Except for a limited time in the past (June 24, 1989 to June 21, 1991) and within a limited range (New York, New Jersey, Connecticut, Rhode Island, and Puerto Rico) the generation, handling, transportation, and disposal of medical waste is not regulated by the US EPA under the Resource Conservation and Recovery Act (RCRA). For more information about medical waste and RCRA read: US EPA Regulations for the Management of Medical Waste. With the expiration of the provisions of the Medical Waste Tracking Act of 1988, US EPA shifted responsibility for regulation of Medical Waste disposal to the individual states.
If your state is like most I am familiar with, the regulation of medical waste (sometimes also known as: Regulated Medical Waste, Biomedical Waste, Infectious Waste, or Potentially Infectious Medical Waste) is limited to a solid or liquid waste which presents a threat of infection to humans or has come in contact with human or animal blood, tissue, fluids, excretion, etc. or devices that have come in contact with any of them. Also – again, based on my experience – most states limited the sources of Regulated Medical Waste mostly to hospitals, dialysis clinics, dental offices, health maintenance organizations, surgical clinics, medical buildings, physicians’ offices, laboratories, veterinary clinics, funeral homes, tattoo parlors, and the like.
Not so in Florida. This article will focus on the State of Florida’s inclusion of discarded sharps from industry, manufacturing, or other non-medical commercial entities as Biomedical Waste and what you must do as a Biomedical Waste Generator in Florida to comply with the regulations.
The regulations are found in the Florida Administrative Code (FAC) 64E-16 and are administered by the Florida Department of Health. However, local management and enforcement of the regulations is tasked to the county level Biomedical Waste Coordinator; be sure to check with your County Biomedical Waste Coordinator to ensure compliance and to submit the applications for permit or exemption (more on that later). The Florida Department of Health website for its Biomedical Waste Program has a lot of good information for anyone involved in the generation of Biomedical Waste in Florida, including private citizens. There you will also find the reporting and recordkeeping forms necessary for Biomedical Waste Generators.
We’ll begin at the definitions (64E-16.002) for the terms used in this part to be sure we are clear on the terms used by the Department in determining who is subject to these regulations:
Biomedical waste – Any solid or liquid waste which may present a threat of infection to humans, including nonliquid tissue, body parts, blood, blood products, and body fluids from humans and other primates; laboratory and veterinary wastes which contain human disease-causing agents; and discarded sharps. The following are also included…
I added the emphasis above to bring your attention to this distinctive aspect of Florida’s regulations. I have confirmed in conversation with state and county level officials that this definition includes a discarded sharp even if it is not contaminated or associated with the other materials described in the definition.
You might hope that the definition of a Biomedical Waste Generator will exclude a facility from regulation if it is not associated with medical procedures? Unfortunately, no.
Biomedical waste generator – A facility or person that produces biomedical waste.
We’ll stop the definition there and jump to the definition of a “person”:
Person – Any individual, partnership, corporation, association, or public body engaged in the generation, storage transport, or treatment of biomedical waste.
This clearly broadens the scope of Florida’s Biomedical Waste regulations to include any facility, not just one in the medical field, that generates a Biomedical Waste, which, as we saw earlier, will include discarded sharps generated from non-medical procedures.
What then is a sharp? Is it limited solely to hypodermic needles? Again, unfortunately, no.
Sharps – Objects capable of puncturing, lacerating, or otherwise penetrating the skin.
That’s more than just hypodermic needles, and could include razor blades, knife blades, broken glass, scalpels, and more. So, if your business discards an object that meets the definition of a sharp, then you meet the definition of a Biomedical Waste generator in Florida and must comply with all of the applicable regulations for a Biomedical Waste Generator found at 64E-16.003 through .013 of the FAC and summarized in this article. If you are a transporter or treatment facility of Biomedical Waste or if you generate other Biomedical Waste besides discarded sharps, you will have to review the regulations yourself for your compliance requirements.
All Biomedical Waste mixed with either a hazardous waste or a radioactive waste must be managed as a hazardous or radioactive waste respectively. Any other waste, if mixed with a Biomedical Waste must be managed according to this section as a Biomedical Waste. That means that a few syringes or razor blades thrown into a dumptser may require the entire dumpster to be managed as a Biomedical Waste.
As a Biomedical Waste Generator you must have a written operating plan to manage your Biomedical Waste. I suggest you use the template plan available on the Department’s website: Biomedical Waste Operating Plan.
You must also provide initial and annual refresher training for all personnel who handle Biomedical Waste. Training must include the proper management procedures documented in the facility’s Biomedical Waste Operating Plan and all of the applicable requirements of 64E-16 of the FAC.
Storage of discarded sharps at a Generator’s facility is limited to ≤30 days after the container is sealed. Discarded sharps must remain sealed until treatment. Whether stored indoors or out (both are acceptable), a storage area for Biomedical Waste must have:
- Restricted access.
- Be located away from pedestrian traffic.
- Be free of vermin and insects.
- Maintained in a sanitary condition.
- Must be constructed of smooth, easily cleanable materials, and impervious to liquids.
An outdoor storage area, in addition to that listed, must be conspicuously marked with the international biological hazard symbol. Discarded sharps, unlike other Biomedical Waste, may not be packaged in bags, instead they must be discarded at the point of origin into a sharps container which is defined as:
Sharps container – A rigid, leak and puncture resistant container, designed primarily for the containment of sharps, clearly labeled with the phrase and international biological hazard symbol as described in 64E-16.004(2)(a), FAC, and manufactured with dyes meeting the requirements for incidental metals as described in section 64E-16.004(2)(b), FAC.
