy pathogens and other microorganisms.</text>
      </paragraph>
      <paragraph num="(31)">
        <text>“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.</text>
      </paragraph>
      <paragraph num="(32)">
        <text>“Secretary” means the Secretary of Health or the Secretary's designee.</text>
      </paragraph>
      <paragraph num="(33)">
        <text>“Sell-by date” means the end of the sell-by period.</text>
      </paragraph>
      <paragraph num="(34)">
        <text>“Transfer station” means a place where milk is transferred directly from a milk tank truck to another milk tank truck for delivery to a milk plant.</text>
      </paragraph>
      <paragraph num="(35)">
        <text>“Ultra-pasteurization” means the process of heating milk or milk product in properly designed and operated equipment to a minimum of 280°F for at minimum two seconds, either before or after packaging, so as to produce a milk or milk product which has an extended shelf-life under refrigerated conditions.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Incorporation by Reference.">
    <text>In this chapter the following documents are incorporated by reference:</text>
    <paragraph num="A.">
      <text>Grade “A” Pasteurized Milk Ordinance, 20239evision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration);</text>
    </paragraph>
    <paragraph num="B.">
      <text>Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f, as amended;</text>
    </paragraph>
    <paragraph num="C.">
      <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535), as amended;</text>
    </paragraph>
    <paragraph num="D.">
      <text>FDA Food Safety Modernization Act, 21 U.S.C §§2201—2252, as amended; and;</text>
    </paragraph>
    <paragraph num="E.">
      <text>21 CFR §§130—131, as amended.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="General Requirements.">
    <paragraph num="A.">
      <text>The Department shall ensure that all inspections, sampling, testing, and enforcement actions performed by the State are carried out as set forth at and in compliance with the standards, requirements, and procedures specified at:</text>
      <paragraph num="(1)">
        <text>Health-General Article, Title 21, Annotated Code of Maryland;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535);</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Grade “A” Pasteurized Milk Ordinance; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>FDA Food Safety Modernization Act, 21 U.S.C §§2201—2252.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>A person engaged in an occupation involving Grade “A” milk shall conduct all Grade “A” milk activities as set forth at and in compliance with the standards, requirements, and procedures specified at:</text>
      <paragraph num="(1)">
        <text>Health-General Article, Title 21, Annotated Code of Maryland;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535); and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Grade “A” Pasteurized Milk Ordinance.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Standards for Milk Products.">
    <paragraph num="A.">
      <text>A permittee shall ensure that all raw milk for pasteurization and all pasteurized milk and milk products conform to the standards, requirements, and procedures established by the:</text>
      <paragraph num="(1)">
        <text>Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535);</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Health-General Article, §§21-422 and 21-434, Annotated Code of Maryland; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Grade “A” Pasteurized Milk Ordinance.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>A bulk milk hauler/sampler shall ensure that:</text>
      <paragraph num="(1)">
        <text>Bulk raw milk is delivered or received by the processor or receiving station within 12  hours of  pickup route completion;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Bulk raw milk is picked up from every dairy farm at least once every 72 hours; and;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>The temperature of the bulk raw milk does not exceed 45F.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>The person in charge of an official laboratory or officially designated laboratory shall ensure that:</text>
      <paragraph num="(1)">
        <text>The laboratory is operated according to the requirements established by the Grade “A” Pasteurized Milk Ordinance; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>All raw milk for pasteurization, all pasteurized milk and milk products, and all dairy product containers and lids are tested according to the requirements established by the Grade “A” Pasteurized Milk Ordinance.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".06" heading="Permits Required.">
    <paragraph num="A.">
      <text>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, to the Department before that person may:</text>
      <paragraph num="(1)">
        <text>Be a:</text>
        <paragraph num="(a)">
          <text>Bobtailer;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Bulk milk hauler/sampler;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Certified industry dairy farm inspector;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Milk processor;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Milk producer; or</text>
        </paragraph>
        <paragraph num="(f)">
          <text>Seasonal milk producer; or</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Operate a:</text>
        <paragraph num="(a)">
          <text>Grade “A” distribution station;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Milk tank truck cleaning facility;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Milk transportation company;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Receiving station; or</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Transfer station.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>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.</text>
    </paragraph>
    <paragraph num="C.">
      <text>Under Health-General Article, §21-410(c), Annotated Code of Maryland, a permit is not required for:</text>
      <paragraph num="(1)">
