# Health - General (GHG)

## Title 21. Food, Drugs, and Cosmetics

### Subtitle 3. Food Establishments

#### Section 21-301

(a) In this subtitle the following words have the meanings indicated.

(b)

  (1) "Bottled water" means any water that is sealed in bottles, packages, or other containers and offered for sale for human consumption, including bottled mineral water.

  (2) "Bottled water" does not include:

    (i) Soft drinks; or

    (ii) A beverage that is labeled "club soda" or "seltzer water".

(b-1) "Cottage food business" means a business that:

  (1) Produces or packages cottage food products in a residential kitchen;

  (2) Sells the cottage food products in accordance with Sec. 21-330.1 of this subtitle and regulations adopted by the Department; and

  (3) Has annual revenues from the sale of cottage food products in an amount not exceeding $100,000.

(b-2) "Cottage food product" means a nonhazardous food, as specified in regulations adopted by the Department, that is sold in the State in accordance with Sec. 21-330.1 of this subtitle and regulations adopted by the Department:

  (1) Directly to a consumer from a residence, at a farmer's market, at a public event, by personal delivery, or by mail delivery; or

  (2) To a retail food store, including a grocery store, or a food cooperative.

(c) "Crab meat" means the edible meat of steamed or cooked crabs.

(d) "Crab meat plant" means:

  (1) A picking plant; or

  (2) A place where crab meat is heat-treated to improve the keeping quality of the crab meat.

(e) "Excluded organization" means:

  (1) A bona fide nonprofit fraternal, civic, war veterans', religious, or charitable organization or corporation that does not serve food to the public more often than 4 days per week except that once a year an organization may serve food to the public for up to 30 consecutive days; and

  (2) A volunteer fire company that does not serve food to the public more often than 4 days per week except that once a year a volunteer fire company may serve food to the public for up to 30 consecutive days.

(f) "Food establishment" means:

  (1) A food service facility; or

  (2) A food processing plant.

(g)

  (1) "Food processing plant" means any place used for, or in connection with, the commercial manufacturing, preparing, processing, packaging, canning, freezing, storing, distributing, labeling, or holding of food or drink for human consumption.

  (2) "Food processing plant" includes:

    (i) A bakery plant;

    (ii) A cannery;

    (iii) A confectionery plant;

    (iv) A crab meat picking plant;

    (v) A food manufacturing plant;

    (vi) A food warehouse or distribution center;

    (vii) A frozen food processing plant;

    (viii) An ice manufacturing plant;

    (ix) A shellfish plant;

    (x) A soft drink manufacturing plant; or

    (xi) A bottled water plant.

  (3) "Food processing plant" does not include:

    (i) A warehouse or distribution center that:

      (1) Does not process food; and

      (2) Stores only sealed containers of whole bean, ground or instant coffee, leaf or instant teas, nondairy dehydrated whiteners, sugar, or sugar-free sweeteners; or

    (ii) A cottage food business.

(h)

  (1) "Food service facility" means:

    (i) A place where food or drink is prepared for sale or service on the premises or elsewhere; or

    (ii) Any operation where food is served to or provided for the public, with or without charge.

  (2) "Food service facility" includes a micro market licensed under Title 17, Subtitle 17 of the Business Regulation Article.

  (3) "Food service facility" does not include:

    (i) A kitchen in a private home where food is prepared at no charge for guests in the home, for guests at a social gathering, or for service to unemployed, homeless, or other disadvantaged populations;

    (ii) A food preparation or serving area where food is prepared or served only by an excluded organization;

    (iii) A location in a farmer's market or at a public festival or event where raw agricultural products, as defined in Sec. 21-304(d)(1)(iii) of this subtitle, are sold; or

    (iv) A cottage food business.

(i) "License" means a license issued by the Department under this subtitle to operate a food establishment.

(i-1) "Mobile food service facility" means a food service facility which is a mechanically, electrically, manually, or otherwise propelled vehicle operating on land or water.

(j) "Picking plant" means a place where:

  (1) Crabs are steamed or cooked;

  (2) Crab meat is picked from crabs; and

  (3) Crab meat is packed for sale.

(j-1) "Public festival or event" means a planned gathering that is open to the public and is regulated by the State or local jurisdiction in which it takes place.

(j-2)

  (1) "Semipermanent food service facility" means a food service facility that:

    (i) Is built at a location other than where it operates;

    (ii) Is transported as a complete unit that does not require a building permit to install on the location at which it operates;

    (iii) Has no indoor seating for patrons; and

    (iv) When serving cooked food, serves only foods cooked for immediate service.

  (2) "Semipermanent food service facility" does not include a food service facility that is a mechanically, electrically, manually, or otherwise propelled vehicle operating on land or water that moves as part of its routine operation to:

    (i) Change location for sales;

    (ii) Obtain food and other supplies;

    (iii) Fill potable water supply holding tanks;

    (iv) Empty wastewater holding tanks; or

    (v) Provide for the cleaning and sanitation of equipment and utensils.

(k)

  (1) Except as provided under paragraph (2) of this subsection, "soft drink" means any nonalcoholic beverage.

  (2) "Soft drink" does not include:

    (i) Apple cider;

    (ii) Soft drinks that are manufactured on the premises of a soda fountain and used at that soda fountain; or

    (iii) Bottled water.

(l) "Surimi" means an intermediate manufactured seafood product derived from minced fish meat, washed to remove water-soluble protein and blood or other undesirable components and mixed with additives to enhance its frozen storage and functional characteristics.

#### Section 21-302

This subtitle does not apply to the manufacture of milk, milk products as defined in Sec. 21-401 of this title, or frozen desserts as defined in Sec. 21-801 of this title.

#### Section 21-303

The purpose of this subtitle is to provide that all food establishments in this State are constructed, operated, and maintained in a manner that assures that all food manufactured, processed, stored, or prepared for human consumption is done so under conditions necessary to protect the public health, safety, and welfare.

#### Section 21-304

(a)

  (1) The Department shall adopt rules and regulations necessary to carry out the provisions of this subtitle.

  (2) For excluded organizations, the Department:

    (i) Shall adopt separate regulations that establish minimum standards that:

      (1) Ensure food integrity and safety;

      (2) Preserve public health; and

      (3) Control foodborne illnesses;

    (ii) May adopt separate regulations that establish a licensing system, with appropriate standards, that excluded organizations may voluntarily choose to submit to as a rescindable alternative to regulation under item (i) of this paragraph; and

    (iii) May adopt regulations governing excluded organizations serving potentially hazardous food prepared in a private kitchen.

(b) Except as provided in subsection (e) of this section, a political subdivision may not adopt a law, ordinance, rule, or regulation that establishes a standard that is less stringent than rules and regulations adopted under this subtitle.

(c) Except as otherwise provided in this section, this subtitle does not limit the power of a home rule or charter county or Baltimore City to adopt and enforce laws, ordinances, and regulations that are consistent with the purposes of this subtitle, including the power to adopt local licensing and enforcement procedures.

(d)

  (1)

    (i) In this subsection the following words have the meanings indicated.

    (ii) "Farmer's market" means a public market in the State where producers of raw agricultural products sell the products directly to the public.

    (iii) "Raw agricultural product" includes:

      (1) Whole, unprocessed grains, flowers, herbs, nuts, fruits, and vegetables supplied directly from the farm on which they were produced; and

      (2) Any agricultural products the Department identifies in regulation.

  (2) A local jurisdiction may not require a license for the sale of raw agricultural products at a farmer's market or at a public festival or event.

(e)

  (1) The governing body of Frederick County may adopt an ordinance to allow a restaurant with an outdoor dining area to allow a patron's dog to accompany the patron in the outdoor dining area.

  (2) An ordinance adopted under paragraph (1) of this subsection shall:

    (i) Prohibit a dog from being allowed to travel through an indoor space of a restaurant to enter or exit an outdoor dining area; and

    (ii) Contain a provision to ensure that the ordinance does not affect the right of an individual to use a service animal, as defined in Sec. 7-701 of the Human Services Article.

(f)

  (1)

    (i) In this section the following words have the meanings indicated.

