Regulated Medical Waste

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 wastes" includes all of the following substances or categories of

substances:

Cultures and stocks of infectious agents and associated biologicals.
Laboratory wastes that were, or are likely to have been, in contact with infectious agents.
Pathological wastes, including human and animal tissues, organs, and body parts, and body fluids and excreta that are contaminated with or are likely to be contaminated with infectious agents.
Waste materials from the rooms of humans, or the enclosures of animals, that have been isolated because of diagnosed communicable disease that are likely to transmit infectious agents.
Human and animal blood specimens and blood products that are being disposed of.
Contaminated carcasses, body parts, and bedding of animals that were intentionally exposed to infectious agents.
Sharp wastes used in the treatment, diagnosis, or inoculation of human beings or animals
Any other waste materials generated in the diagnosis, treatment, or immunization of human beings or animals, in research or in the production of testing of biologicals.
Any other waste materials the generator designates as infectious waste.

Regulation of Infectious Wastes

The Ohio EPA’s Infectious Waste Program regulates the generation, treatment, packaging, storage, transportation, and disposal of infectious waste in the state. The detailed requirements can be found in Ohio Revised Code Chapter (ORC) 3734. Ohio Administrative Code Chapters (OAC) 3745-27 and 3745-37. Depending upon the amount of infectious waste generated in a calendar month a person is considered to be a small generator (less than 50 lbs per month) or a large generator (50 lbs or more a calendar month). A large generator must submit a registration application to the Ohio EPA.

Managing Regulated Medical Waste

Healthcare facilities are divided into two categories, depending on the quantity of infectious waste that they generate:

small quantity generators (less than 50 pounds per month of infectious waste), and
large quantity generators (50 or more pounds of infectious waste in any one month).

When calculating the quantity of infectious waste generated, do not consider the weight of blood, blood products, other body fluids, or embalming fluids that are legally discharged to a sewer system.

Rules for these two categories are provided below.

Large Quantity Generators

Generator Registration. A healthcare facility or other generator of infectious waste who generates 50 pounds or more of infectious waste during any one month must register with the Ohio EPA. Once a facility is registered, they are given a registration certificate and they must follow certain rules covering management and disposal of infectious waste.

For details concerning the registration process, see Requirements for Infectious Waste Registration Certificate, below.

Procedures. Large quantity generators must implement the following procedures:

Place all "sharps" in a suitable container (rigid, puncture-resistant, leak resistant, and closed tightly to prevent loss of contents).
Either treat all specimen cultures and cultures of viable infectious agents on the premises where they are generated to render them noninfectious or ensure that the wastes are treated to render them noninfectious at a treatment facility.
Quantify the waste generation rate and keep records recorded in pounds on a calendar month basis. This rule can be met by keeping a monthly generation rate log, keeping treatment shipping papers that document the weight of all the infectious waste that is generated and sent for treatment documented in pounds for a calendar month; or a combination of a monthly generation rate log and treatment shipping papers.
Not grind any sharp infectious wastes, not compact any such wastes until after the wastes have been treated.
Dispose of the infectious wastes at a solid waste disposal facility holding an appropriate license.
Employ only transporters who are registered to transport untreated infectious wastes.
Provide information to transporters and treatment facilities regarding the generator's system for distinguishing between waste packages that contain treated and untreated wastes.
Ensure that all infectious wastes, whether treated or untreated, that are transported offsite are accompanied by a shipping paper (see Infectious Waste Shipping Paper System, below).
Develop a spill containment and clean-up procedure.
Ensure that clean-up materials / kits are available in those areas designated in the spill containment and clean-up procedures and that they are effectively utilized, as needed.
Generators of infectious wastes may discharge untreated liquid or semi-liquid infectious wastes consisting of blood, blood products, body fluids, and excreta into a sewer system provided it is not otherwise regulated by the local authority.
A generator of infectious wastes may transport off-site infectious wastes that have been treated to render them noninfectious in the same manner as noninfectious wastes are transported.
A hospital may accept for treatment or storage prior to transportation to a treatment facility the following wastes:

Properly packaged sharp infectious wastes and all unused discarded hypodermic needles, syringes, and scalpel blades that are generated by a small quantity generator.
Infectious wastes generated by an individual for purposes of his/her own care or treatment.
Infectious wastes generated in providing care to a patient by an emergency medical services organization.