        <text>A milk producer who is outside the departmental inspection area if the raw milk from that milk producer is processed by a milk processor who holds a permit issued under this chapter;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>A bulk milk hauler/sampler who receives raw milk from outside the departmental inspection area;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>A grocery store, restaurant, soda fountain, or similar establishment where milk products are served or sold at retail if:</text>
        <paragraph num="(i)">
          <text>The establishment complies with all applicable provisions of Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, and all applicable rules or regulations; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The milk product is received from a permittee; or</text>
        </paragraph>
      </paragraph>
      <paragraph num="(4)">
        <text>An individual who only transports milk in a sealed tanker to a milk plant, receiving station, or transfer station and not producers’ samples.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".07" heading="Inspection and Evaluation of Milk Production and Transportation.">
    <paragraph num="A.">
      <text>Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall inspect:</text>
      <paragraph num="(1)">
        <text>A milk tank truck;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>A milk producer;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>A seasonal milk producer;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>A transfer station;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>A milk tank truck cleaning facility;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>A milk plant; and</text>
      </paragraph>
      <paragraph num="(7)">
        <text>A receiving station.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>The Secretary shall inspect a seasonal milk producer before the first shipment of milk and at least every 6 months until production of milk for sale has ceased.</text>
    </paragraph>
    <paragraph num="C.">
      <text>The Secretary shall inspect a Grade “A” distribution station at least once every 6 months.</text>
    </paragraph>
    <paragraph num="D.">
      <text>The Secretary shall inspect a bobtailer at least once every 12 months.</text>
    </paragraph>
    <paragraph num="E.">
      <text>Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall evaluate:</text>
      <paragraph num="(1)">
        <text>The ability of the certified industry dairy farm inspector to perform dairy farm inspections and raw milk sampling;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>The pick-up and sampling procedures that a bulk milk hauler/sampler performs; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>The sampling procedures of the industry plant sampler.</text>
      </paragraph>
    </paragraph>
    <paragraph num="F.">
      <text>The Secretary shall inspect and evaluate a bulk milk hauler/sampler as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 5 and Appendix B.</text>
    </paragraph>
    <paragraph num="G.">
      <text>The Secretary shall inspect a milk tank truck as set forth in the Grade “A” Pasteurized Milk Ordinance and Appendix B.</text>
    </paragraph>
    <paragraph num="H.">
      <text>Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix N, the Secretary shall evaluate:</text>
      <paragraph num="(1)">
        <text>Laboratories performing Grade “A” milk product testing for official use;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Laboratories performing drug residue testing; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Laboratory analysts performing testing as required by the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix N.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".08" heading="Improper Handling of Milk Products.">
    <paragraph num="A.">
      <text>Under Health-General Article, §21-428, Annotated Code of Maryland, and to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall impound Grade A milk or milk products intended for human consumption due to improper handling.</text>
    </paragraph>
    <paragraph num="B.">
      <text>After impounding the Grade A milk or milk product, the Secretary may issue an order to:</text>
      <paragraph num="(1)">
        <text>Dispose of the milk or milk product;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Make the milk or milk product unusable for consumption; or</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Under Health-General Article, §21-428, Annotated Code of Maryland, impose a civil monetary penalty, as set forth in §C of this regulation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>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.</text>
    </paragraph>
    <paragraph num="D.">
      <text>A person subject to an impoundment order may seek legal recourse as set forth at Health-General Article, §21-428, Annotated Code of Maryland, by:</text>
      <paragraph num="(1)">
        <text>Appealing a civil penalty; or</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Bringing an action for damages.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".09" heading="Labeling of Milk.">
    <text>A permittee shall ensure that milk product labels conform to the standards and requirements established by the:</text>
    <paragraph num="A.">
      <text>Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §§341—350f;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Nutrition Labeling and Education Act of 1990 (Public Law 101-535);</text>
    </paragraph>
    <paragraph num="C.">
      <text>Grade “A” Pasteurized Milk Ordinance; and</text>
    </paragraph>
    <paragraph num="D.">
      <text>Health-General Article, §§21-422, 21-424, and 21-425, Annotated Code of Maryland.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".10" heading="Dating of Grade “A” Fluid Milk.">
    <paragraph num="A.">
      <text>Unless approved by the Department as described in §B of this regulation, a person may not sell, deliver, or offer Grade “A” milk or milk products that are cooled to, packaged, and stored at 45°F or less for sale after 18 days from the date of processing.</text>
    </paragraph>
    <paragraph num="B.">
      <text>In order to sell, deliver, or offer Grade “A” milk or milk products that are cooled to, packaged, and stored at 45°F or less for sale after 18 days from the date of processing, an applicant shall:</text>
