Written by David Skinner
19 Jul 2018

Navigating Medical Waste Regulations and Industry Oversight

When it comes to medical waste disposal, compliance with federal and state guidelines is essential. But first, it's vital to know who regulates the medical waste disposal industry.

Compliance can get a bit confusing for healthcare facilities – large and small – because regulations differ between different types of medical waste and their required disposal and treatment methods. Let us help... 

Depending on service volume and size of facility, healthcare organizations may generate the following waste streams:

  • Microbiological waste
  • Sharps waste
  • Biohazard waste
  • Infectious waste
  • Pathological waste
  • Pharmaceutical waste
  • Chemotherapy waste (or other chemical waste including laboratory reagents, disinfectants, film developers)


Waste segregation is the first step in maintaining compliance with hazardous waste disposal (even though not all medical waste is deemed hazardous). State and federal guidelines for medical waste management clearly define how each category of waste should be collected and disposed of; for example there is a big difference in how sharps can be disposed of and how chemotherapy waste should be disposed of. Daniels Health understands the importance of clarity, especially when it comes to federal and state guidelines for the storage, transport, and the disposal of non-hazardous and hazardous medical waste.


Medical Waste Regulation: Disposal, Storage and Transport

According to the Environmental Protection Agency, regulations for the storage, transport, and disposal of medical waste depend on the type of medical waste under consideration. Acceptable methods for disposing of a syringe with a needle are different to those concerning the disposal of an animal carcass or human tissues.

This is why specificity is key. For example, when it comes to disposal of sharps, they are to be placed into a container that is:

  • Shatterproof, durable (due to heavy handling), leak-proof, and puncture resistant
  • Marked with a universal biohazard label
  • Designed so that during handling, contents won't fall out
  • Equipped with a safe yet accessible opening that enables users to easily determine when the container is full

Pharmaceutical Waste Disposal Guidelines

Guidelines for pharmaceutical waste disposal are more complicated, specifically dependent upon the definition of various hazardous waste categories. The EPA classifies pharmaceutical waste by four categories:

  • Regulated hazardous pharmaceutical waste
  • Non-regulated hazardous pharmaceutical waste
  • Non-regulated "non-hazardous" pharmaceutical waste
  • Minimization of pharmaceutical waste 

* Other considerations must be factored into these categories such as dosages and form of the pharmaceutical waste (tablet, capsule, injectable).


Who Regulates the Medical Waste Disposal Industry? 

Healthcare facilities are responsible for checking with state regulators as well as federal agencies regarding interpretation of regulations. To remain compliant, healthcare facilities should regularly refer to the rulings and summaries for management standards of hazardous waste pharmaceuticals (42 U.S.C. § 6921-6924). State regulations may be more stringent than federal guidelines and vary from state to state, and those guidelines and regulations are routinely updated. 

But who regulates the medical waste disposal industry? There are actually several agencies involved, including: 

  • The Environmental Protection Agency (EPA)
  • Department of Transportation (DOT)
  • Drug enforcement administration (DEA)
  • Occupational Safety and Health Administration (OSHA)
  • State environmental protection agencies,
  • State pharmacy boards, and
  • Local publicly owned treatment works (PO TW)

The first step is to define and segregate medical waste for disposal. Compliant collection and transport of medical waste is also specifically mandated.


View State Regulations


Regulations for the Collection and Disposal of Medical Waste

With each type of medical waste specifically defined by federal and state guidelines, it is imperative that waste is segregated prior to disposal. Removal and transport of medical waste for disposal must be carried out by individuals or companies licensed by the EPA for the collection and transport of medical waste. An individual engaged by the healthcare facility may also transport waste directly to either a hospital with appropriate disposal methods or a waste depot licensed by the EPA.

Disposal of medical waste regulations (concerning both hazardous and non-hazardous waste) primarily fall under the Resource Conservation and Recovery Act  (RCRA) along with the Hazardous and Solid Waste Amendments (HSWA). These amendments extend RCRA regulations to include medical and biohazard waste disposal, among other types of medical waste.

The primary objective of the RCRA is to provide protection to human health and wellness and the environment from the generation, transportation, treatment, storage, and/or disposal of hazardous wastes. These objectives specify that wastes be properly treated before disposal, reducing harm to groundwater, leeching of hazardous waste and particulates into the environment, and reducing toxicity by previously removing or destroying harmful particles and/or constituents of medical waste.