    (ii) "Base of operations" means a location used by the owner or operator of a mobile food service facility that provides:

      (1) A source of potable water, potable water hoses, and clean connections;

      (2) A method for the disposal of sewage;

      (3) Clean, adequate, and covered trash receptacles;

      (4) If necessary, refrigerated and dry food storage areas;

      (5) A storage area for single-serve food items; and

      (6) If necessary, a utensil washing facility.

    (iii) "County of origin" means the county in which the base of operations of a mobile food service facility is located.

    (iv) "Mobile food service facility" means a food service facility that:

      (1) Is a vehicle mechanically, electrically, manually, or otherwise propelled;

      (2) Operates on land or water; and

      (3) Changes its location as part of its routine sales operation.

    (v) "Mobile reciprocity license" means a license issued under paragraph (3) of this subsection.

  (2) This subsection does not apply to a mobile food service facility that operates solely under a temporary food service license in conjunction with fairs, carnivals, or similar events.

  (3) A county health department shall issue a mobile reciprocity license to a mobile food service facility that:

    (i) Is operating in the county;

    (ii) Is operating within 90 miles of its base of operations; and

    (iii) Holds a valid license from the county of origin.

  (4) A county health department may charge a fee for a mobile reciprocity license in an amount not exceeding $300.

  (5) A mobile reciprocity license is valid for a period of 1 year.

  (6) If a mobile food service facility has been inspected by the county of origin, a county may not require that the mobile food service facility be inspected before a county health department issues a mobile reciprocity license.

  (7) A county health department that issued a mobile reciprocity license may inspect the mobile food service facility while the mobile food service facility is operating in the county.

  (8) A mobile food service facility that is issued a mobile reciprocity license shall comply with all applicable State and local laws and regulations.

  (9)

    (i) A county health department may take enforcement action, including the levy of fines, against a mobile food service facility that violates this subtitle or any regulation adopted under this subtitle or any applicable local laws or regulations.

    (ii) If a county health department takes enforcement action under subparagraph (i) of this paragraph, the county health department shall notify the county of origin of the action taken.

#### Section 21-304.1

(a) A volunteer fire company that meets the requirements of an excluded organization under Sec. 21-301(e) of this subtitle shall provide written notice to the Department that the volunteer fire company intends to serve food to the public for up to 30 consecutive days.

(b) The written notice shall include the dates on which the food will be prepared, the methods of storing and serving the food, and the methods or procedures to be followed to ensure food safety and security.

#### Section 21-304.2

(a) A restaurant with an outdoor dining area may allow a patron's dog to accompany the patron in the outdoor dining area during the hours designated by the owner of the restaurant.

(b) The owner of a restaurant:

  (1) Shall provide written notice to the local health department that the owner intends to allow a patron's dog to accompany the patron in the outdoor dining area of the restaurant not less than 30 days prior to the day on which dogs will be allowed in the outdoor dining area;

  (2) May determine the location and the amount of space in the outdoor dining area designated for a patron accompanied by a dog;

  (3) May establish limits on the size and type of dogs and any other limitations relating to dogs that may accompany a patron into the outdoor dining area of a restaurant;

  (4) May deny entry to the restaurant or eject from the restaurant any patron accompanied by a dog at the discretion of the owner; and

  (5) Shall place on permanent display a written notice that is in a typeface that is large enough to be easily legible to the average person from a distance of 8 feet and that is in a location that is plainly visible to the patrons of the restaurant notifying the patrons of the policy of the restaurant allowing dogs in the outdoor dining area.

(c) A patron accompanied by a dog:

  (1) May not allow the dog to travel through an indoor space of a restaurant to enter or exit an outdoor dining area;

  (2) Shall keep the dog on a leash at all times with the patron at the table at which the patron is seated;

  (3) May not leave the dog unattended at any time in the restaurant;

  (4) Shall be an adult who is responsible for the behavior of the dog; and

  (5) Is liable for any damages caused by the dog to the restaurant or any other patron of the restaurant.

(d) This section does not affect the right of an individual to use a service animal, as defined in Sec. 7-701 of the Human Services Article.

#### Section 21-305

(a) Except as otherwise provided in this subtitle, a person may not operate a food establishment unless the person is licensed by the Department.

(b)

  (1) A separate license is required for each food establishment that a person owns or operates.

  (2) Except in Baltimore City, the provisions of this subsection may require a license for each location where vending machines are operated, but may not require a separate license for each individual vending machine.

  (3) Except in Baltimore City, vending machine locations used exclusively for prepackaged and commercially sealed foods that are not potentially hazardous, as defined by regulation, are not required to be licensed.

  (4) In Baltimore City, a license may be required for each individual vending machine.

  (5)

    (i) An excluded organization may operate a food establishment without a license unless the excluded organization has been issued a license under Sec. 21-304(a)(2)(ii) of this subtitle.

    (ii) If the Department adopts regulations governing excluded organizations serving potentially hazardous foods prepared in a private kitchen, an excluded organization shall meet any requirements in the regulations.

  (6) A license is not required for a person who:

    (i) Produces shell eggs;

    (ii) Sells the shell eggs directly to the public; and

    (iii) Is registered with or inspected by the Secretary of Agriculture under Sec. 4-310 or Sec. 4-311.1 of the Agriculture Article.

  (7) A license is not required for a person who:

    (i) Is licensed by the Department of Natural Resources under Sec. 4-701 or Sec. 4-701.1 of the Natural Resources Article; and

    (ii) Harvests and processes finfish on a vessel by ikejime for direct sale to restaurants.

  (8) Except as provided in Sec. 21-304 of this subtitle, nothing in this subtitle shall preempt the right of a county to require a permit under the authority provided by a local law, ordinance, or regulation if this subtitle does not require the food establishment to obtain a State license.

(c) A license is not transferable:

  (1) Except as provided by regulation for transfer of the license on the death of the licensee from person to person; or

  (2) From location to location, except for a producer mobile farmer's market license under Sec. 21-309.1 of this subtitle.

(d)

  (1) For the purposes of this section a license issued by a county health department under the authority provided by local law, ordinance, or regulation in accordance with Sec. 21-304(b) and (c) of this subtitle shall constitute the license required under this subtitle, unless the Department, after a hearing, determines that the licensee is not in compliance with this subtitle and regulations adopted under this subtitle.

  (2) After a determination of noncompliance under paragraph (1) of this subsection, the Department shall act to ensure that the food establishment and its operator comply with this subtitle and the rules and regulations adopted under this subtitle.

  (3) Nothing in this subtitle shall allow the issuance of 2 separate licenses issued solely for the regulation of a food establishment under this subtitle.

(e) In Charles County, an issuance, renewal, or transfer of an off-sale alcoholic beverages license shall not require Department approval.

(f) In Carroll County, a bona fide religious organization that meets the requirements of an excluded organization under Sec. 21-301 of this subtitle or a county-owned and county-operated park or facility that is hosting a public festival may offer for sale or sell the following types of homemade-style food if the food is produced at the organization, park, or facility and meets the appropriate health and safety standards adopted by the Department:

  (1) Fruit jellies, jams, and preserves made from apples, apricots, blackberries, blueberries, boysenberries, cherries, cranberries, grapes, nectarines, oranges, peaches, plums, quince, raspberries, red currants, strawberries, or tangerines;

  (2) Fruit butter made from apples, apricots, grapes, peaches, plums, prunes, or quince;

  (3) Fruit pies made from apples, apricots, blackberries, blueberries, boysenberries, cherries, cranberries, grapes, nectarines, oranges, peaches, plums, quince, raspberries, red currants, strawberries, or tangerines; and

  (4) Honey.

#### Section 21-306

(a) To apply for a license, an applicant shall submit an application to the Department on the form that the Department requires.

(b) The application form shall include:

  (1) The applicant's name and address;

  (2) The location of the food establishment for which application is made;

  (3) The type of food establishment that the applicant proposes to operate; and

  (4) Any other information the Department requires.

#### Section 21-307

(a) To qualify for a license, an applicant shall:

  (1) Comply with the requirements of this subtitle and the rules and regulations adopted under this subtitle;

  (2) Agree to permit access to the food establishment for the purpose of any inspection permitted or required under this subtitle; and

  (3) Pay the license fee assessed under Sec. 21-308 of this subtitle, unless exempted from the fee under this subtitle or any rule or regulation adopted under this subtitle.

(b) Before issuing a license, the Department may inspect the food establishment identified in the application to determine if the food establishment meets the requirements for a license.