      <paragraph num="(1)">
        <text>Submit to the Department:</text>
        <paragraph num="(a)">
          <text>A written request; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>A shelf life study to show that the product meets standards set forth in this chapter; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Be approved by the Department.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>A permittee shall conspicuously and legibly mark the cap or non-glass container of Grade “A” fluid milk with the words “Sell by”, followed by the designation of the month and the day of the month after which the product may not be sold, delivered, or offered for sale.</text>
    </paragraph>
    <paragraph num="D.">
      <text>Milk products exempt from dating requirements are:</text>
      <paragraph num="(1)">
        <text>Cultured milk products and eggnog;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Milk and dairy products as defined by 21 CFR §§130—131, which have been subjected to aseptic processing and packaging; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Milk and dairy products as defined in 21 CFR §131.3(c), which have been subjected to ultra-pasteurization.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".11" heading="Sale and Handling of Milk by Food Service Facilities.">
    <paragraph num="A.">
      <text>Except as provided in §B of this regulation, a person may not offer Grade “A” fluid milk for sale beyond the sell-by date.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The following establishments may use or serve Grade “A” fluid milk up to 4 days beyond the sell-by date:</text>
      <paragraph num="(1)">
        <text>Food service facilities;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Hospitals;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Schools;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Institutions; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Places where milk is consumed on the premises.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>An establishment listed in §B of this regulation shall ensure that Grade “A” fluid milk is used by the establishment not later than 4 days beyond the sell-by date.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".12" heading="Sale of Raw Milk.">
    <paragraph num="A.">
      <text>Under Health-General Article, §21-434, Annotated Code of Maryland, a person may not sell raw milk for human consumption.</text>
    </paragraph>
    <paragraph num="B.">
      <text>A permitted milk producer may sell raw milk from the milk producer’s dairy farm only to a permitted:</text>
      <paragraph num="(1)">
        <text>Receiving station;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Transfer station;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Milk plant; or</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Milk marketing agency.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".13" heading="Dairy Farm Construction and Plan Submission.">
    <text>Pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, for construction, reconstruction, or extensive alteration of a dairy farm, a person shall submit to the Department:</text>
    <paragraph num="A.">
      <text>A plan and specifications before:</text>
      <paragraph num="(1)">
        <text>Constructing or reconstructing a milk house, milking barn, milking stable, or milking parlor;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Converting or remodeling an existing building or structure for use as a milk house, milking barn, milking stable, or milking parlor; or</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Adding, modifying, or replacing:</text>
        <paragraph num="(a)">
          <text>A bulk milk tank;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>A milking system;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Any part of a milking system;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>A washing system;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Any part of a washing system; or</text>
        </paragraph>
        <paragraph num="(f)">
          <text>A cooling system, including a plate cooler or bulk tank cooling system; and</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>A plan and drawing bearing the name of a professional engineer or a representative of the company performing the work;</text>
    </paragraph>
    <paragraph num="C.">
      <text>Contact information for the dairy farm, including:</text>
      <paragraph num="(1)">
        <text>The full name, title, and telephone number of each applicant;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>The name of the dairy farm;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>The mailing address;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>The location; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Directions to the site;</text>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>A site drawing showing the location of the milk house, milking barn, milking stable, milking parlor, and each animal housing area, with approximate distances in feet, to:</text>
      <paragraph num="(1)">
        <text>Manure pits;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Cow yards;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Silos;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Wells or other approved water systems;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Septic systems;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Frost free style watering hydrants;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Ditches; and</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Streams;</text>
      </paragraph>
    </paragraph>
    <paragraph num="E.">
      <text>A detailed drawing of the interior of the milk house, milking barn, milking stable, milking parlor, and each animal housing area indicating dimensions and showing the location of:</text>
      <paragraph num="(1)">
        <text>Equipment;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Pre-coolers;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Floor drains;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Lighting;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Hose bibs;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Watering troughs;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Frost free style watering hydrants;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Washing systems;</text>