Small Quantity Generators

Although small quantity generators are exempt from some of the regulations that pertain to large quantity generators, such as use of the shipping paper system, they still must meet certain basic rules:

Identify and separate infectious from non-infectious waste at the point of generation for the purposes of determining the generator status (small vs. large) the facility.
Quantify the waste generation rate and keep records recorded in pounds on a calendar month basis. This rule can be met by keeping a monthly generation rate log, keeping treatment shipping papers that document the weight of all the infectious waste that is generated and sent for treatment documented in pounds for a calendar month; or a combination of a monthly generation rate log and treatment shipping papers.
Determine by monthly records if fifty pounds or more of infectious waste is generated. If the monthly quantity reaches 50 pounds in any month, the facility must register and obtain a certificate.
Place all "sharps" in a suitable container (rigid, puncture-resistant, leak resistant, and closed tightly to prevent loss of contents).
Either treat all specimen cultures and cultures of viable infectious agents on the premises where they are generated to render them noninfectious or ensure that the wastes are treated to render them noninfectious at a treatment facility.
A small quantity generator who complies with the above sharps rules may transport and dispose of infectious wastes in the same manner as solid wastes.

Packaging and Labeling Infections Waste

The following rules apply to packaging of infectious waste.

Bags must be red in color or conspicuously labeled with the international biohazard symbol.

Each bag must be constructed of material of sufficient single thickness to preclude ripping, tearing, or bursting under normal conditions.
Bags must be of sufficient film strength, strength of seals, and leakage resistance.
Bags must be impervious to moisture;
Filled bags must be securely tied or sealed to prevent leakage or expulsion of wastes from them during storage, handling, or transport.
Bags containing infectious wastes that are being transported off-site must be placed inside a second sealed plastic bag or one single bag within a fully enclosed, rigid, sturdy container.
Containers for infectious waste must be at a minimum labeled with the international biohazard symbol on two opposite sides.
Reusable containers must be thoroughly cleaned with a detergent and disinfected after each use.
Sharps containers must be rigid, puncture-resistant, leak resistant, and closed tightly to prevent loss of contents. Sharps containers must be only those containers specifically designed and manufactured for the management and/or disposal of sharps.

Storage Requirements

The following rules apply to the storage of infectious waste:

Infectious waste must be stored in a manner which maintains the integrity of the packaging.
Infectious waste must be kept in a nonputrescent state.
Clearly mark all storage areas.
Infectious waste must be stored in a manner such that the IW does not become a food source or breeding place for insects or animals.
Outside storage areas must be locked.
May not store IW for more than 35 days.
“In-use” sharps containers are not considered storage.

On-Site Treatment of Infectious Waste

Large generators that treat infectious waste on-site must abide with certain rules. Treatment methods approved in the state of Ohio include:

Incineration,
Autoclaving,
Chemical treatment, and
Encapsulation.

Alternative treatment technologies must be approved by the Ohio EPA.

For details on infectious waste treatment, see Standards for Treatment of Infectious Wastes, below.

OSHA Regulations

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. Ohio 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.

Statutes, Regulations and Guidelines

OAC Chapter 3745-27: Solid & Infectious Waste Regulations

Standards for Generators of Infectious Waste

Requirements for Infectious Waste Registration Certificate

Infectious Waste Shipping Paper System

Standards for Packaging Infections Wastes

Standards for Treatment of Infectious Wastes

Contacts

The Division of Solid & Infectious Waste Management (DSIWM) Central Office is comprised of several technical units. These units provide technical expertise regarding various different regulatory programs to DSIWM District Office field staff, the regulated community, and the general public. Contact the Division of Solid and Infectious Waste Management

An infectious waste specialist in the Ohio EPA central office who can be reached by telephone at 614-644-2621 or write to: Ohio EPA - DSIWM; Infectious Waste Specialist; P.O. Box 1049; Columbus, OH 43216-1049.

More Information

Ohio EPA Infectious Waste Guidance