#### Section 21-308

(a) In this section, "on-farm home processing facility" means a home or domestic kitchen located on an individual's farm that manufactures and processes foods for commercial sale.

(b)

  (1) For any license issued for which the authority to conduct a program under this subtitle has been delegated to a county health department:

    (i) A county governing body or the Mayor and City Council of Baltimore City may and the Anne Arundel County Council shall provide for a license fee schedule based on the anticipated cost of licensing, inspecting, and regulating food establishments and may provide for exemptions from the license fee schedule; and

    (ii) All license fees shall be paid to the local health department or chief financial officer of the county governing body or Baltimore City.

  (2) Except in Anne Arundel County, Baltimore City, Montgomery County, and Prince George's County, a license fee under this subsection may not exceed $70 for a seasonal food processing operation that:

    (i) Uses only food that is grown on the property of the licensee; and

    (ii) Is in operation for not more than a 3-month continuous period in the calendar year.

  (3) A seasonal food processing operation may obtain a food establishment license for a fee of $70 under paragraph (2) of this subsection only twice in a calendar year.

(c)

  (1) An on-farm home processing facility may obtain an on-farm home processing plant license for a fee established in regulations.

  (2) An on-farm home processing facility that obtains an on-farm home processing plant license may manufacture or process only foods provided for in regulations of the Department.

  (3) A license or permit is not required to deliver prepackaged foods to fill an order of a customer.

(d) For any other food establishment license, the Secretary shall establish a license fee in accordance with Sec. 2-104 of this article.

(e) Notwithstanding any other provision of this section, a license fee under this section may not exceed $150 annually for a food processing plant that:

  (1) Is a bona fide civic or nonprofit organization that processes meat for human consumption; and

  (2) Engages in the processing of meat for human consumption no more than three times a year for 5 days or less each time.

#### Section 21-309

(a)

  (1) In this section the following terms have the meanings indicated.

  (2) "On-farm food service facility" means a food service facility that:

    (i) Is located on a farm;

    (ii) Serves food as designated by the Department; and

    (iii) Operates during a period of time of not more than 30 consecutive days with up to two renewals in a 1-year period.

  (3) "Temporary food service facility" means a food service facility that operates during a period of time of not more than 30 consecutive days at a fixed location in conjunction with a fair, carnival, public exhibition, construction project, recreational facility, or similar gathering.

(b)

  (1) Except as provided in Sec. 10-226 of the State Government Article and in paragraphs (2) and (3) of this subsection, and unless it is renewed for another term, a license expires 1 year from the date of issuance or renewal or as provided by local law, ordinance, or regulation in accordance with Sec. 21-304(b) and (c) of this subtitle.

  (2) Except as provided in Sec. 10-226 of the State Government Article, a license to operate a temporary food service facility expires at the conclusion of the underlying event or after 30 consecutive days of operation, whichever is earlier, or as provided by local law, ordinance, or regulation in accordance with Sec. 21-304(b) and (c) of this subtitle.

  (3)

    (i) Except as provided in Sec. 10-226 of the State Government Article, a license to operate an on-farm food service facility expires after 30 consecutive days unless it is renewed in accordance with subparagraph (ii) of this paragraph.

    (ii) An on-farm food service facility may renew an on-farm food service facility license up to two times within a 1-year period.

(c) Except in the case of a temporary food service facility, including a mobile food service facility which operates solely as a temporary food service facility, or an on-farm food service facility, at least 1 month before the license expires, the Department shall send to the licensee, by first-class mail to the last known address of the licensee, a renewal notice that states:

  (1) The date on which the current license expires; and

  (2) The date by which the completed renewal application must be received by the Department for the renewal to be issued and mailed before the license expires.

(d) The Department may renew a license if the licensee:

  (1) Has complied with this subtitle and the regulations adopted under this subtitle;

  (2) Submits to the Department a completed renewal application on the form the Department requires;

  (3) Pays the renewal fee assessed under Sec. 2-104 of this article, unless exempted from the fee under this subtitle or any regulation adopted under this subtitle; and

  (4) Agrees to permit access to the food establishment for purposes of any inspection permitted or required under this subtitle.

#### Section 21-309.1

(a)

  (1) The Department shall establish a producer mobile farmer's market license.

  (2) The fee for a producer mobile farmer's market license:

    (i) Shall be based on the anticipated cost of licensing, inspecting, and regulating licensees; and

    (ii) May not exceed $100.

  (3) A producer mobile farmer's market license shall be valid for a period of 1 year.

(b) A producer mobile farmer's market licensee may transport to and sell at a farmer's market or at a public festival or event:

  (1) Products that were produced by the licensee under an on-farm home processing plant license;

  (2) Products produced by the licensee, as authorized by the Department in regulation; or

  (3) Farm products that have been inspected, licensed, or certified for food safety by the Maryland Department of Agriculture.

(c)

  (1) A producer mobile farmer's market license is valid in all jurisdictions in the State.

  (2) A county or municipality may not require a producer mobile farmer's market licensee to obtain a separate permit or license to sell products authorized for sale under the producer mobile farmer's market license.

(d) The Department shall:

  (1) Issue producer mobile farmer's market licenses;

  (2) At least once a year, inspect each mobile unit that operates under a producer mobile farmer's market license; and

  (3) Adopt regulations to implement this section.

(e) A producer mobile farmer's market license shall be displayed on any mobile unit operating under the license.

(f)

  (1) A person in violation of this section or a regulation adopted under this section is subject to a fine not to exceed $1,000.

  (2) A county health department shall enforce and levy fines for a violation of this section or any regulations adopted under this section.

  (3) Fines assessed by a county health department shall be paid to the county in which the violation occurred.

  (4) A county health department shall notify the Department of any violations occurring in the county.

#### Section 21-309.2

(a) A county may establish a seasonal farmer's market producer sampling license to be required for a producer of a farm product to prepare and offer samples of the farm product for human consumption at a farmer's market or at a public festival or event.

(b) A county seasonal farmer's market producer sampling license established under this section shall:

  (1) Be valid at all farmer's markets in the county;

  (2) Be valid at any public festival or event in the county;

  (3) Be valid for the entire season for which it is issued; and

  (4) Have a single fee as set by the county.

(c) A seasonal farmer's market producer sampling licensee shall use the license only to offer samples of a farm product that has been produced by the licensee.

(d) The Department shall adopt regulations that:

  (1) Establish eligibility for the license;

  (2) Provide for the authorized uses of the license;

  (3) Establish standards and approved methods under which sampling shall be conducted;

  (4) Specify the duration of the season during which the license is valid; and

  (5) Include other provisions that are necessary to protect public health and control foodborne illnesses.

(e) A county issuing a seasonal  farmer's market  producer sampling license shall adopt an ordinance that:

  (1) Sets the fee for the license;

  (2) Provides for the enforcement of provisions of law under which the license is issued; and

  (3) Provides penalties for violations of provisions of law under which the license is issued.

#### Section 21-309.3

#### Section 21-310

(a) Within 30 days after the Department receives an application for a license, the Department shall issue a license to any applicant who meets the requirements of this subtitle and all regulations adopted under this subtitle.

(b) While it is effective, a license authorizes the licensee to operate the food establishment identified on the license.

#### Section 21-311

(a) The Department may deny an application for a food establishment license issued under this subtitle if the Department finds that the applicant:

  (1) Does not meet the requirements of this subtitle or any rules or regulations adopted under this subtitle; or

  (2) Fraudulently or deceptively attempts to obtain a license.

(b) Within 30 days of receipt of the completed application, the Department shall notify the applicant in writing:

  (1) That the application has been denied;

  (2) The specific reasons for the denial of the application; and

  (3) If any, the actions that must be taken by the applicant to qualify for a license.

(c) After a notice of denial is issued, the Department may issue a license to an applicant if the applicant:

  (1) Takes all actions specified in the notice of denial; and

  (2) Meets the requirements of this subtitle and all rules and regulations adopted under this subtitle.

(d) An applicant who is denied a license is entitled to:

  (1) A hearing before the Secretary under Sec. 21-316 of this subtitle; and

  (2) Judicial review under Sec. 21-317 of this subtitle.

#### Section 21-312

Each licensee shall display the license conspicuously in the food establishment.