      </paragraph>
      <paragraph num="(9)">
        <text>Chemical dispensers;</text>
      </paragraph>
      <paragraph num="(10)">
        <text>Compressors;</text>
      </paragraph>
      <paragraph num="(11)">
        <text>Back flow prevention devices; and</text>
      </paragraph>
      <paragraph num="(12)">
        <text>Toilets;</text>
      </paragraph>
    </paragraph>
    <paragraph num="F.">
      <text>For pipeline and milking system installations:</text>
      <paragraph num="(1)">
        <text>The make, model number, quantity, and specifications of milking equipment including pipeline and milking units;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>The make and model number of pumps used in the milking system, including specifications such as horsepower and cubic feet per minute;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>A drawing of the parlor or barn showing the location of:</text>
        <paragraph num="(a)">
          <text>Milking equipment;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Pipeline, including size and length of the piping;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Wash line, including size and length of the wash line;</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Receiver, if applicable;</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Pre-cooler, if applicable;</text>
        </paragraph>
        <paragraph num="(f)">
          <text>Any other milk equipment; and</text>
        </paragraph>
        <paragraph num="(g)">
          <text>The milk house, bulk tank, and animal housing area in relation to the milking parlor or milking barn;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(4)">
        <text>A description and diagram of the location of the back flow protection methods or devices that will be installed to protect the potable water supply on all plate coolers, chemical pumps, water lines, and other fixtures;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>The type, such as gas or electric, and capacity of the hot water heating system; and</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Information and specifications for booster or supplemental heating systems, if utilized;</text>
      </paragraph>
    </paragraph>
    <paragraph num="G.">
      <text>For bulk tank/milk cooling systems installation:</text>
      <paragraph num="(1)">
        <text>A drawing of the milk house with bulk tank location, floor drain locations, and clearance dimensions on both sides, in front, and above the manhole of the bulk tank;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Specific floor, wall, and ceiling finishes, if part of a new installation;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Bulk tank specifications, including make, model number, and capacity;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Cooling system specifications, including make, model number, and capacity; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Pre-cooler type and British thermal units capability, if applicable.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".14" heading="Dairy Farm Requirements.">
    <text>A milk producer shall ensure that:</text>
    <paragraph num="A.">
      <text>Construction of all equipment, milking barns, stables, parlors, milk houses, and each animal housing area complies with the requirements of the Grade “A” Pasteurized Milk Ordinance and Regulation .13 of this chapter, as applicable;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Water used at a dairy farm shall:</text>
      <paragraph num="(1)">
        <text>Be obtained from a water supply system that complies with:</text>
        <paragraph num="(a)">
          <text>Environment Article, Title 9, Annotated Code of Maryland;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>COMAR 26.04.04; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>The Grade “A” Pasteurized Milk Ordinance;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Be installed in a manner that prevents backflow or back-siphoning;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Be separate from a non-potable water supply system so that non-potable water cannot be drawn or discharged into the potable water supply system;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Provide hot and cold running water in areas where milk processing equipment is washed; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system;</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>Hand sinks shall have:</text>
      <paragraph num="(1)">
        <text>Either:</text>
        <paragraph num="(a)">
          <text>Hot and cold running water under pressure; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Warm running water;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>A supply of hand-cleaning soap or detergent; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>A sanitary means of drying hands, such as individual towels or a hand-drying device;</text>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>A sewage system is constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;</text>
    </paragraph>
    <paragraph num="E.">
      <text>Toilet facilities, if any, are constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;</text>
    </paragraph>
    <paragraph num="F.">
      <text>Plumbing is sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations; and</text>
    </paragraph>
    <paragraph num="G.">
      <text>Electrical systems comply with State and local electrical laws, ordinances, and regulations, and the Grade “A” Pasteurized Milk Ordinance.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".15" heading="Milk Facility Construction and Plan Submission.">
    <text>Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, for construction, reconstruction, or extensive alteration of a milk facility, a person shall submit to the Department:</text>
    <paragraph num="A.">
      <text>Plans and specifications before:</text>
      <paragraph num="(1)">
