Regulated Medical Waste

Pennsylvania

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.

Definition of Infectious Waste

Infectious waste is municipal and residual waste which is generated in the diagnosis, treatment, immunization or autopsy of human beings or animals, in research pertaining thereto, in the preparation of human or animal remains for interment or cremation, or in the production or testing of biologicals, and which falls under one or more of the following categories:

Cultures and stocks of infectious agents and associated biologicals, including the following: cultures from medical and pathological laboratories; cultures and stocks of infectious agents from research and industrial laboratories; wastes from the production of biologicals; discarded live and attenuated vaccines except for residue in emptied containers; and culture dishes, assemblies and devices used to conduct diagnostic tests or to transfer, inoculate and mix cultures.
Pathological wastes. Human pathological wastes, including tissues, organs and body parts and body fluids that are removed during surgery, autopsy, other medical procedures or laboratory procedures. The term does not include hair, nails or extracted teeth.
Human blood and body fluid waste.
- Liquid waste human blood.
- Blood products.
- Items saturated or dripping with human blood.
- Items that were saturated or dripping with human blood that are now caked with dried human blood, including serum, plasma and other blood components, which were used or intended for use in patient care, specimen testing or the development of pharmaceuticals.
- Intravenous bags that have been used for blood transfusions.
- Items, including dialysate, that have been in contact with the blood of patients undergoing hemodialysis at hospitals or independent treatment centers.
- Items saturated or dripping with body fluids or caked with dried body fluids from persons during surgery, autopsy, other medical procedures or laboratory procedures.
- Specimens of blood products or body fluids, and their containers.
Animal wastes. Contaminated animal carcasses, body parts, blood, blood products, secretions, excretions and bedding of animals that were known to have been exposed to zoonotic infectious agents or nonzoonotic human pathogens during research (including research in veterinary schools and hospitals), production of biologicals or testing of pharmaceuticals.
Isolation wastes. Biological wastes and waste contaminated with blood, excretion, exudates or secretions from:
- Humans who are isolated to protect others from highly virulent diseases.
- Isolated animals known or suspected to be infected with highly virulent diseases.
Used sharps. Sharps that have been in contact with infectious agents or that have been used in animal or human patient care or treatment, at medical, research or industrial laboratories.

Exceptions to the definition of infectious waste includes:

Wastes generated as a result of home self-care.
Human corpses, remains and anatomical parts that are intended for interment or cremation, or are donated and used for scientific or medical education, research or treatment.
Etiologic agents being transported for purposes other than waste processing or disposal pursuant to the requirements of the United States Department of Transportation, the Pa. Department of Transportation and other applicable shipping requirements.
Samples of infectious waste transported offsite by Commonwealth or United States government enforcement personnel during an enforcement proceeding.
Body fluids or biologicals which are being transported to or stored at a laboratory prior to laboratory testing.
Ash residue from the incineration of materials if the incineration was conducted in accordance with infectious waste monitoring requirements. The ash residue shall be managed as special handling municipal waste.
Reusable or recyclable containers or other nondisposable materials, if they are cleaned and disinfected, or if there has been no direct contact between the surface of the container and materials. Laundry or medical equipment shall be cleaned and disinfected in accordance with the U.S. Occupational Safety and Health Administration Requirements relating to bloodborne pathogens.
Soiled diapers.
Mixtures of hazardous waste and other materials identified in the regulations shall be managed as hazardous waste and not infectious waste.
Mixtures of materials identified in the regulations and regulated radioactive waste shall be managed as radioactive waste in accordance with applicable Commonwealth and Federal statutes and regulations.
Mixtures of materials identified in the regulations and chemotherapeutic waste shall be managed as chemotherapeutic waste.

Managing Infectious Waste

The Pennsylvania Department of Environmental Protection (DEP) has comprehensive rules for the management of infectious waste. The rules include requirements for storage, transport, disposal, licensing and processing.

Basic Storage Requirements

Infectious and chemotherapeutic waste shall be stored and contained in a manner that:

Maintains the integrity of the containers, prevents the leakage or release of waste from the containers and provides protection from water, rain and wind;
Prevents the spread of infectious or chemotherapeutic agents;
Affords protection from animals and does not provide a breeding place or a food source for insects or rodents;
Maintains the waste in a nonputrescent state;
Prevents odors from emanating from the container; and
Prevents unauthorized access to the waste. As part of this requirement, the following shall be met:

Enclosures and containers used for storage of infectious or chemotherapeutic waste shall be secured to deny access to unauthorized persons. Enclosures and containers shall also be marked with prominent warning signs indicating the storage of infectious or chemotherapeutic waste.

Enclosures at a waste generating or processing facility that are used for the storage of infectious or chemotherapeutic waste shall be constructed of finish materials that are impermeable and capable of being readily maintained in a sanitary condition. Storage areas shall be ventilated to minimize human exposure to the exhaust air.