#### Section 21-312.1

(a)

  (1) In this section the following words have the meanings indicated.

  (2) "Caterer" means a food service facility that offers catering services or identifies itself as a caterer.

  (3) "Catering services" means the preparation or provision and the serving of food or drink by a food service facility for service at the provider's premises or elsewhere in connection with a specific event or a business or social function or affair.

(b) A food service facility that offers catering services or that identifies itself as a caterer shall include its food service facility license number, including the identity of the issuer of the license, on:

  (1) All advertising on business cards, published print media, flyers, brochures, and any vehicles used in connection with catering services and in telephone directories; and

  (2) All contracts for catering services.

(c) A food service facility that is licensed in more than one political subdivision may satisfy the requirements of this section by displaying the food service facility license number of any or all of its licenses issued by one or more of the political subdivisions.

(d) This section does not apply to a person who:

  (1) Prepares food in a kitchen of another person's private home for service in that private home; or

  (2) Prepares food in a kitchen of a private home or a kitchen of a school, religious or charitable organization, or nonprofit institution for service or sale to benefit a school, religious or charitable organization, or nonprofit institution.

#### Section 21-312.2

(a) This section applies to a semipermanent food service facility that:

  (1) Operates in Anne Arundel County; and

  (2) Was licensed under Sec. 21-305 of this subtitle on or before December 1, 2010.

(b) An operator of a semipermanent food service facility shall:

  (1) Pump out the onboard wastewater holding tank as frequently as required by Anne Arundel County to avoid creating a public health nuisance;

  (2) Remove wastewater by:

    (i) Hiring a licensed liquid waste hauler to dispose of the wastewater; or

    (ii) Disposing of the wastewater at a wastewater disposal facility approved by Anne Arundel County;

  (3) Use a food grade hose and an adequate backflow prevention device to maintain a potable water supply; and

  (4) Demonstrate compliance with items (1) and (2) of this subsection by quarterly submitting a record of receipts to the issuer of the license.

#### Section 21-313

(a) To enforce this subtitle, a representative of the Department, at any reasonable time, may:

  (1) Enter and inspect any food establishment; and

  (2) Inspect and sample any item of food that is in a food establishment.

(b) A person may not:

  (1) Refuse to grant access to a representative of the Department who requests to enter and inspect a food establishment under this section; or

  (2) Interfere with any inspection under this section.

#### Section 21-314

If the Department finds that a food establishment is in violation of this subtitle or any rule or regulation adopted under this subtitle, is in an unsanitary condition, or is not equipped properly, the Secretary shall notify the licensee:

(1) Of the specific findings;

(2) Of a specific, reasonable date by which the licensee shall correct the violations or deficiencies specified in the notice; and

(3) That, if the licensee fails to correct the conditions by the date specified, the Department may suspend or revoke the license issued under this subtitle.

#### Section 21-315

The Department may suspend or revoke a license issued under this subtitle if the licensee:

(1) Violates or fails to meet the requirements of this subtitle or any regulation adopted under this subtitle; or

(2) Fraudulently or deceptively obtains a license.

#### Section 21-316

(a) Except as otherwise provided in Title 10, Subtitles 2 and 3 of the State Government Article, before the Department takes any final action under Sec. 21-311 or Sec. 21-315 of this subtitle, the Secretary shall give the person against whom the action is contemplated an opportunity for a hearing before the Department.

(b) The Department shall give notice and hold the hearing in accordance with Title 10, Subtitle 2 of the State Government Article.

(c) The Department shall send the hearing notice to the applicant or licensee by certified mail, return receipt requested, bearing a postmark from the United States Postal Service.

(d) Within 30 days after the hearing required under this section, the Department shall decide the issue and immediately notify the parties to the hearing.

#### Section 21-317

(a) Any person aggrieved by a final decision of the Department in denying, suspending, or revoking a license issued under this subtitle may take a direct judicial appeal.

(b) The appeal shall be made as provided for judicial review of final decisions in Title 10, Subtitle 2 of the State Government Article.

(c) Either party may appeal the decision of the circuit court to the Appellate Court of Maryland.

#### Section 21-318

(a) If the Department believes that a person is violating any provision of this subtitle or any regulation adopted under this subtitle, the Department may have the person served with a written order that directs the person served to abate the violation within a time specified in the order.

(b) Except as otherwise provided in Title 10, Subtitle 2 of the State Government Article, the Department shall give any person served with an order under this section an opportunity for a hearing before the Department.

(c) After a hearing under this section, the Department may affirm, modify, or withdraw the order.

(d) A person who is served with an order under this section may not violate that order.

#### Section 21-321

(a) Except as provided in subsection (d) of this section, before a food establishment is constructed, remodeled, or materially altered, or before an existing building or structure is converted or remodeled for use as a food establishment, properly prepared plans and specifications for the construction, remodeling, or alteration of a food establishment shall be submitted to:

  (1) The Department, if the food establishment is:

    (i) A food processing plant; or

    (ii) A chain or franchise food service facility planning to construct 2 or more facilities in the State from a single uniform set of plans; or

  (2) Except as provided in item (1)(ii) of this subsection, for food service facilities, to the appropriate county health department.

(b) The plans or specifications required under subsection (a) of this section shall include:

  (1) Layout and arrangement of work areas;

  (2) Construction materials;

  (3) The location, size, manufacturer, and model number of equipment and facilities; and

  (4) Any other information that may be required for the proper review of the plans and specifications.

(c) Unless the required plans and specifications are approved by the Department, a person may not:

  (1) Construct, remodel, or alter a food establishment; or

  (2) Convert or remodel an existing building or structure for use as a food establishment.

(d) The provisions of this section do not apply to the construction, remodeling, or alteration of any areas in a food establishment used solely for office space, or recreational areas.

#### Section 21-322

(a) The Maryland Department of Health and the State Department of Agriculture may:

  (1) Inspect for wholesomeness any food donated to a nonprofit corporation, organization, or association; and

  (2) Establish procedures for handling food donated to any nonprofit corporation, organization, or association.

(b)

  (1) In this subsection, "person" shall include a nonprofit corporation, organization, or association.

  (2) A person shall have the immunity from liability described under Sec. 5-634 of the Courts Article for any act or omission that affects the nature, age, condition, or packaging of the donated food.

#### Section 21-323

(a) In this section, "group home" means a foster home, emergency shelter, or family type residential facility for children that is:

  (1) Sponsored by a public or private agency; and

  (2) Supervised by foster parents, house parents, or counselors.

(b) Any group home is exempt from any regulation governing food service facilities that is adopted by the Department or a local government, if the group home:

  (1) At no time has more than 14 residents including house parents and supervisory, professional, and custodial staff members; and

  (2) Has among its resident children only children placed in the group home by a court, a licensed child placement agency, or a government agency, including a local department of social services.

(c) Each group home that is intended for no more than 14 residents shall be registered with the health officer for the county and is subject to State and local health regulations that govern occupancy and use of private family homes.

(d) In each county, the health officer shall inspect each group home that is intended for no more than 14 residents.

#### Section 21-323.1

(a) In this section, "bed and breakfast establishment" means a lodging or rooming house as defined in Sec. 9-201 of the Public Safety Article having eight rooms or fewer for rent.

(b) A bed and breakfast establishment is exempt from any regulation governing food service facilities that is adopted by the Department or a local government relating to the construction or installation of commercial grade kitchen equipment in the bed and breakfast establishment.

(c) Each bed and breakfast establishment that intends to serve hot meals to renters shall be:

  (1) Licensed in accordance with Sec. 21-305 of this subtitle; and

  (2) Subject to State and local health regulations that govern food safety and contamination.

(d) In each county, the health officer shall inspect each bed and breakfast establishment that intends to serve hot meals to renters for compliance with food safety and contamination regulations in accordance with Sec. 21-313 of this subtitle.

#### Section 21-324

(a)

  (1) The floors, walls, ceilings, sidewalks, furniture, receptacles, implements, and machinery of or in any food establishment shall be kept in a clean and sanitary condition at all times.

  (2)

    (i) The design and construction of existing equipment in food establishments shall be accepted by the Department, if the existing equipment:

      (1) Complied with the Department's standards that prevailed at the time of the installation;

      (2) Accomplishes its intended and required function in the establishment;

      (3) Is cleanable;

      (4) Is free of hazardous materials and toxic food contact surfaces; and

      (5) Is in good repair.