        <text>Constructing, reconstructing, or extensively altering a milk facility;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Converting or remodeling an existing building or structure for use as a milk facility;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Adding, replacing, relocating, or modifying a milk facility process; or</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Adding, modifying, or replacing a clean-in-place (CIP) or other washing system or any part of a clean-in-place or other washing system;</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>Plans and drawings bearing the name of a professional engineer or a representative of the company performing the work.</text>
    </paragraph>
    <paragraph num="C.">
      <text>Contact information for the facility, including:</text>
      <paragraph num="(1)">
        <text>The full name, title, and telephone number of each applicant;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>The name of the plant;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>The mailing address;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>The location; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Directions to the site;</text>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>A narrative describing the scope and purpose of the project, including a projected time line from start to completion;</text>
    </paragraph>
    <paragraph num="E.">
      <text>An estimate of finished product output per day;</text>
    </paragraph>
    <paragraph num="F.">
      <text>Sample product labels for each product;</text>
    </paragraph>
    <paragraph num="G.">
      <text>A list of:</text>
      <paragraph num="(1)">
        <text>All products to be produced;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Raw cream and skim, condensed, or any other milk or milk products to be sold; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Single service container sources;</text>
      </paragraph>
    </paragraph>
    <paragraph num="H.">
      <text>A scale drawing showing the layout and arrangement of areas within and around the milk facility, including areas for:</text>
      <paragraph num="(1)">
        <text>Processing;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Chemical storage;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Dry storage;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Ingredient and product storage;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Receiving;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Load out;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Laboratories;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Offices;</text>
      </paragraph>
      <paragraph num="(9)">
        <text>Restroom facilities;</text>
      </paragraph>
      <paragraph num="(10)">
        <text>Lockers or a facility for the storage of personal items; and</text>
      </paragraph>
      <paragraph num="(11)">
        <text>Employees to eat and drink beverages;</text>
      </paragraph>
    </paragraph>
    <paragraph num="I.">
      <text>A scale drawing showing the location of all equipment, including:</text>
      <paragraph num="(1)">
        <text>Pasteurizers and sterile systems;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Milk processing equipment;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Fillers;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Raw and pasteurized tanks and silos;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Clean-in-place (CIP) systems;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Glycol water tanks;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Recirculating cooling water tanks;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Boilers;</text>
      </paragraph>
      <paragraph num="(9)">
        <text>Boiler makeup tanks;</text>
      </paragraph>
      <paragraph num="(10)">
        <text>Culinary steam systems; and</text>
      </paragraph>
      <paragraph num="(11)">
        <text>Blow mold systems;</text>
      </paragraph>
    </paragraph>
    <paragraph num="J.">
      <text>A scale drawing showing the location of plumbing and plumbing fixtures, including:</text>
      <paragraph num="(1)">
        <text>Water lines;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Sewer lines;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Hand sinks;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Toilets;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Utility sinks;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Utensil washing sinks;</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Floor drains;</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Floor sinks;</text>
      </paragraph>
      <paragraph num="(9)">
        <text>Hose stations; and</text>
      </paragraph>
      <paragraph num="(10)">
        <text>All back flow prevention devices;</text>
      </paragraph>
    </paragraph>
    <paragraph num="K.">
      <text>A legend for each drawing;</text>
    </paragraph>
    <paragraph num="L.">
      <text>Specifications for:</text>
      <paragraph num="(1)">
        <text>Ventilation including, but not limited to, the type and location of:</text>
        <paragraph num="(a)">
          <text>An air filter;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>An air pump; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>A compressor;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Construction materials for the building and interior finishes; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Pasteurizer plate coolers, if separate from the pasteurization system;</text>
      </paragraph>
    </paragraph>
    <paragraph num="M.">
      <text>A list and description of all boiler, glycol, and recirculating water additives and water treatment;</text>
    </paragraph>
    <paragraph num="N.">
      <text>A description of the:</text>
      <paragraph num="(1)">
        <text>Type of disposal for wastewater and sewage;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Source and system for the facility’s potable water supply;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Lighting fixtures and placement; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Recirculating cooling system;</text>
      </paragraph>
    </paragraph>
    <paragraph num="O.">
      <text>Specification sheets, including manufacturer and model number of all milk facility equipment;</text>
    </paragraph>
    <paragraph num="P.">
