Maryland

Regulated Medical Waste

Definition

of Special Medical Waste

• Special medical waste is a solid waste that is composed of:

Anatomical material, which is human or animal body parts, including tissues and organs;

• Blood (human or animal);

• Blood-soiled articles, which means any article that contains blood in any form as a result of contact with blood;

• Contaminated material which means:

• Microbiological laboratory waste;

• The feces of an individual diagnosed as having a disease that may be transmitted to another human being through the feces;

• An article soiled with the feces of an individual diagnosed as having a disease that may be transmitted to another human being through the feces; or

• An article that has come into contact with a known infectious agent.

• Microbiological laboratory waste, which means waste from a microbiological laboratory that contains an infectious agent and includes cultures and stocks of infectious agents and associated biologicals; or

• Sharps, which means a syringe, needle, surgical instrument, or other article that is capable of cutting or puncturing human skin.

Exclusions

The following solid wastes are not special medical wastes:

• Household waste;

• Wastes generated in the handling of an animal unless the generator knows or has reason to know that the animal has a disease that is capable of being transmitted to humans;

• The ash or by-product from an incinerator authorized by a state to burn special medical waste; and

• Wastes not generated in the ordinary course of business.

Except as otherwise provided in the regulations, if a person generates, in a calendar month, a total of less than 50 pounds of special medical wastes, those wastes are not subject to regulation.

If a person whose waste has been excluded from the regulations accumulates special medical wastes in quantities greater than 50 pounds, those accumulated wastes are subject to regulation.

In order for special medical waste to be excluded from regulation, the generator shall comply with all applicable regulations.

If a person sterilizes special medical wastes, those wastes are excluded from portions of the regulations.

Managing Special Medical Waste

Standards for generators of special medical waste

A generator who treats, stores, or disposes of special medical wastes on-site shall only comply with the following requirements with regards to that waste:

• Determining whether or not the generator has special medical waste;

• Obtaining an identification number;

• Record keeping;

• Additional reporting; and

• Applicable requirements of the U.S. Department of Transportation Hazardous Materials Regulations.

An owner or operator who initiates a shipment of special medical waste from a treatment, storage, or disposal facility shall comply with the generator standards established in this chapter.

Special Medical Waste Determination

A person who generates a solid waste, shall determine if that waste is a special medical waste by first determining if the waste is excluded from the regulations, and then determine if the waste is a special medical waste.

Maryland Identification Numbers

A generator may not treat, store, dispose of, transport, or offer for transportation, special medical waste without having received a Maryland identification number from the Secretary.

• A generator who has not received a Maryland identification number may obtain one by applying to the Secretary. Upon receiving the request the Secretary will assign an identification number to the generator.

• A generator may not offer his special medical waste to transporters that have not received a Maryland identification number.

Shipping Papers

A generator of special medical waste who transports, or offers for transportation, special medical waste for off-site treatment, storage, or disposal shall prepare shipping papers in accordance with the requirements of the regulations.

Pretreatment Requirements

• Packaging: Before transporting or offering for transport, the generator shall:

• Place blood or blood-soiled article in a container that will prevent blood from spilling or otherwise leaving the container;

• Place anatomical materials in a leak proof bag or bags with a combined thickness of at least 3 mils or equivalent strength, and place the bag or bags in a clearly labeled rigid container to protect the bag or bags from puncture;

• Place a sharp in a container which is impervious to puncture; and

• Comply with any regulation by the Secretary of Health and Mental Hygiene, and other applicable regulations that are intended to ensure safety in handling infectious agents.

• Labeling: Before transporting or offering special medical waste for transportation off-site, a generator shall:

• Label each package with the generator identification number and the words, “Special Medical Waste”; and

• Ensure that the label is clearly visible.

• Treating: If a generator treats special medical waste before transporting or offering for transport, then the generator may treat the special medical waste only as provided in the regulations.

• Disposal of Sharps: A generator may not dispose of sharps in a solid waste landfill unless the generator incinerates the sharps or first sterilizes and then mechanically destroys the sharps.

Handling, Treatment, and Disposal of Special Medical Waste

A person shall treat special medical waste, excluding sharps, before disposal; and use one of the following treatment methods:

• Autoclaving;

• Chemical disinfection;

• Cremation;

• Disinfection;

• Mechanical destruction after decontamination; or

• An alternative method that meets the criteria of the regulations.