    (ii) The Department shall establish guidelines for the replacement of failed existing equipment.

(b) Any vehicle that is used to transport food or from which any food is sold shall be kept in a clean and sanitary condition at all times.

(c) A condition that is unclean and unsanitary exists whenever any of the following occurs:

  (1) Any food in the process of manufacture, preparation, packing, canning, freezing, storing, sale, distribution, or transportation is not protected as far as practicable from flies, filth, and any foreign or injurious contamination;

  (2) Refuse, dirt, or waste products subject to decomposition and fermentation that are incident to the manufacture, preparation, packing, canning, freezing, storing, sale, distribution, or transportation of food are not removed daily, or at a frequency required by the Department;

  (3) Any receptacle, chute, platform, rack, table, shelf, utensil, or machinery used in moving, handling, cutting, chopping, mixing, canning, freezing, or processing food is not kept clean;

  (4) The clothing or body of any individual employed in the establishment, place, or vehicle is not kept as clean as the nature of the employment permits;

  (5) The food establishment lacks an adequate supply of potable water; or

  (6) The food establishment lacks an adequate sewage disposal facility.

#### Section 21-324.1

(a) This section does not apply to an outer door of a food service facility that leads from the kitchen to the outside.

(b) A food service facility may operate with the outer windows or outer doors open unless, while the food service facility is operating with the outer doors or outer windows open, the local health department:

  (1) Finds evidence of vermin in food preparation or food storage areas; or

  (2) Finds evidence of flying insects in food preparation or food storage areas that pose a significant threat to sanitation or public health.

(c) If a local health department finds that a food service facility is operating in violation of subsection (b) of this section, the food service facility shall take immediate action to eliminate the vermin or flying insects.

(d) A local health department may close a food service facility found to be operating in violation of subsection (b) of this section, or order a temporary closure of the outer windows and outer doors at the food service facility, until the vermin or flying insects are eliminated from the food preparation or food storage areas, or until another action approved by the local health department is taken.

(e) A food service facility found to be operating in violation of subsection (b) of this section on three or more separate occasions shall keep the outer windows and outer doors closed at all times until:

  (1) Modifications approved by the local health department are made to the food service facility to effectively protect against the entrance of vermin and flying insects; or

  (2) Another action approved by the local health department is taken.

#### Section 21-325

(a) Subject to subsection (d) of this section, each food establishment shall have:

  (1) A convenient toilet that is:

    (i) Except as provided in subsection (c) of this section, separated from any room in which food is manufactured, prepared, packed, canned, frozen, sold, or distributed;

    (ii) Kept in a sanitary condition; and

    (iii) Properly ventilated; and

  (2) A convenient lavatory that is:

    (i) Supplied with soap, water, towels, or other approved hand drying devices;

    (ii) Kept in a sanitary condition; and

    (iii) Properly ventilated.

(b)

  (1) This subsection does not apply to a mobile food service facility or a semipermanent food service facility located in Washington County.

  (2) Each food service facility which prepares food and provides seating for patrons established after January 1, 1979, shall have available for the public:

    (i) A convenient toilet that is kept in a sanitary condition; and

    (ii) A convenient lavatory that is:

      (1) Supplied with soap, water, towels, or other approved hand drying devices;

      (2) Kept in a sanitary condition; and

      (3) Properly ventilated.

(c) A room that houses a toilet may be constructed within a larger room in which food is manufactured, prepared, packed, canned, frozen, sold, or distributed.

(d)

  (1) This subsection applies only to a food establishment that is:

    (i) A business that conducts agritourism, as defined in Sec. 4-212 of the Land Use Article;

    (ii) A Class 4 limited winery licensed under Sec. 2-206 of the Alcoholic Beverages and Cannabis Article; and

    (iii) A Class 8 farm brewery licensed under Sec. 2-210 of the Alcoholic Beverages and Cannabis Article.

  (2) A food establishment may comply with the requirement to provide a convenient lavatory by providing a portable toilet that:

    (i) Otherwise meets the requirements of subsection (a)(2) or (b)(2)(ii) of this section; and

    (ii) Is placed at least 25 feet from a well.

#### Section 21-326

(a) Each food service facility which prepares food and provides seating for patrons shall post a diagram or illustrative directions on the use of manual maneuvers to prevent asphyxiation due to choking.

(b) A person who applies the maneuvers depicted in a diagram posted under this section to remove food lodged in the throat of another is liable only if the person's actions amount to gross negligence.

#### Section 21-327

A person may not sleep in:

(1) Any workroom or food storage room of a food processing plant; or

(2) Any kitchen, dining room, or food storage room of a food service facility.

#### Section 21-328

(a) A person may not knowingly employ any individual to work in any area or capacity in a food establishment in which there is a likelihood of transmission of disease to patrons or other employees of the food establishment if the individual employed:

  (1) Has a communicable disease that may be transmitted by food; or

  (2) Is a carrier of a communicable disease that may be transmitted by food.

(b) An individual may not knowingly work in any area or capacity in a food establishment in which there is a likelihood of transmission of disease to patrons or other employees of the food establishment if the individual:

  (1) Has a communicable disease that may be transmitted by food; or

  (2) Is a carrier of a communicable disease that may be transmitted by food.

#### Section 21-329

(a) Unless the packaging of a food product is clearly and conspicuously labeled in accordance with subsection (c) of this section, no food product containing or consisting of surimi may be sold in the State.

(b) Unless all menus and notices advertising a food containing or consisting of surimi are clearly and conspicuously labeled in accordance with subsection (c) of this section, a food service facility may not serve the food in the State.

(c) Labeling for a food product or food containing or consisting of surimi shall include 1 or more of the following terms, as appropriate:

  (1) "Imitation crab";

  (2) "Imitation lobster";

  (3) "Imitation scallops";

  (4) "Imitation shrimp";

  (5) "Imitation" followed by the name of the seafood imitated;

  (6) "Artificial processed seafood";

  (7) "Surimi";

  (8) "Seafood salad containing imitation" followed by the name of the seafood imitated; or

  (9) Other terms approved by the Department.

(d) In addition to the penalties set forth in Sec. 21-1214 of this title, the Secretary may seize or condemn any food product or food sold or served in violation of this section.

#### Section 21-330

(a) A low calorie frozen dessert that contains powders or dry mixes of pasteurized whey, reduced mineral whey, whey protein concentrate, reduced lactose whey, or optional caseinates and is rehydrated with potable water before freezing is not required to be repasteurized.

(b) The wheys, caseinates, or egg ingredients that are used in the formulation of a mixture under subsection (a) of this section shall:

  (1) Have been pasteurized before being used in the mixture; and

  (2) Contain only those ingredients that:

    (i) Are recognized as safe by the United States Food and Drug Administration; or

    (ii) Are authorized under regulations adopted under this subtitle.

(c) After the rehydration of a mixture under subsection (a) of this section, the mixture shall be:

  (1) Cooled to a maximum temperature of 45 degrees Fahrenheit within 4 hours; and

  (2) Frozen within 24 hours.

(d) The Secretary shall adopt regulations that comply with the provisions of this section.

#### Section 21-330.1

(a) This section does not:

  (1) Apply to a food establishment that is required to have a license under Sec. 21-305 of this subtitle; or

  (2) Exempt a cottage food business from any applicable State or federal tax laws.

(b) A cottage food business is not required to be licensed by the Department if the owner of the cottage food business complies with this section.

(c) The owner of a cottage food business may sell only cottage food products that are:

  (1) Stored on the premises of the cottage food business; and

  (2) Prepackaged with a label that contains:

    (i) The following information:

      (1)

        (A) The name and address of the cottage food business; or

      (B) The name and phone number of the cottage food business and the identification number assigned to the cottage food business under subsection (d) of this section;

      (2) The name of the cottage food product;

      (3) The ingredients of the cottage food product in descending order of the amount of each ingredient by weight;

      (4) The net weight or net volume of the cottage food product;

      (5) Allergen information as specified by federal labeling requirements; and

      (6) If any nutritional claim is made, nutritional information as specified by federal labeling requirements;

    (ii) The following statement printed in 10 point or larger type in a color that provides a clear contrast to the background of the label: "Made by a cottage food business that is not subject to Maryland's food safety regulations."; and

    (iii) For a cottage food product offered for sale at a retail food store:

      (1) The phone number and e-mail address of the cottage food business; and

      (2) The date the cottage food product was made.

