Regulated Medical Waste

Minnesota

Infectious Waste

Background Information
Definition of Infectious Waste
Managing Infectious Waste
OSHA Regulations
Statutes, Regulations and Guidelines
Contacts
More Information

Background Information

Medical waste differs from hazardous waste. Hazardous waste is regulated by the US EPA (and related state rules) under the Resource Conservation and Recovery Act. Medical waste is not covered federal environmental laws or US EPA regulations (with the exception of a medical waste that also meets the definition of hazardous waste). Rather, medical waste is mostly controlled by state law and associated regulations. In addition to state environmental agency laws/rules, aspects of medical waste management are also controlled by the Occupational Safety & Health Administration (federal and/or state) and Department of Transportation (federal and state).

Each of our 50 states have developed rules and implemented regulations for medical waste. The state rules vary to some extent, including terminology. Depending on which state you live in, you may hear the terms regulated medical waste, biohazardous waste or infectious medical waste. In most cases, these terms all refer to the same thing: that portion of the medical waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.

Most states have regulations covering packaging, storage, and transportation of medical waste. Some states require health care facilities to register and/or obtain a permit. State rules may also cover the development of contingency plans, on-site treatment, training, waste tracking, recordkeeping, and reporting.

In most states, the environmental protection agency is primarily responsible for developing and enforcing regulations for medical waste management and disposal. Although in some states, the department of health may play an important role or even serve as the primary regulatory agency. Where both agencies are involved, typically the department of health is responsible for on-site management and the environmental agency is responsible for transportation and disposal.

OSHA, whether it is the U.S. Department of Labor Occupational Safety & Health Administration or an OSHA state program (24 states operate their own program), regulates several aspects of medical waste, including management of sharps, requirements for containers that hold or store medical waste, labeling of medical waste bags/containers, and employee training. These standards are designed to protect healthcare workers from the risk of exposure to bloodborne pathogens. However, they also help to systematically manage wastes, which benefit the public and environment.

Regulated medical waste is defined by the US Department of Transportation as a hazardous material. DOT rules mostly apply to transporters rather than healthcare facilities; although, knowledge of these rules is important because of the liability associated with shipping waste off-site.

Waste Categories

Hazardous wastes are wastes that have been classified as hazardous by the federal Environmental Protection Agency (EPA) or the Minnesota Pollution Control Agency (MPCA). A waste is hazardous if it appears on one of four lists of known hazardous wastes (F, P, K or U lists), if it displays a hazardous characteristic or if it contains 50 parts per million or more polychlorobiphenyls (PCBs). A ‘characteristic’ hazardous waste is one that meets the definition in the Minnesota Rules for ignitability, oxidizer, corrosivity, reactivity, lethality or toxicity.
Industrial solid waste is all solid waste generated from an industrial or manufacturing process, nonmanufacturing activities such as service and commercial establishments, construction debris and asbestos. Health care wastes that are not liquids, not gases, not hazardous, not infectious, not pharmaceuticals or radioactive, and not office materials or food preparation waste are industrial solid waste.
Infectious waste is waste that has the potential to transmit disease - regulated body fluids (blood and blood products and amniotic, cerebrospinal, pericardial, peritoneal, pleural and synovial fluids) and items dripping with those fluids, laboratory waste (waste cultures and stocks), infected research animal waste, sharps and pathology waste. Infectious waste is also sometimes called biohazardous, red bag or regulated medical waste. Infectious waste is not the same as hazardous waste.
Pharmaceutical waste includes expired drugs, medications left behind when a patient expires or leaves a health care facility, waste materials containing chemotherapy drug residues (syringes, IV bags, tubing, etc.) and drugs that are intended to be discarded.
Radioactive wastes contain radioactive materials. Radioactive materials are used in, and wastes generated by, several areas of a health care facility including nuclear medicine, nuclear cardiology, radiation oncology, blood bank, clinical laboratories, and research laboratories. Although X-rays are a form of radiation, they do not “contaminate” items and therefore, are not a source of radioactive wastes.
Sewerable waste is liquid waste that is usually regulated by the generator’s wastewater treatment plant authority or, in some cases, the MPCA. Most of the metropolitan areas and many of the larger cities within Minnesota have local rules regulating the discharge of wastewater into the sanitary sewer. While rules may vary for different cities, limits are usually set for metals and pH. Some wastes may be prohibited, such as flammables, oils, solids, corrosives, hazardous, ground up solids and infectious wastes. Wastewaters, such as non-contact cooling and storm water, may also be prohibited from the sanitary sewer. If part of an approved infectious waste management plan, blood and body fluids may be allowed to be discharged to the sanitary sewer. Check with your wastewater treatment plant authority. Certain wastes may be discharged after they have been treated, such as acids or caustics after adjusting the pH or x-ray fixer after treating to remove silver.