Infectious and chemotherapeutic waste may not be commingled with other waste.

The generator may store infectious and municipal waste that has been sorted and separately containerized on the same cart for movement to an onsite processing or disposal facility. Chemotherapeutic waste may also be stored on the cart with municipal and infectious waste if it is sorted and

Sorting

Infectious and chemotherapeutic waste shall be placed in separate containers from other waste at the point of origin in the generating facility. Infectious and chemotherapeutic waste may be stored together in the same container if approved in writing by the Department.

Used sharps, regardless of whether they are infectious or chemotherapeutic waste, may be stored in the same container

Infectious waste shall be sorted at the point of origin in the generating facility into the following three classes, and each class shall be placed in a separate container:

Used sharps;
Fluid quantities greater than 20 cubic centimeters; and
Other infectious waste.

Chemotherapeutic waste shall also be sorted at the point of origin in the generating facility into the same classes. However, fluids must be separated regardless of the volume.

Sorted and separately containerized infectious waste may be placed together into another container for onsite handling or offsite transportation.

Storage for Infectious Waste for Generators

Generators of infectious or chemotherapeutic waste may store the waste onsite according to the following requirements:

Infectious waste, excluding used sharps, may be stored at room temperature until the storage container is full, but for no longer than 30 days from the date waste was first placed in the container. If the infectious waste becomes putrescent during the storage period, the waste shall be moved offsite within 24 hours for processing or disposal.
A storage container filled with infectious waste may be stored in a refrigeration unit for up to 30 days from the date waste was first placed in the container.
A storage container of infectious waste that has been filled within 30 days from the date waste was first placed in the container may be frozen immediately for up to 90 days from the date waste was first placed in the container.

Used sharps containers may be used until full as long as the storage is in accordance with basic storage requirements.

Storage for Infectious Waste Processors

If the waste processing facility is separate from the waste generating facility, infectious waste may not be stored at the waste processing facility for more than the following periods unless other periods are approved in a permit:

Seventy-two hours at a temperature ‹=28°C;
Seven days in a refrigerator at ‹=7°C; or
Thirty days in a freezer at ‹=-18°C.

Storage Containers

Infectious and chemotherapeutic waste shall be placed in containers that are leak proof; impervious to moisture; and sufficient in strength to prevent puncturing, tearing or bursting during storage.

In addition to the above requirements, used sharps shall be stored in containers that are rigid; tightly lidded; and puncture resistant.
In addition, infectious waste fluids in quantities greater than 20 cubic centimeters, and chemotherapeutic waste fluids shall be stored in containers that are break-resistant; and tightly lidded or tightly stoppered.

When bags are used as the only storage container, double or multiple bagging shall be used and the following requirements shall be met:

Upon packaging, bags shall be securely tied.

The bag shall be constructed of material of sufficient single thickness strength to meet DEP requirements and ASTM Standards. The bags shall be certified.

Marking of Containers

The outermost container for each package of infectious or chemotherapeutic waste for offsite transportation shall be labeled immediately after packing. The label shall be securely attached and be clearly legible. Indelible ink shall be used to complete the information on the label. If handwritten, the label shall be at least 3 inches by 5 inches in dimension. The following information shall be included on the label:

Name, address and telephone number of the generator;
Date the waste was generated; and
The name of the transporter and, if applicable, Department-issued infectious and chemotherapeutic waste transporter license number.

The following information shall be printed on the outermost container or bag for each package of infectious or chemotherapeutic waste for either onsite movement or offsite transportation:

The words “infectious waste’’ or “chemotherapeutic waste,’’ whichever is applicable; and
The universal biohazard symbol.

A container used for infectious waste cannot be used again unless it has been decontaminated, or the container surface has been protection from direct contact with the waste.

Transportation

Only DEP-licensed transporters may transport infectious and chemotherapeutic waste. Transporters must follow strict requirements in regard to containment and packaging, in order to maintain the integrity of the containers and to prevent leakages, spills and releases of the waste. Transporters must also comply with annual reporting requirements.

Permit-by Rule—On-Site Processing Facilities

A majority of infectious and chemotherapeutic waste on-site processing facilities may receive a permit-by-rule, if they meet the following conditions:

The facility complies with all applicable municipal waste storage, collection and transportation requirements;
The facility has all required and necessary permits;
The facility operator maintains all required plans, records, disposal and other DEP-required information in a readily accessible location;
Waste processing does not adversely affect the public health, safety, welfare or the environment;
Waste is properly disinfected; and
A log with required information is kept for each disinfection unit.

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. Pennsylvania is one of 26 states covered entirely by the federal OSHA program. This program is operated by the Occupational Safety and Health Administration. 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.