(d) At the request of a cottage food business, the Department shall provide to the cottage food business a unique identification number that the cottage food business may use on the label of a cottage food product under subsection (c) of this section.

(e) The owner of a cottage food business shall comply with all applicable county and municipal laws and ordinances regulating the preparation, processing, storage, and sale of cottage food products.

(f)

  (1) The Department may investigate any complaint alleging that a cottage food business has violated this section.

  (2) On receipt of a complaint, a representative of the Department, at a reasonable time, may enter and inspect the premises of a cottage food business to determine compliance with this section.

  (3) The owner of a cottage food business may not:

    (i) Refuse to grant access to a representative who requests to enter and inspect the premises of the cottage food business under paragraph (2) of this subsection; or

    (ii) Interfere with any inspection under paragraph (2) of this subsection.

  (4) An investigation of a cottage food business conducted under this subsection may include sampling of a cottage food product to determine if the cottage food product is misbranded or adulterated.

(g) Before the owner of a cottage food business may sell a cottage food product to a retail food store, the owner shall submit to the Department:

  (1) Documentation of the owner's successful completion of a food safety course approved by the Department; and

  (2) The label that will be affixed to the cottage food product in accordance with subsection (c)(2) of this section.

(h) Beginning on or before December 30, 2020, and every December 30 thereafter, the Department shall report to the Senate Finance Committee and the House Health and Government Operations Committee, in accordance with Sec. 2-1257 of the State Government Article, on:

  (1) The documentation and labels submitted under subsection (f) of this section; and

  (2) Any complaints received by the Department related to a cottage food business or cottage food product.

(i) The Department shall adopt regulations to carry out this section.

#### Section 21-330.2

(a) Beginning March 1, 2014, a food establishment shall display prominently in the staff area of the food establishment a poster relating to food allergy awareness that includes information regarding the risk of an allergic reaction.

(b) On or before January 1, 2014, the Department, in consultation with the Restaurant Association of Maryland and Food Allergy Research and Education, shall create and make available on its website the poster required to be displayed under subsection (a) of this section.

#### Section 21-330.3

(a)

  (1) In this section the following words have the meanings indicated.

  (2) "Automated external defibrillator (AED)" means a medical heart monitor and defibrillator device that:

    (i) Is cleared for market by the federal Food and Drug Administration;

    (ii) Recognizes the presence or absence of ventricular fibrillation or rapid ventricular tachycardia;

    (iii) Determines, without intervention by an operator, whether defibrillation should be performed;

    (iv) On determining that defibrillation should be performed, automatically charges; and

    (v)

      (1) Requires operator intervention to deliver the electrical impulse; or

      (2) Automatically continues with delivery of the electrical impulse.

  (3) "Grocery store" means a store that has:

    (i) All major food departments, including produce, meat, seafood, dairy, and canned and packaged goods; or

    (ii)

      (1) At least one of the major food departments; and

      (2) At least 12,000 square feet of floor space.

(b) This section does not apply to:

  (1) A grocery store that has an annual gross income of $10,000,000 or less; or

  (2) A restaurant with:

    (i) An annual gross income of $1,000,000 or less, exclusive of sales for off-premises consumption; or

    (ii) A seating capacity of less than 100 individuals.

(c) Each owner and operator of a grocery store or restaurant shall:

  (1) Place an automated external defibrillator in a prominent area, accessible to employees and customers;

  (2) Maintain the functionality of the automated external defibrillator; and

  (3) Comply with the applicable requirements of the Public Access Automated External Defibrillator Program provided under Sec. 13-517 of the Education Article.

(d) In addition to any other immunities available under statutory or common law:

  (1) A grocery store or restaurant is not civilly liable for any act or omission in the provision of automated external defibrillation if the grocery store or restaurant has satisfied the requirements under this section;

  (2) An individual is not civilly liable for any act or omission if:

    (i) The individual is acting in good faith while rendering automated external defibrillation to another individual who is a victim or reasonably believed by the individual to be a victim of a sudden cardiac arrest;

    (ii) The assistance or aid is provided in a reasonably prudent manner; and

    (iii) The automated external defibrillation is provided without fee or other compensation; and

  (3) A grocery store, restaurant, or individual is not civilly liable for failing to render automated external defibrillation to an individual who is a victim or is reasonably believed to be a victim of a sudden cardiac arrest.

(e) The Department and the Maryland Institute for Emergency Medical Services Systems jointly shall adopt regulations that:

  (1) Establish guidelines for periodic inspections and annual maintenance of the automated external defibrillators;

  (2) Assist the owner and operator of a grocery store or restaurant in carrying out the provisions of this section; and

  (3) Require each grocery store and restaurant subject to this section to register with the Maryland Institute for Emergency Medical Services Systems in order to:

    (i) Make its location publicly available to emergency dispatchers; and

    (ii) Receive maintenance and recall notices from the Maryland Institute for Emergency Medical Services Systems.

#### Section 21-330.4

(a)

  (1) In this section the following words have the meanings indicated.

  (2)

    (i) "Baby food" means food packaged in a jar, pouch, tub, or box sold specifically for babies and children under the age of 2 years.

    (ii) "Baby food" does not include infant formula, as defined in 21 U.S.C. Sec. 321(z).

  (3) "Manufacturer" includes a food manufacturer, food processor, and food packer.

  (4) "Production aggregate" means a quantity of product that is intended to have uniform composition, character, and quality and is produced according to a master manufacturing order.

  (5) "Proficient laboratory" means a laboratory that:

    (i) Is accredited under the standards of the International Organization for Standardization/International Electrotechnical Commission 17025:2017;

    (ii) Uses an analytical method at least as sensitive as the analytical method described in Section 4.7 of the U.S. Food and Drug Administration Elemental Analysis Manual for Food and Related Products; and

    (iii) Demonstrates proficiency in quantifying each toxic element to at least 6 micrograms of the toxic element to kilogram of food through an independent proficiency test by achieving a z-score that is less than or equal to plus or minus two.

  (6) "QR code" means a machine-readable code, consisting of an array of squares, used for storing an Internet website in order to access a webpage.

  (7) "Representative sample" means a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled.

  (8) "Toxic heavy metal" means arsenic, cadmium, lead, or mercury.

(b)

  (1) Except as provided in paragraph (2) of this subsection, on or after January 1, 2025, a person may not sell, distribute, or offer for sale baby food in the State that contains toxic heavy metals that exceed the limits established by the U.S. Food and Drug Administration.

  (2) A person may sell, distribute, or offer for sale baby food manufactured before January 1, 2026.

(c)

  (1) Beginning January 1, 2025, each manufacturer of baby food shall test a representative sample of each production aggregate of the manufacturer's final baby food product for each toxic heavy metal.

  (2) The testing required under paragraph (1) of this subsection shall be conducted by a proficient laboratory at least once per month.

  (3) A manufacturer may test the final baby food product in accordance with paragraph (1) of this subsection before packaging individual units of baby food for sale or distribution.

(d) On the request of the Department, a manufacturer of baby food shall provide the results of the testing conducted under subsection (c) of this section to an authorized agent of the Department.

(e) Beginning January 1, 2026, each manufacturer of baby food shall:

  (1) Make publicly available on the manufacturer's website for each baby food product sold, manufactured, delivered, held, or offered for sale in the State:

    (i) The name and level of each toxic heavy metal present in the final baby food product as determined by the testing conducted under subsection (c) of this section;

    (ii) Sufficient information, such as the product name, universal product code, or lot or batch number, to enable consumers to identify the final baby food product; and

    (iii) A link to the U.S. Food and Drug Administration's website that includes the most recent U.S. Food and Drug Administration guidance and information about the health effects of the toxic heavy metals on children; and

  (2) If the baby food is tested for a toxic heavy metal subject to an action level, regulatory limit, or tolerance established by the U.S. Food and Drug Administration under 21 C.F.R. Sec. 109, include on the baby food product label:

    (i) The following statement: "For information about toxic element testing on this product, scan the QR code."; and

    (ii) A QR code or other machine-readable code that allows consumers to access on the manufacturer's website or the baby food product information page:

      (1) The test results for the toxic heavy metals; and

      (2) A link to the webpage on the U.S. Food and Drug Administration website that includes the most recent guidance and information about the health effects of the toxic heavy metal on children.