This means the container for your discarded sharps must have the international biological hazard symbol and one of the following phrases:
- BIOMEDICAL WASTE
- BIOHAZARDOUS WASTE
- INFECTIOUS WASTE
- INFECTIOUS SUBSTANCE
Outer containers must be rigid, leak-resistant and puncture-resistant.
Additional requirements specific to packaging for discarded sharps:
- Needles and scalpel blades shall not be placed directly into double-walled corrugated containers.
- A discarded sharps containers must be sealed when full and remain sealed when in storage. A sharps container is considered full when the materials placed into it reach the designated fill line or when no additional material can fit without cramming.
- The holder for a permanently mounted sharps container must be marked with the required symbols and phrases if the information on the container is covered by the holder.
- A reusable sharps container shall be emptied only into a treatment cart or directly into a treatment unit. They must be manufactured of smooth, easily cleanable materials, and shall be decontaminated after each use.
- The international biological hazard symbol shall be at least one inch in diameter for inner packages and at least six inches in diameter for outer packages.
A sharps container must be labeled with the generator’s name and address if the container will be shipped off-site for treatment. If the sharps container is placed in a larger bag prior to off-site transportation the labeling requirements now apply to the outer bag while the inner container now no longer requires the generator’s name and address label. The use of a generator specific label created by the transporter with information to identify the generator satisfies this requirement. In addition, the outer packaging must also be labeled with the transporters name, address, registration number, and 24-hour telephone number prior to transport.
The transporter of your discarded sharps must be registered with the Florida Department of Health as a Biomedical Waste Transporter. If you’re unsure of your transporter, review the Florida Department of Health’s list of Registered Biomedical Waste Transporters. The remainder of the section explains the requirements for compacting Biomedical Waste, but that won’t be related in this article since discarded sharps may not be compacted.
This section documents the requirements for the treatment of Biomedical Waste. You will need to review this section in detail if you are interested in treating your discarded sharps on-site.
A Biomedical Waste Transporter may not accept a load for transportation unless the load has been properly segregated, packed, and labeled. This puts the burden of compliance on you as the generator of the Biomedical Waste. Don’t rely on your transporter to ensure your compliance. The Biomedical Waste Transporter must provide you with a receipt of the pickup. The form of this receipt may vary depending on the transporter, but make sure you receive something from them for the shipment. Also keep in mind that your shipment of discarded sharps may be regulated as a Division 6.2 Infectious Substance by the US Department of Transportation. This will mean additional responsibilities for you as a shipper of a hazardous material. The remainder of this section details the requirements for registered Biomedical Waste Transporters and won’t be addressed in this article.
This section describes how a Biomedical Waste Transporter will register with the Florida Department of Health, and is not of concern to a generator of discarded sharps. However, a generator may transport a Biomedical Waste, including discarded sharps, without registration, fees, or being subject to other requirements of these regulations if the following conditions are met:
- Transporting only their own waste.
- Less than 25 pounds of Biomedical Waste on any single occasion.
- In their own transport vehicle.
Permitted Biomedical Waste generators will be inspected at least once per year by the Florida Department of Health with re-inspections more frequently if violations are found.
All Biomedical Waste Generators must submit an initial application for a permit and pay an $85 fee. This permit will expire on September 30th of each year and must be renewed prior to this date by submittal of an application form and fee. After at least one year of permitted operation a generator may submit an application for exemption instead of the application for annual permit renewal. The exemption from permit will be granted only if the generator provides documentation that proves it generates medical waste below threshold amounts. Documentation can be in the form of a monthly log or transporter receipts. In order to qualify for the exemption from permit you must not generate 25 pounds or more of regulated Biomedical Waste in any 30-day period for the previous 12 months.
A county Biomedical Waste Coordinator I spoke with summarized the process as follows:
- Submit initial application with $85 fee.
- You will then be inspected by the County Coordinator.
- If you pass the inspection a permit will be issued.
- You must then keep records of your Biomedical Waste generation for the next 12 months.
- If your generation is below the threshold, at the time your annual permit renewal application is due you may submit the application for permit exemption.
- If acceptable to the Department, you will not need to submit a permit application again unless your Biomedical Waste generation later exceeds the threshold. However, you must still comply with the other requirements of 64E-16 applicable to Biomedical Waste Generators.
This section details the fee schedule for permits required for generators, transporters, treatment facilities, and storage facilities. As a generator you should be aware that permit renewal application fees received after October 1st are $105.
A Biomedical Waste Generator who violates the regulations of 64E-16 is subject to being charged with a second degree misdemeanor and fines of up to $2,500/day.
All records related to Biomedical Waste must be maintained for three years and be available for review upon request by Department officials.
There you have it. Something as simple as razor blades used to cut open cardboard boxes, needles used to inject a resin right where you need it, or broken glass must be regulated as a Biomedical Waste in Florida. A conversation I had with a Department Official led me to believe that this is not a high enforcement priority for them, and they are not looking to issue fines on this. However, the official did say that if the presence of needles or other sharps in your trash is noted by someone; say a member of the public, or landfill employee, or disgruntled employee and they make it an issue with the public, then the Department will be forced to take action.
Review the regulations, take stock of your operations, and then decide for yourself what steps you will take to maintain compliance.
Remember to check out the Florida Department of Health website for its Biomedical Waste Program, it has a lot of very helpful information.
As always, don’t hesitate to contact me with any questions you may have about the management of hazardous waste, universal waste, used oil, medical waste, or the transportation of hazardous materials in Florida or nationwide. I’m glad to take your questions.