What you need to know about the EPA's new “Dental Amalgam Rule”.

The new EPA "Dental Rule" is about responsible management of amalgam waste in dental practices. The primary focus is on the use of amalgam separators that are ISO 11143:2008 certified at a separation rate of 95%. However, dental offices are now required to also use amalgam buckets for the disposal of all items that come in contact with amalgam.

When does the rule take effect?
The rule was published into the Federal Register on June 14, 2017 and went into effect on July 14, 2017.

Who is effected?
The new regulation effects dental offices that remove or replace amalgam restorations.
• Existing dental offices have three years to install a certified amalgam separator.
• New offices have 90 days to install an amalgam separator. New offices are classified as new businesses or transfer of ownership.
• The use of an amalgam waste bucket is now required for items such as: vacuum traps, contact and non-contact amalgam, teeth with amalgam, spent amalgam capsules and vacuum filters.

Who is exempt from this new rule?
Dental offices that do not place or remove amalgam fillings are exempt. Also, mobile units or offices that only specialize in:
• Oral Pathology
• Oral and Maxillofacial Radiology
• Oral and Maxillofacial Surgery
• Orthodontics
• Periodontics
• Prosthodontics

Is anything else needed for compliance?
Yes, all offices (exempt and non-exempt) must provide compliance documentation to the controlling authority. The controlling authority has yet to be determined, but will be decided during the three year implementation period. If your office is non-exempt you will need to show that you have a unit in place as well as an annual recycling service. You need to keep all recycling receipts on file in case of an inspection.

Questions to help you pick the right amalgam separator:
1. How many chairs are in your practice?

2. Does your office have a wet ring or dry vacuum system?
3. What is the space (height, width and depth) available for installing a separator?
4. How many chairs can be serviced by one unit?
5. What are the installation costs and who can install the unit?

6. Does the unit require access to a power supply?
7. Can office staff manage the separator maintenance or does it require outside services from a vendor?
8. How often does amalgam waste need to be removed from the unit?
9. Does the manufacturer provide an automatic system for removing and recycling the waste amalgam captured in the unit?
10. What is the initial cost of the unit?

11. What is the annual cost to maintain the unit?
12. Does the purchase of the separator require a contract for maintenance?

ADA Best Management Practices (BMPs)
The EPA "Dental Rule" on the proper handling of amalgam waste along with the adoption of ADA BMPs went into effect nationwide on July 14, 2017.
• Installation of an ISO 11143:2008 certified Amalgam Separator with a 95% or greater rate of separation.
• Dentist must recycle all mercury and stop using liquid mercury.
• All dental chairs must be equipped with chair-side traps and traps must be recycled.
• All central wet/dry vacuum traps must be recycled.
• All contact and non-contact amalgam, including teeth with amalgam, chair-side traps, vacuum filters and spent amalgam capsules, should be disposed of in an amalgam bucket.
• Use only non-chlorine or non-oxidizing disinfectants and neutral vacuum line cleaners with a pH > 6 and < 8.
• Amalgam Separator records showing name and address of disposal company, plus maintenance and service completed, must be kept for at least three years.
• A malfunctioning amalgam separator must be repaired or replaced no later than ten days after the malfunction