Definition of Infectious Waste

Infectious waste means waste originating from the diagnosis, care, or treatment of a person or animal that has been or may have been exposed to a contagious or infectious disease. Unless the materials have been rendered noninfectious by procedures approved by the state commissioner of health, infectious waste includes:

All wastes originating from persons or animals placed in isolation for control and treatment of an infectious disease;
Bandages, dressings, casts, catheters, tubing, and similar disposable items which have been in contact with wounds, burns, anatomical tracts, or surgical incisions and which are suspect of being or have been medically verified as infectious;
All infectious anatomical waste, including human and animal parts or tissues;
Infectious sharps and needles;
Laboratory and pathology waste of an infectious nature; or
Any other waste, as defined by the state commissioner of health, which, because of its infectious nature, requires handling and disposal in a manner prescribed for other types of infectious waste.

Managing Infectious Waste

Infectious waste is not the same as hazardous waste, although some wastes can be both hazardous and infectious. Manage wastes that are both hazardous and infectious as hazardous waste.

Infectious waste, also called biohazardous or red bag waste, cannot be placed in the normal trash for disposal at a landfill or industrial burner. Infectious waste must be segregated and go through a decontamination process before it is considered safe for routine handling as a solid waste.

For this reason, infectious waste is routinely collected in special containers - sharps containers and red bags. After decontamination, the waste can be handled by haulers, storage, treatment and disposal facilities that have submitted solid waste management plans to the MPCA according to Minnesota Solid Waste Rules. The management plans address packaging and labeling, handling and segregation, storage, transportation, spill response, treatment and disposal.

Infectious waste requirements apply to both Facility Owners and Operators, and Commercial Transporters.

Packaging and Labeling Requirements.

No commercial transporter shall receive any infectious waste and no facility owner or operator shall receive for offsite decontamination, storage, or disposal, any infectious waste that is not packaged in accordance with the following requirements:

Sharps must be in rigid, puncture-resistant containers that have lids or caps that are designed to preclude loss or leakage of the contents.
Sharps must remain packaged throughout collection, storage, decontamination, and any handling processes that precede disposal, unless the sharps have been treated by a process that renders them incapable of inducing subdermal inoculation. This item does not prevent the use of sharps containers that are designed to be reusable if applicable parts of the regulations with.
Sharps containers, or infectious waste containers that include sharps containers, that will be transported to an offsite facility must be labeled, on the outer container, with "Sharps" in letters at least one inch high with a stroke width of one-eighth inch and with either the international biohazard symbol, at least three inches by three inches, or the words "Infectious Waste" in letters at least one inch in height with a stroke width of one-eighth inch.
Infectious waste, except for sharps, must be contained in plastic bags that are impervious to moisture, and of sufficient strength to preclude ripping, tearing, or bursting under normal conditions of use and handling. Each plastic bag must be constructed of material of sufficient single thickness and strength to pass the 165-gram dropped dart impact resistance test as prescribed by ASTM Standard D 1709-75, which is incorporated by reference, and is not subject to frequent change. The bags must be secured to prevent leakage of waste during handling, decontamination, storage, transport, or disposal.
Plastic bags of infectious waste that will be shipped offsite must be packaged for storage or handling by placement in corrugated fiberboard boxes or equivalent rigid containers such as reusable pails, cartons, or portable bins. Containers must have tight-fitting covers and be securely sealed.
Boxes and rigid containers of infectious waste must be conspicuously labeled with the words "Infectious Waste" in letters at least one inch high, with a stroke width of one-eighth inch, or the international biohazard symbol, at least three inches by three inches.
Containers that have been in direct contact with infectious waste must be disinfected as required in the regulations, before further use.

Storage Requirements

Offsite facility owners and operators must store waste in accordance with the following requirements:

Infectious or pathological waste must be segregated from other wastes in a storage area designed to prevent the entry of vermin. Storage areas for infectious or pathological waste must be secured to deny access by unauthorized persons and must be prominently marked with the international biohazard symbol and with the words "Infectious Waste" on or adjacent to the exterior of entry doors and access gates.
Interior surfaces of storage areas must be constructed of materials that are easily cleaned.
Offsite storage areas must be designed to contain spills.
Infectious or pathological waste must not be allowed to become putrescent during storage or at any time.
Storage facility owners and operators must comply with the spill response requirements in the regulations.