(f) If a consumer believes, based on information gathered through the use of the code included on the baby food product label under subsection (e)(2) of this section, that baby food is being sold in the State with toxic heavy metals that exceed limits established by the U.S. Food and Drug Administration, the consumer shall report the baby food to the Department.

#### Section 21-332

The Department shall renew, deny, suspend, or revoke a soft drink registration as provided for the renewal, denial, suspension, or revocation of a license under Sec.Sec. 21-309, 21-311, 21-314, 21-315, 21-316, 21-317, and 21-318 of this subtitle.

#### Section 21-333

In this State, a person may not sell a soft drink manufactured outside of this State unless the soft drink has been registered with the Department.

#### Section 21-334

(a) This section applies to any container that is used to pack, store, distribute, or sell:

  (1) A soft drink; or

  (2) Bottled water.

(b) Before putting a soft drink or bottled water in a container, a manufacturer shall clean the container in a manner approved by the Department or shall use clean containers.

#### Section 21-335

(a) A person may not sell or offer for sale at retail in this State any metal soft drink container or any composite soft drink container that is designed and constructed with an all metal tab opening device that detaches from the container when the container is opened in a manner which is normally used to empty the contents of the container.

(b) The provisions of this section do not prohibit the sale or offer for sale of:

  (1) A beverage container sealed with a laminated tape seal, even if the seal contains aluminum foil, if the seal is not rigid;

  (2) Frozen beverage concentrates in all metal containers with detachable metal pull tabs customarily and primarily purchased for dilution and use within the home, or for similar purposes; and

  (3) Metal beverage containers with pull tabs for milk-based products, soy-based products, or similar products which require sterilization and pressure in the canning process.

#### Section 21-336

(a)

  (1) In this section, "approved source" means a source of water that is:

    (i) Sampled and found through laboratory analysis to comply with:

      (1) The microbiological standards adopted by the Department, with testing on a monthly basis; and

      (2) The chemical and radiological standards adopted by the Department, which shall meet or exceed the standards prescribed by the federal Food and Drug Administration, with testing annually for chemical analyses and once every 4 years for radiological analyses; and

    (ii) If applicable, constructed and inspected in accordance with regulations adopted by the Department of the Environment under Sec.Sec. 9-204, 9-1305, and 9-1306 of the Environment Article.

  (2) "Approved source" includes:

    (i) An artesian well;

    (ii) A drilled well;

    (iii) A glacier;

    (iv) A public water supply;

    (v) A spring; and

    (vi) A source of mineral water that complies with the standards specified in paragraph (1) of this subsection but fails to meet the standards with respect to those properties of mineral water related to the limitations on chloride, iron, manganese, sulfate, total dissolved solids, zinc, or any other exemptions listed under 21 C.F.R. 165.110.

  (3) The Department may approve a source that does not meet standards regulated by the United States Environmental Protection Agency as a secondary standard if the bottler shows by analysis that a particular treatment used reduces the level of contaminants in the bottled water to a level below the maximum contaminant level.

(b) The requirements of this section are in addition to any other provision of law.

(c) Artesian water, mineral water, natural water, purified water, spring water, well water, and any other type of bottled water shall meet the requirements of the standard of identity for bottled water under 21 C.F.R. 165.110(a).

(d)

  (1) A person may not bottle water unless the person is licensed by the Department under Sec. 21-305 of this subtitle.

  (2) The Department may not issue a license if the Department determines that the water is:

    (i) Not from an approved source; or

    (ii) In any way injurious to the public health.

  (3) To apply for a license to bottle water, a bottler shall:

    (i) Submit an application to the Department on the form that the Department requires;

    (ii) List on the application form the types of bottled water that the applicant proposes to bottle; and

    (iii) Pay to the Department an annual fee established by the Secretary under Sec. 2-104 of this article.

  (4) While it is effective, a license to bottle water authorizes a bottler to bottle and sell in the State the types of bottled water identified in the license.

(e)

  (1)

    (i) A person who is licensed under this section shall submit to the Department the results of:

      (1) Annual chemical and radiological analyses of a representative sample of the person's source water and bottled water; and

      (2) A monthly microbiological analysis of a representative sample of the source water and bottled water.

    (ii) The analyses shall demonstrate that the source water and bottled water comply with the chemical, radiological, and microbiological standards adopted by the Department, which shall meet or exceed the standards prescribed by the federal Food and Drug Administration.

    (iii)

      (1) Except as otherwise required by law, mineral water is not subject to the limitations on chloride, iron, manganese, sulfate, total dissolved solids, zinc, or any other exemptions listed under 21 C.F.R. 165.110.

      (2) Bottled water may not exceed:

      (A) 10 parts per billion of total trihalomethanes;

      (B) 5 parts per billion of lead; or

      (C) 100 parts per billion of chlorine.

  (2)

    (i) Analyses required under this subsection may be performed by a laboratory certified by:

      (1) A state's Laboratory Certification Program in accordance with the United States Environmental Protection Agency's primacy conditions under the Agency's Public Water System Supervision Program; or

      (2) The United States Environmental Protection Agency.

    (ii) The Department shall accept analyses performed by any laboratory authorized under subparagraph (i) of this paragraph.

  (3) A person licensed or registered under this section shall:

    (i) For at least 2 years, maintain all inspection and sampling records at the person's principal place of business; and

    (ii) Make inspection and sampling records available to the Department upon request.

  (4) Notwithstanding the analyses required under paragraph (1) of this subsection, the Department may sample and analyze any bottled water.

  (5) The provisions of this subsection do not prevent the Department from prohibiting the use or sale of bottled water in the State, if, in the judgment of the Department:

    (i) The water is shown by analysis to be unfit for drinking;

    (ii) The water has been misbranded under Sec. 21-210 of this title; or

    (iii) Its quality is in any way injurious to the public health.

(f) Bottled water in individual containers shall be marked on each container with a stencil, stamp, or label that clearly indicates:

  (1) The identifying batch code for the water; and

  (2) In compliance with subsection (g) of this section, the type of water and any additional ingredients.

(g) Labeling of the type of bottled water and any additional ingredients, as required under subsection (f) of this section, shall conform to the labeling requirements for bottled water under 21 C.F.R. 165.110(a).

(h) In accordance with regulations adopted by the Department, a person licensed under this section shall establish written procedures and implement those procedures to:

  (1) Prevent contamination during the processing, packaging, transportation, or storage of bottled water; and

  (2) Recall bottled water when the person, the Department, or any other government agency determines that a supply is injurious in any way to the public health.

(i) The Department may suspend or revoke a license issued under this section if the licensee:

  (1) Violates or fails to satisfy any requirement of this title or any regulation adopted under this title; or

  (2) Fraudulently or deceptively obtains a license.

(j)

  (1) In addition to any other penalty applicable at law, a person who violates any provision of this section shall be liable for a civil penalty of:

    (i) Not less than $1,000 and not more than $5,000 for a first offense; and

    (ii) Not less than $5,000 and not more than $10,000 for a second offense within 2 years of the first offense.

  (2) Each day on which a violation occurs constitutes a separate offense.

(k) By October 1, 2008, the Department shall adopt regulations to implement the provisions of this section.

(l)

  (1) The Department shall establish a Bottled Water Advisory Committee to advise and assist the Department in the development and adoption of the regulations required under subsection (k) of this section.

  (2) The Advisory Committee shall consist of the following representatives:

    (i) The Secretary of Health or the Secretary's designee, who shall serve as chairman of the Advisory Committee;

    (ii) The Secretary of the Environment or the Secretary's designee;

    (iii) A hydrogeologist;

    (iv) At least two individuals from the bottled water processing industry;

    (v) At least one individual from the bottled water distribution industry;

    (vi) At least one individual from the environmental community or consumer advocacy community; and

    (vii) At least one consumer of bottled water.

#### Section 21-336.1

(a) Except as permitted under subsection (b) of this section, bottled water shall:

  (1) Be obtained from an approved source; and

  (2) Undergo:

    (i) Ozonation or an equivalent disinfection process approved by the Department; and

    (ii) When required by the Department, filtration or any other treatment that is necessary for the water to comply with the standards adopted by the Department under Sec. 21-336(e)(1)(ii) of this subtitle.