      <text>A document that lists the flow for all products through the plant, grouped in categories, identifying each functional piece of equipment and each process used in processing and packaging, including:</text>
      <paragraph num="(1)">
        <text>Reclamation systems;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Standardization procedures or formulation procedures, or both;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Vitamin addition protocol; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Draining of product lines;</text>
      </paragraph>
    </paragraph>
    <paragraph num="Q.">
      <text>Plans, specifications, drawings, and flow diagrams for each high temperature short time (HTST) and higher heat short time (HHST) system, showing each functional component;</text>
    </paragraph>
    <paragraph num="R.">
      <text>Clean-in-place (CIP) flow diagrams from the makeup tanks through all equipment;</text>
    </paragraph>
    <paragraph num="S.">
      <text>Information and drawings on how separation from product lines will be accomplished, if applicable;</text>
    </paragraph>
    <paragraph num="T.">
      <text>Written step-by-step standard operating procedures for:</text>
      <paragraph num="(1)">
        <text>Receiving, processing, storing, and packaging of each project;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Drug residue testing;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Cleaning and sanitization for all equipment;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Cleaning and sanitization for the facility;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Product trace back, inclusive of production or make sheet; and</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Product recall;</text>
      </paragraph>
    </paragraph>
    <paragraph num="U.">
      <text>A pest control program; and</text>
    </paragraph>
    <paragraph num="V.">
      <text>Employee training and personal hygiene practices.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".16" heading="Milk Physical Plant Requirements.">
    <paragraph num="A.">
      <text>Water used at a milk facility shall:</text>
      <paragraph num="(1)">
        <text>Be obtained from a potable water supply system that complies with:</text>
        <paragraph num="(a)">
          <text>Environment Article, Title 9, Annotated Code of Maryland;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>COMAR 26.04.04; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>The Grade “A” Pasteurized Milk Ordinance;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Be installed in a manner that prevents backflow or back-siphoning; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Be separate from a non-potable water supply system so that non-potable water cannot be drawn or discharged into the potable water supply system;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Provide hot and cold running water in areas where milk processing equipment is washed; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>Hand sinks shall have:</text>
      <paragraph num="(1)">
        <text>Either:</text>
        <paragraph num="(a)">
          <text>Hot and cold running water under pressure; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Warm running water;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>A supply of hand-cleaning soap or detergent; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>A sanitary means of drying hands, such as individual towels or a hand-drying device.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>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.</text>
    </paragraph>
    <paragraph num="D.">
      <text>Plumbing shall be sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations.</text>
    </paragraph>
    <paragraph num="E.">
      <text>Toilet facilities shall:</text>
      <paragraph num="(1)">
        <text>Be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>For a milk plant that is not an on-farm processor, be available within the physical plant for use by employees; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>For a milk plant that is an on-farm processor, if not located within the physical plant building:</text>
        <paragraph num="(a)">
          <text>Be located within 500 feet of the physical plant building;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Be accessible at all times that the plant is in operation;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Have documented and implemented measures for re-entry into the plant to protect against facility and product contamination; and</text>
        </paragraph>
        <paragraph num="(d)">
          <text>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 COMAR 26.04.02.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="F.">
      <text>Electrical systems at the facility shall:</text>
      <paragraph num="(1)">
        <text>Comply with State and local electrical laws, ordinances, and regulations;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Provide adequate lighting sources that furnish at least 40 foot-candles of light in all working areas in all rooms where:</text>
        <paragraph num="(a)">
          <text>Milk or milk products are handled, processed, packaged, or stored; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Containers, utensils, and equipment are washed; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>Provide adequate lighting sources that furnish at least 20 foot-candles of light in dry storage and cold storage rooms.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".17" heading="Plan Review Approval.">
    <paragraph num="A.">
      <text>An applicant may not construct, reconstruct, or extensively alter a plant without prior plan approval from the Department.</text>
    </paragraph>
    <paragraph num="B.">
      <text>An applicant for a permit shall submit a plan to the Department that includes the requirements set forth in Regulations .13—.16 of this chapter.</text>
    </paragraph>
    <paragraph num="C.">
      <text>The Department shall:</text>
      <paragraph num="(1)">
        <text>Review the plan submitted under this regulation to ensure compliance with the requirements set forth in Regulations .13—.16 of this chapter; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Inform the applicant:</text>
