Dear Fellow Acupuncturists,
I hope this email finds you well. As part of ongoing efforts to ensure compliance with environmental and safety regulations, we want to remind you of the upcoming biomedical waste inspections that will be conducted in the near future.
If you’ve ever experienced a Biomedical Waste Generator inspection from your local county division of the Department of Health, I sympathize with you. When I first became licensed and opened my practice, I didn’t realize that a Waste Generator Permit was required—on top of the many city and county licenses. It wasn’t until an inspector from the Florida Department of Health (DOH) paid me a visit that I learned otherwise. As acupuncturists, unlike Western biomedical practitioners, we aren’t as familiar with Sharps procedures beyond what’s required for passing the Clean Needle Technique course for licensure.
I’m sharing this from experience—be prepared rather than caught off guard. If you haven’t been inspected yet, or, like me, had a permit but moved offices without notifying the DOH, take heed. Among all the permits required for address changes, I overlooked the Biomedical Waste Permit assuming that the exemption followed me to the new office address in a different county. My advice: Get your house in order and apply for the Biomedical Waste Generator permit ASAP. They will find you! I’ve attached a sample of the “We Found You” notice that I received.
I understand this might cause some anxiety—perhaps even nausea, headaches, or night sweats—but don’t worry. Below, I’ve outlined the necessary steps and documents you’ll need while you administer some formula to Calm the Shen. Plan to spend a weekend or a few days preparing. If you have staff, schedule time to train them. If you’re caught off guard, you could face citations for non-compliance, a short timeframe for corrective action, or even fines.
The Florida Department of Health has become more proactive in identifying SOME Sharps users, singling out acupuncturists when they apply for an occupational license. This triggers an inspection. However, once your office is permitted and documentation in the form of a monthly log or receipts shows the amount of waste generated in each 30-day period for the previous 12 months is less than 25 lbs, you may claim an exemption from further permitting. You will still have an inspection every 3 years instead of annually.
Why did I highlight “SOME”? Because the DOH hasn’t yet realized that chiropractors and physical therapists performing “dry needling” also qualify as Biomedical Waste Generators. Many of these practitioners use acupuncture needles without permits or DOH inspections. The inspectors I’ve encountered have been pleasant and helpful, but documentation must be current and accurate—so don’t cut corners. Most medical doctors’ offices already have biomedical waste policies, meaning acupuncture needle use is already addressed in their compliance systems.
Spread the word, fellow acupuncturists. Let your local DOH office know that we’re not the only ones using acupuncture needles. If you know chiropractors or physical therapists practicing dry needling, consider informing them—professionally and courteously—that they, too, must maintain proper records and permits. With this knowledge, DOH and county revenue will likely rise. They weren’t aware of dry needling practices in my area, but you can bet inspections will expand once they find this new revenue source.
Below is key information to help you obtain your Biomedical Waste Generator permit and pass your initial inspection:
Steps to Obtain Your Biomedical Waste Generator Permit:
- Complete a written plan for your business that includes all required items.
- Review 64E-16 F.A.C.
- Review Florida Statutes for Biomedical Waste.
- Contact your local Florida Department of Health office to pay via check or credit card. They offer remote payment options (Visa or Mastercard) via a credit card authorization form.
- My operating permit fee is $160 ($85 State fee + $75 County fee), but yours may vary by county.
Steps to Pass Your Initial Inspection:
- Have a completed operating/written plan covering all items required in 64E-16 F.A.C. Here is a Template you an use to create one
- Provide documented attestation of Biomedical Waste training for all staff handling biomedical waste (YouTube training video available: Training Video).
- Show proof of contract with a licensed/permitted transporter and retain 12 months of transporter pickup receipts.
- Keep a copy of 64E-16 F.A.C. and the Florida Statutes for Biomedical Waste on file.
- Ensure you have sharps/red bags and proper receptacles (cardboard boxes, etc.) on-site for inspection.
- Verify that red bags are approved and properly stamped (ASTMD) (see attached example).
- Maintain a designated storage area that is inaccessible to patients and on non-absorbent flooring.
- Label the outer side of red bags with your business name and address.
To stay ahead of compliance issues, I encourage you to review your facility’s biomedical waste management practices and ensure all documentation is in order. If you need assistance or have questions, feel free to reach out or contact your local DOH office.
Let’s stay ahead of the curve and avoid compliance pitfalls.
Best regards,
Dr. Stuart Shipe
FSOMA President
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