(b) The Department may grant to a bottler a waiver of the filtration and disinfection treatment required under subsection (a) of this section if the Department is satisfied that the filtration and disinfection treatment are not necessary to assure that a bottled water product will consistently comply with the microbiological standards under this subtitle.

(c)

  (1) Based on the bottler's demonstration of long-term baseline microbiological data that monitors the source and the product, the nature and extent of source monitoring, and source protection and bottling sanitation procedures instituted by the bottler, a waiver may be granted if:

    (i) The product and source are in compliance with the Codex Alimentarius standard for natural mineral water, CAC/RS 108, as amended, and the requirements under Sec. 21-336(a)(2) and (e) of this subtitle;

    (ii) The product and source are in compliance with the Code of Hygienic Practice of the Codex Alimentarius, Alinorm 85/13A, as amended, for the collection, processing, and marketing of natural mineral water; and

    (iii) The bottler has submitted a basic hydrogeological survey of the source, a hydrogeological assessment that demonstrates that the source is not under the direct influence of surface water, and an annual sanitary survey, all of which have been prepared by a professionally qualified hydrogeologist and which demonstrate the integrity of the source.

  (2) The annual sanitary survey required under paragraph (1)(iii) of this subsection shall include:

    (i) Watershed surveillance that includes an inspection of those portions of the drainage area necessary to identify and evaluate actual and probable sources of contamination;

    (ii) Evaluation of source construction and protection, and, when appropriate, intake structures and transmission facilities; and

    (iii) Evaluation of finished water storage facilities.

(d) Once a waiver has been granted under this section:

  (1) A bottler shall renew the waiver of the filtration and disinfection treatment provided under subsection (b) of this section on an annual basis if a continuation of operations is desired by submitting a letter of compliance with subsection (c) of this section from a representative of the bottler to the Department.

  (2) The representative of the bottler shall certify under personal knowledge and penalty of perjury that the conditions under subsection (c) of this section on which the waiver was granted have not changed.

  (3) The representative of the bottler shall have a continuing obligation to notify the Department of any change of a condition under subsection (c) of this section not later than 5 days from the date of the change.

  (4) The product shall be bottled:

    (i) In an enclosed filling room or chamber that is under positive pressure of filtered purified air; and

    (ii) At a facility and with good manufacturing practices that comply with the requirements of 21 C.F.R. Part 129.

(e) If a bottled water product is not in compliance with any requirement under subsection (c) or (d) of this section:

  (1) The Department shall revoke the waiver; and

  (2) The product shall be subject to the filtration and disinfection treatment requirements under subsection (a) of this section.

(f) Except for filtration and disinfection treatment, this section may not be construed to waive any requirement that is applicable under this subtitle to a bottled water product.

#### Section 21-339

(a) In this section, "repack crab meat" means to take or remove crab meat from any container or package, when the crab meat has been picked from a crab at another location, and place that crab meat in another container or package.

(b) Each container of crab meat shall be marked plainly with the information required by this section.

(c)

  (1) Each container of crab meat shall be marked by:

    (i) Embossing;

    (ii) Imprinting;

    (iii) Lithography; or

    (iv) Subject to paragraph (2) of this subsection, any other method that the Department approves.

  (2) Unless approved by the Secretary, a container of crab meat may not be stamped with ink.

(d)

  (1) Each container of crab meat shall be marked with:

    (i) A description of the product in the container;

    (ii) Subject to the requirements of paragraph (2) of this subsection, the name and address of the picking plant or the distributor;

    (iii) If a chemical is added to the crab meat, a statement to that effect;

    (iv) The license number of the crab meat plant preceded by the State abbreviation applicable to the picking plant;

    (v) The net weight of the contents of the container; and

    (vi) Any other information that the Department requires.

  (2) If a container of crab meat is marked with the name of the distributor, the name of the distributor shall be:

    (i) Preceded by the words "packed for" or "distributed by"; or

    (ii) Followed by the word "distributor".

(e) A person may not put any false or misleading statement on a container of crab meat.

(f)

  (1) A person may not repack crab meat or change crab meat containers or container lids with the intent to sell the crab meat except as provided by the Department.

  (2)

    (i) A person may not possess more than 12 empty crab meat containers or container lids unless the person:

      (1) Is a manufacturer of containers or lids;

      (2) Is a licensed crab meat packer and the containers or lids are the same as used by the packer in the ordinary course of business;

      (3) Has removed the crab meat from the containers and lids for consumption on the premises; or

      (4) Is in possession of the containers or lids as provided for by the Department.

    (ii) Possession of empty containers or crab meat container lids in violation of this section shall be presumptive evidence of intent to repack crab meat in violation of this Part VI of this subtitle.

    (iii) Possession of crab meat containers or crab meat container lids from which the crab meat has been consumed or cooked for consumption and which have been properly disposed of may not constitute presumptive evidence of intent to repack or change crab meat containers for sale.

(g)

  (1) Notwithstanding any other provision of law, each container of crab meat sold in the State containing crab meat picked from a crab, packed, repacked, or processed outside of the United States shall be marked with the words "This product contains crab meat from (name of country of origin)".

  (2) The marking required by paragraph (1) of this subsection shall be prominently displayed in letters not smaller than 12-point type on the principal display panel of the container so as to be easily read by the consumer.

#### Section 21-340

All crab meat sold in this State, whether processed in a crab meat plant in this State or in a crab meat plant outside this State, shall comply with this subtitle and meet the standards set by the regulations adopted under this subtitle.

#### Section 21-341

(a) A person may not process, sell, or keep for sale, as crab meat, anything that is not crab meat.

(b) A person may not process or sell for human consumption crab meat that:

  (1) Contains any filthy, putrid, or decomposed substance or is otherwise unfit for human consumption;

  (2) Has been packed or pasteurized in violation of this subtitle; or

  (3) Has been packed, prepared, or held under conditions that may have allowed the crab meat to become:

    (i) Contaminated with filth; or

    (ii) Injurious to health.

(c)

  (1) A licensee may not possess, with intent to sell for human consumption, any crab meat, the processing or sale of which would be a violation of this section.

  (2) Possession by a licensee of any crab meat, the processing or selling of which would be a violation of this section, is presumptive evidence of intent to sell the crab meat for human consumption.

#### Section 21-343

The Secretary shall seize and condemn any crab meat that does not comply with this subtitle.

#### Section 21-346

Except for shellstock that is imported into this State for replanting under the direction of the Department of Natural Resources, or commercially sterile shellfish or shellfish products, a person may not import shellfish into this State unless the shellfish is from a source certified by the appropriate agency responsible for interstate shellfish shipment.

#### Section 21-347

(a) Unless the shellfish contained in the food comes from a source certified by the appropriate agency responsible for interstate shellfish shipment, a person may not import into this State any food that contains shellfish.

(b) Each processor of food that contains shellfish that is imported into this State shall:

  (1) Keep on file proof that the shellfish is from a source certified by the appropriate agency responsible for interstate shellfish shipment; and

  (2) Provide this proof to the Department on request.

#### Section 21-348

A person may not process, sell, or keep for sale any shellfish or any food that contains shellfish if the shellfish involved is from an unknown or uncertified source.

#### Section 21-349

The Department may:

(1) Detain and take any necessary action on any shipment of shellfish or any food that contains shellfish if the shellfish involved is from an unknown or uncertified source; and

(2) Condemn and destroy any shellfish or any food that contains shellfish if the shellfish involved is from an uncertified source.

#### Section 21-350

(a)

  (1) Any vehicle that is used to transport, store, or sell shellfish for commercial purposes or processed crabs for commercial purposes shall be capable of maintaining the shellfish or processed crabs at a temperature established by the Department.

  (2) This subsection does not apply to a licensed harvester of shellfish who delivers the shellfish in a vehicle to a processor, retailer, or wholesaler on the day of harvest.

(b) Any shellfish or processed crabs that are transported by, sold from, or stored in any vehicle for commercial purposes shall be maintained at a temperature established by the Department.

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Md. Code Ann., Health-Gen. (as displayed at mgaleg.maryland.gov, October 16, 2026)