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Biomedical Waste Permits You May Need One
By Paul Watson Lambert, FCA General Counsel   
Friday, 10 December 2010
A chiropractor that generates more than twenty-five pounds of biomedical waste during each 30-day period is required by Florida Statute to apply for a permit from the Department of Health. Doctors generating some but less than twenty-five pounds during each 30-day period are entitled to apply for an exemption from permitting. Chiropractors who do not generate any biomedical waste need not apply for an exemption. 
The statute and Department of Health Rules governing generation, proper handling and disposal of biomedical waste are posted here
The Department of Health is now inspecting physicians’ offices to determine whether the office should have a medical biomedical waste generator permit. The department is authorized to impose fines up to $2,500 for each day that a physician is in violation of the statute.

There is no fee required to apply for an exemption. The application for biomedical waste generator permits exemption can be downloaded here .

Who generates biomedical waste?

Chiropractors using acupuncture needles, collecting blood, urine or tissue samples generate biomedical waste. Florida Statute 381.0098 (2)(a) defines “biomedical waste” as any solid or liquid waste which may present a threat of infection to humans. The term includes, but is not limited to, nonliquid human tissue and body parts; laboratory and veterinary waste which contains human-disease-causing agents; discarded disposable sharps; human blood, blood products, and body fluids; and other materials which in the opinion of the department represent a significant risk of infection to persons outside the generating facility. ) 1
“Sharps” mean those biomedical wastes which as a result of their physical characteristics are capable of puncturing, lacerating, or otherwise breaking the skin when handled.2

The statute defines “biomedical waste generator” as a facility or person that produces or generates biomedical waste. The term includes, . . .physicians’ offices . . . .3

Who must apply for a permit?

All persons who generate, store, or treat biomedical waste shall obtain a permit from the department prior to commencing operation, except that a biomedical waste generator generating less than 25 pounds of biomedical waste in each 30-day period shall be exempt from the registration and fee requirements of this subsection.4

It is recommended that chiropractic physicians generating some biomedical waste but less than twenty-five pounds during each 30-day period keep a log or other documentation demonstrating that amount of generation to substantiate entitlement to the exemption from obtaining a permit and qualifying for an exemption from the Department of Health.

What is proper handling of biomedical waste?

The Rules of the Department of Health set out the proper procedures for handling, storing and transporting biomedical waste and decontaminating surfaces. Those rules are posted here . Chiropractors who generate biomedical waste should download the rules and become familiar with the requirements of developing written office policies for collecting, handling, storing and transporting biomedical waste.

Does a chiropractor need a special permit to transport biomedical waste to a place of disposal?

Any person who transports biomedical waste within the state must register with the Department of Health prior to engaging in the transport of biomedical waste in accordance with rules adopted by the department.5 However, the statute and department rule exempts biomedical waste generators transporting less than twenty-five pounds of their own biomedical waste, in their own transport vehicle, on any single occasion, are exempt from transporter registration, fee, and placarding requirements of the department rules.6 Therefore, a chiropractor transporting less than twenty-five pounds of biomedical waste from his or her office in his or her own personal vehicle to a biomedical waste disposal facility does not need a permit or need to comply with requirements relating to identifying placards on the vehicle imposed by the department rules.

Will chiropractors be inspected by the Department of Health?

Department personnel shall inspect registered transport vehicles, permitted generators, storage, and treatment facilities at least once a year. Those facilities exempted from the registration and fee requirements shall be inspected at least once every three years.7 Reinspections may be conducted when a facility is found to be in non-compliance with the department rules.8 Results of each inspection shall be recorded on a form provided by the department.9

Therefore, a chiropractor that generates biomedical waste is going to be inspected every year if the amount generated is more than twenty-five pounds in any 30-day period and holds a permit. A chiropractor that generates less than twenty-five pounds of biomedical waste in any 30-day period and is exempt from permitting will be inspected once every three years.
Department of Health Rule 64E-16.002(4) specifies which body fluids are
considered “biomedical waste” and reads:

(4) Body fluids - Those fluids which have the potential to harbor pathogens, such as human
immunodeficiency virus and hepatitis B virus and include blood, blood products, lymph, semen,
vaginal secretions, cerebrospinal, synovial, pleural, peritoneal, pericardial and amniotic fluids. In
instances where identification of the fluid cannot be made, it shall be considered to be a regulated
body fluid. Body excretions such as feces and secretions such as nasal discharges, saliva,
sputum, sweat, tears, urine, and vomitus shall not be considered biomedical waste unless visibly
contaminated with blood.
See Florida Statute 381.0098(2)(d)

See Florida Statute 381.0098 (2)(b)

4 See Florida Statute 381.0098(4)(a)
See Florida Statute 381.0098(5)

See Florida Statute 381.0098(5) and Rule 64E-16.009)(1)

7 See Rule 64E-16.010(1)

8 Ibid

9 Ibid