If you're in any field that generates medical waste, you must be aware of all federal medical regulations as they pertain to that waste. It's not as straightforward as simply familiarizing yourself with overarching federal medical waste regulations. A number of federal agencies are involved with creating and assuring that rules are being followed. States also have their own rules for medical waste management. Both must be followed. If not, you and your medical facility, regardless of size, may face staggering fines for non-compliance.

As a medical waste generator, know where the find the rules.

01   /  Who makes Federal Waste Regulations?

A number of federal agencies are involved in making and enforcing medical waste regulations. Among them include:


Environmental Protection Agency (EPA) – be aware that in addition to federal guidelines, every state also has their own EPA or Department of Natural Resources (DNR) that make rules applicable to medical waste management.


Resource Conservation and Recovery Act (RCRA) – while not an agency, the RCRA provides regulatory guidelines of the EPA when it comes to hazardous medical waste.


Occupational Safety and Health Administration (OSHA) – created to ensure the safety of employees in their workplace.


Drug Enforcement Agency (DEA) – especially important for medical providers dispensing or using pharmaceutical medications or drugs.


Department of Transportation (DOT) – also obey your state’s DOT guidelines.

An overview of the EPA’s regulations regarding medical waste can be found here. Guidance for pharmaceutical waste management can be found on the EPA website as well, along with numerous rules for hazardous medical waste generators.

Review of Title 40 of the Code of Federal Regulations (CFR 40) – Protection of the Environment is a good place to start. Title 49 CFR focuses on medical waste regulations, collection, and disposal processes. For example, Part 173.197 focuses on regulated medical waste.

02   /   About OSHA

While every state also has specific regulations relating to proper medical waste disposal, businesses within individual states must still comply with federal OSHA regulations. Because OSHA is a federal regulatory body, all states fall under this umbrella and are subject to their rules.

Every OSHA regulation relating to medical waste is designed to ensure the safety of anyone who comes in contact with that waste. The agency has established specific criteria and guidelines that dictate the safe handling, transport, and disposal of medical waste.

While OSHA does not regulate final disposal processes of medical waste, they do set requirements, such as those involving blood-borne pathogens according to the guidelines of 29 CFR 1910.1030 and other potentially infected materials or OPIM.

03   /   More on Regulated Medical Waste

Also known as red bag waste or biohazardous waste, or infectious waste, regulated medical waste is often created in doctors' offices, hospitals, and anywhere where there are items that need to be disposed of that came in contact with blood, bodily fluids, or OPIM.

Anything that has come in contact with blood must be properly disposed of in a red bag or approved biohazardous container. Red bags, however, are not for all medical waste. For example, putting expired medication in red bag waste is against OSHA protocols. (Pharmaceutical waste streams require their own disposal processes.)

Sharps waste is also regulated. Remember that proper sharps disposal entails putting any used sharp (needles or anything that has the potential to poke, slash, cut, or stab the skin) in a puncture-resistant sharps container. Compliant sharps containers are red or reddish-orange in color, are leak-proof and resist dripping or crushing. All sharps must be placed in an appropriately labeled (BIOHAZARD marked) sharps container before they are placed in the red bag.

Carefully review OSHA laws for regulated medical waste management and be aware of ALL federal guidelines regarding its disposal.

04   /   OSHA Compliance & Fines

While the majority of medical care providers and their employees are aware of OSHA regulations regarding regulated medical waste, it pays to maintain training protocols. While medical care facilities are required to maintain compliance, there are some that take shortcuts or try to bend the rules.

Be aware that OSHA fines can be steep. A serious OSHA violation can cost up to $13,653 for a single violation that has not been addressed in a timely manner. Less serious violations incur fines of approximately $5,851 while moderate violations range from $7,802 and up to $11,703 – per violation.

Consequences and penalties can escalate if a doctor's office or hospital is found to be willfully negligent over multiple instances.

05   /   Regulated Medical Waste Disposal

To properly dispose of medical waste, it must go into a medical waste autoclave before disposal to a landfill. This autoclaving machine runs at about 300 degrees for specified time frames in order to destroy all bacteria and germs found in the red bag waste. The only exceptions to this are trace chemotherapy and pathological waste. Though still considered regulated medical waste, pathological and chemotherapy waste must go through non-hazardous incineration instead.

Note that state laws differ when it comes to autoclave and incineration rules. While most states require incineration of certain medical waste streams, not all do. Also, some states require a certificate of destruction. This way, if audited by a state agency or put through an OSHA audit, documentation exists that the waste was properly disposed of.

06   /   Cover your Bases with a Full-Service Medical Waste Management Company

Because the consequences of non-compliance of proper regulated medical waste disposal are potentially high, it's best to seek a full-service medical waste management company such as MCF Environmental Services, who can guide you through the process of how to properly handle your generated medical waste. When selecting a medical waste management company, keep the following issues in mind:


All medical waste management companies must be properly insured and permitted to handle your generated waste.


All drivers should be properly trained.


The company should always provide you with the proper paperwork. This includes the bill of lading, which needs to accompany any regulated medical waste shipment.


You want to work with a company that's thoroughly versed in both state and federal regulations. Because laws vary from state to state, work with an experienced and knowledgeable company that keeps up-to-date with the latest industry-specific changes, updated federal and state regulations, updates, and news.

For more information about federal or state laws and how they impact medical waste, contact a representative of MCF Environmental Services. With over three decades of experience, we specialize in regulated and hazardous waste management and disposal. Based in Atlanta, Georgia, we offer our services in states throughout the country.

Robert Losurdo

President, COO