Decontamination Requirements

Facility owners and operators may use incineration, autoclaving, or other decontamination methods that have been approved by the commissioner for the decontamination of infectious waste. Facility owners and operators shall use handling and storage practices and decontamination methods that comply with the regulations.

Generator Transport Requirements

Generators who transport their own infectious waste to an offsite decontamination, storage, or disposal facility must comply with required packaging, labeling, and storage requirements.
Generators who provide not-for-compensation or at cost infectious waste collection and transport services for other generators or groups of generators that provide not-for-compensation infectious waste collection and transport service for the group must comply with the packaging, labeling, and storage requirements.
Generator transport vehicles that exceed 7,000 pounds gross vehicle weight must be identified on each side of the vehicle, and on the access doors to any area holding infectious waste, with the name of the transporter and the words "Infectious Waste" in letters six inches high with a stroke width of three-fourths inch or with the international biohazard symbol, eight inches by eight inches. Magnetic placards that meet these specifications are acceptable.
Generators who transport infectious waste in vehicles that exceed 7,000 pounds gross vehicle weight must comply with applicable regulations, in addition to providing the name and title of the individual responsible for the implementation of infectious waste activities

Commercial Transporter Requirements

A commercial transporter must possess a valid transporter registration.
The required commercial transporter's management plan must be kept at the address identified as the commercial transporter's principal place of business.
A commercial transporter who transports infectious waste offsite and facilities that receive the waste must be in compliance with the regulations.
A commercial transporter must not accept infectious waste from a generator who does not have a management plan acknowledgment card issued by the Minnesota Department of Health or a storage facility or treatment facility that does not have a required management plan.
Infectious waste must be transported in a fully enclosed vehicle compartment.
Infectious waste must be delivered for decontamination, storage, or disposal only to a facility owner or operator that has an approved management plan onsite or to a facility owner or operator that is exempt from the requirements for a management plan.
A commercial transporter must not deliver infectious waste to a facility owner or operator prohibited from accepting the waste.
Surface areas of equipment used to transport infectious waste must be smooth and easily cleaned.
Infectious waste must not be compacted during transport. Sharps containers, or infectious waste containers that include sharps containers, must never be compacted, whether or not the sharps have been decontaminated. Containers must be secured to prevent movement during transport.
Infectious waste must not be allowed to become putrescent during transportation.
A person must not transport or receive for transport infectious waste that is not properly packaged and labeled.
Commercial transporters must comply with all applicable regulations.
Commercial transporter vehicles must bear labels or placards that comply with the regulations.
Vehicles transporting infectious waste must be identified on each side of the vehicle, and on the access doors to any area holding infectious waste, with the name of the transporter and the words "Infectious Waste" in letters six inches high with a stroke width of three-fourths inch or with the international biohazard symbol, eight inches by eight inches.
The vehicle identification number that is issued by the commissioner must be displayed on the single unit vehicle or trailer to which it is assigned in letters and numbers at least four inches in height with a stroke width of one-half inch.

Spill Response Plan

A spill cleanup kit must be available for use in areas used for the storage, decontamination, or disposal of infectious waste and also on each transport vehicle. The cleanup kit must include at least:

Absorbent material for spilled liquids;
One gallon of hospital grade disinfectant or disinfectant made of a formula listed in the regulations;
Packaging and labeling, as required by the regulations.
Scoop shovel, push brooms, and plastic buckets; and
Disposable coveralls, latex and neoprene gloves, surgical type face mask, and goggles.

Response to a spill must include the following minimum procedures:

Access to the spill area by unauthorized personnel must be prevented;
Broken containers and spillage must be packaged and labeled as required by the regulations;
Absorbent material must be applied to surface areas that have been contaminated with infectious waste; and
Reusable items must be cleaned and disinfected using the required procedures.

Procedures for disinfecting contaminated surfaces include, but are not limited to, agitation to remove visible soil and application of one of the following chemical sanitizers for the contact time required by the manufacturer's label:

Hypochlorite solution (500 ppm available chlorine);
Phenolic solution (500 ppm active ingredient);
Iodoform solution (100 ppm active ingredient); or
Other chemical sanitizer solutions of equivalent disinfectant strength.

Financial Assurance

As a condition of management plan approval, an offsite storage facility owner or operator shall provide to the agency evidence of financial assurance annually to the commissioner on the anniversary date of management plan approval:

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. Minnesota is one of 21 states operating an approved occupational safety and health program. This program is operated by the Minnesota OSHA.. 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.