A person shall treat sharps before disposal and by one of the following methods:

• Encapsulation;

• Incineration;

• Mechanical destruction after decontamination; or

• An alternative method that meets the criteria of the regulations.

Disposal

A person shall dispose of special medical waste after treatment by one of the following methods:

• Burying;

• Depositing in a facility approved by local ordinance to accept the type of solid waste being disposed; or

• Incineration.

A person may discharge a special medical waste that is liquid, semiliquid, or anatomical material that has been mechanically destroyed into a sewerage system, except as specifically prohibited by local ordinance or regulation.

A person shall dispose of special medical waste in accordance with local laws and regulations to the extent that the local requirements are not preempted by or in conflict with State law.

Record Keeping and Reporting

• Generators shall keep a copy of each annual report and exception report for a period of at least 3 years from the date of the report.

• Generators shall keep records of any test results, waste analyses, or other determinations made in accordance with the regulations for at least 3 years from the date that the waste was last sent to on-site or off-site treatment, storage, or disposal.

• The periods of retention are extended automatically during the course of any unresolved enforcement action regarding the regulated activity or as requested by the Secretary.

• Additional Reporting. The Secretary, as the Secretary deems necessary, may require generators to furnish additional reports concerning the quantities and disposition of special medical wastes.

International Shipments

A person who exports special medical waste to a foreign country or imports special medical waste from a foreign country into the State shall comply with the requirements of all applicable regulations.

Standards Applicable to Transporters of Special Medical Waste

These standards apply to persons transporting special medical waste within the State if the transportation requires a shipping paper. These regulations do not apply to on-site transportation of special medical waste by generators or by owners or operators of permitted special medical waste management facilities.

• A transporter may not transport special medical wastes without having received a State identification number from the Secretary.

• A person may not transport special medical waste to a facility within the State or from a source within the State unless the person obtains a certificate from the Department. A special medical waste hauler certificate is required of persons engaged in transporting special medical wastes.

• Transporters using vehicles or articulated transports to transport special medical waste to a facility within the State or from a source within the State shall:

• Display prominently the vehicle certificate; or

• Affix the vehicle certificate to the outside of the left door of the cab of the special medical waste vehicle.

Shipping Papers

A transporter of special medical waste may not accept the waste from a generator, unless a generator-prepared shipping paper accompanies the waste.

Delivery Requirements

The transporter shall deliver the entire quantity of special medical waste, which the transporter has accepted from a generator or a transporter to:

• The facility designated by the generator;

• An alternate facility designated by the generator, if the special medical waste cannot be delivered to the designated facility because an emergency prevents delivery;

• Next designated transporter; or

• Place outside the United States designated by the generator.

Special Medical Waste Discharge

If a discharge of special medical waste occurs during transportation, the transporter shall take appropriate immediate action to protect human health and the environment, and shall notify the Department and local authorities, if any, within one hour of the incident, or, if not immediately discovered, within one hour of discovery of the incident, by calling 410-974-3551.

OSHA Regulations

HERC

OSHA State Page

In addition to

the state medical waste environmental regulations there

are some

Occupational Safety and Health Administration (OSHA) rules

that apply to medical/infectious waste. Maryland

is one of 21 states

operating an approved occupational safety and health program.

This program is operated by

Maryland Occupational Safety and Health Division. OSHA

rules (Occupational Exposure to Bloodborne Pathogens Standards)

impact various aspects of medical/infectious

waste, including management of sharps, requirements for

containers that hold or store medical/infectious waste,

labeling of medical/infectious waste bags/containers, and

employee training. These requirements can be found

in the HERC section entitled OSHA

Standards for Regulated Waste.

Statutes, Regulations and Guidelines

Special Medical Wastes

Standards Applicable to Generators of Special Medical Waste

Standards Applicable to Transporters of Special Medical Waste

Communicable Disease Prevention – Handling, Treatment, and

Disposal of Special Medical Waste

Contacts

Maryland Department of the Environment, Waste Management Administration

Maryland Department of Health and Mental

Hygiene

More Information

Guidelines for Transportation of Special Medical Wastes

Application for Certification as a Special Medical Waste Hauler

Application for Special Medical Waste Vehicle Certification

Application for Special Medical Waste Haulers Certificate

Bond

Notification of Special Medical Waste Activity