        <paragraph num="(a)">
          <text>That the plan has been received;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>If additional information is required to complete the plant review;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Whether the plan is approved or denied; and</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Of the appeal process if the plan is denied.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".18" heading="Confidentiality.">
    <text>The Department shall maintain confidentiality of records submitted by a person in accordance with General Provisions Article, §4-335, Annotated Code of Maryland.</text>
  </regulation>
  <regulation prefix="Regulation" num=".19" heading="Suspension and Revocation of Permits.">
    <paragraph num="A.">
      <text>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.</text>
    </paragraph>
    <paragraph num="B.">
      <text>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.</text>
    </paragraph>
    <paragraph num="C.">
      <text>The Department may suspend a permit if the permittee fails or neglects to correct a violation within the specified time period.</text>
    </paragraph>
    <paragraph num="D.">
      <text>If a permit has been suspended more than once, the Secretary may revoke the permit.</text>
    </paragraph>
    <paragraph num="E.">
      <text>The Department shall ensure that an opportunity for a hearing is provided to a person whose permit has been suspended or revoked.</text>
    </paragraph>
    <paragraph num="F.">
      <text>When an immediate and substantial danger is found to exist to public health, safety, or welfare that imperatively requires emergency action, pursuant to Health-General Article, §21-418(c) and State Government Article, §10-226(c)(2), Annotated Code of Maryland, the:</text>
      <paragraph num="(1)">
        <text>Department shall:</text>
        <paragraph num="(a)">
          <text>Summarily suspend the permit;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Order the permittee to cease operation immediately; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Promptly provide the permittee with:</text>
          <paragraph num="(i)">
            <text>A written notice of the suspension of the permit;</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>The reasons for the suspension; and</text>
          </paragraph>
          <paragraph num="(iii)">
            <text>An opportunity to be heard; and</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Permittee shall immediately cease operation upon the receipt of the summary suspension order.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".20" heading="Appeals Process.">
    <text>In accordance with the Administrative Procedures Act and Health-General Article, §21-419, Annotated Code of Maryland, the Department shall ensure that an opportunity for a hearing is provided to a permittee whose plan review or permit has been:</text>
    <paragraph num="A.">
      <text>Denied;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Suspended; or</text>
    </paragraph>
    <paragraph num="C.">
      <text>Revoked.</text>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Health-General Article, §§2-104, 2-105, 21-207, 21-208, 21-210, 21-211, 21-406, and 21-428, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: July 1, 1972</annotation>
    <annotation type="History" subtype="Administrative History">Regulations .01 and .03A amended effective February 2, 1977 (4:3 Md. R. 145)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .01AA, FF adopted effective August 25, 1978 (5:17 Md. R. 1330)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted effective February 12, 2007 (34:3 Md. R. 299)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .01-2 adopted effective February 12, 2007 (34:3 Md. R. 299)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03A amended effective October 20, 1997 (24:21 Md. R. 1449)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03C amended effective August 25, 1978 (5:17 Md. R. 1330)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03D, E effective September 6, 1974</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03F adopted effective January 11, 1980 (7:1 Md. R. 44)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03F repealed effective October 20, 1997 (24:21 Md. R. 1449)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06 amended as an emergency provision effective April 6, 2006 (33:9 Md. R. 795); amended permanently effective August 28, 2006 (33:17 Md. R. 1436)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06C amended effective September 5, 1988 (15:18 Md. R. 2148); September 13, 1993 (20:18 Md. R. 1430)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .08B amended effective August 24, 1979 (6:17 Md. R. 1394)</annotation>
    <annotation type="History" subtype="Administrative History">Regulations .01—.11 repealed and new Regulations .01—.19 adopted effective March 19, 2010 (37:4 Md. R. 341)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03A amended effective March 7, 2011 (38:5 Md. R. 317)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03A amended effective October 15, 2012 (39:20 Md. R. 1306)</annotation>
    <annotation type="History" subtype="Administrative History">Chapter revised effective February 27, 2017 (44:4 Md. R. 254)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .02B amended effective May 18, 2020 (47:10 Md. R. 517); August 5, 2024 (51:15 Md. R. 708)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 5, 2024 (51:15 Md. R. 708)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03A amended effective May 18, 2020 (47:10 Md. R. 517)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03B amended effective February 16, 2026 (53:3 Md. R. 122)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05B amended effective August 5, 2024 (51:15 Md. R. 708)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .10D amended effective August 5, 2024 (51:15 Md. R. 708)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .11 amended effective August 5, 2024 (51:15 Md. R. 708)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .16E adopted effective May 18, 2020 (47:10 Md. R. 517)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .16F amended effective May 18, 2020 (47:10 Md. R. 517)</annotation>
  </annotations>
</chapter>