When it comes to treatment standards, special regulatory requirements apply to certain types of waste with specific characteristics such as:

  • Corrosive waste
  • Reactive waste
  • Toxic waste
  • Ignitable waste

The bottom line - any hazardous waste that will ultimately end up in some form of land disposal or disbursement is required to meet all applicable treatment standards prior to such disposal processes. Standards applicable to hazardous waste can be found under Title 40 of the Code of Federal Regulations (CFR) §268.40.


Treatment Methods for Medical Waste Disposal

As guardians of our customers' waste compliance, we are committed to performing all treatment in a responsible manner in accordance with legislation, regulations, codes of practice, standards and license requirements. Where local and federal level regulations permit, Daniels opts for the most environmentally sustainable methods of waste treatment.

Thermal Autoclave Treatment

Daniels Health use thermal autoclave treatment for regulated medical waste disposal (RMW). This includes sharps, regulated medical waste and pathological waste (excluding arms, legs and torsos)… just painted a nice picture for you didn’t it! Autoclave is the most environmentally responsible process for the treatment of RMW and other infectious wastes and aligns with our mission of sustainability throughout our operations. Utilizing pressure chambers that sterilize supplies and equipment in steam "baths" of approximately 285°, the Autoclave denatures the waste by way of high pressure steam sterilization.

Autoclave chambers differ in size, with some of the largest ranging 30 feet long, 6 feet wide, and 6 feet tall. Waste remains in the autoclave for at least 20 minutes and the pressure chamber typically runs through three cycles for a total time of 60 minutes. By the end of cycle, the waste contents have been reduced (melted) and commingled with all other waste and represent a volume less than 50% of the original volume. Processed waste is then either compacted or shredded.

Alternative Non-Incineration Methods

Other “non-incinerated” medical waste disposal options are available, including:

  • Chemical - most common in the treatment and disposal of liquid wastes and chemical wastes
  • Microwave (irradiative) - microwave or irradiation methods are effective for infectious wastes and sharps wastes, but are not intended for use with pathological waste 

Incineration and Future Directions

The focus of technological advancements in the US in regard to medical waste disposal is to reduce hazards to humans and the environment. The most common method for the treatment and destruction of non-RMW medical waste is through incineration, utilized most commonly by Daniels Health for chemotherapy, pharmaceutical and other forms of hazardous waste. Incineration continues to be the most cost-effective method of medical waste disposal, with incinerators burning at temperatures ranging anywhere between 1000°F and 2000°F.  In the US, research and development continues to seek ways to reduce emissions produced via incineration. The Clean Air Act requires the EPA to review standards for medical waste incinerators every five years, with requirements for lowering emissions from air pollutants and improving segregation and medical waste management methods.


The number of medical waste incinerators in the US has declined approximately 25%, while at the same time promoting less expensive and more environmentally friendly alternatives such as autoclaving. Nevertheless, a fifteen-year plan for upgrades for hospital, medical, and infectious waste incinerators were to be met by February 2018 in regard to existing facility compliance under CAA §129. The ultimate goal of the EPA is to end all incineration methods in the US, promoting instead autoclaving/landfilling alternatives that would reduce the amount of toxic air emissions annually


Daniels Health: Your Partner in Compliance and Safety for Medical Waste Management 

Daniels Health stands at the forefront of medical waste management, offering unparalleled expertise in ensuring compliance and safety across healthcare facilities. 

With a vigilant eye on the ever-evolving landscape of federal and state regulations, Daniels Health proactively adapts its products and services to meet the highest standards of compliance. This commitment is reflected in our comprehensive solutions tailored to manage a broad spectrum of regulated medical waste. By prioritizing customer safety and strict adherence to regulatory frameworks, Daniels Health solidifies its role as a trusted partner in the healthcare industry, dedicated to safeguarding both healthcare workers and the community at large.


The Daniels Difference

With 32 years experience in healthcare, we understand it all starts on the human level, within the four walls of a healthcare facility. From minimizing waste to effective segregation that facilitates lower costs, enhanced compliance, and sustainable processing and treatment, Daniels Health focuses on technologies that minimize risk exposure to high-risk waste streams and reduces the volume of waste going to landfills. What's more, we have a strong understanding of who regulates the medical waste disposal industry, as well as how to comply. Learn more about the disposal of medical waste, regulations, and our treatment solutions through our Operations menu here.

Header Style: 
David Skinner

David Skinner

Executive VP - Sales

With over 20 years experience in healthcare and a genuine passion for reinventing the medical waste model of our era to achieve higher infection control standards, David is a walking almanac or, as we call him, the "skinnerpedia" of clinical knowledge.