Regulatory Requirements

The EPA Administrator, Gina McCarthy, signed the final rule on December 15, 2016 and the rule was published in the Federal Registrar (FR) on June 14, 2017.  The rule takes effect on July 14, 2017.


The new regulations purpose is to ensure that dentists properly collect and recycle ALL amalgam waste they generate during the placement or removal of amalgam restorations in order to contain mercury at its source. The new regulations emphasize compliance, documentation and enforcement.

What the Regulation Means For Your Office:

  • The regulations apply to anyone who either places or removes dental amalgam.
  • Included are permanent and temporary dental offices, hospitals, schools, clinics, mobile units and facilities owned by federal, state or local governments.
  • The regulation requires the installation, maintenance, monitoring, and recycling of an amalgam separator in addition to requiring compliance with ADA Best Management Practices (BMP’s) regarding the recycling of “scrap amalgam” (excess mix or carvings, empty capsules from pre-capsulated alloy, extracted teeth containing amalgam, in -line disposable traps and Evac-u-Traps from wet-vac systems).

Amalgam Separator:

  • Compliant to ISO 11143:2008 standard to operate at a minimum of 95% efficiency.
  • Timely recycling as recommended by the manufacturer
  • Provide required documentation

Scrap Amalgam Handling, Collection and Recycling:

  • Must include all items considered to be “scrap amalgam” (previously listed).
  • Requires the use of non-chlorinated line cleaners in the pH range of 6 to 8.
  • This waste must never be placed in with regular trash or bio-hazardous (red bag) waste.

Monitoring, Reporting and Record Keeping:

  • Monitoring and enforcement will be conducted by your local wastewater treatment facilities (POTW’s).

To Maintain Compliance, The Office Must Certify That:

  • It has installed and is properly maintaining, inspecting, and recycling an amalgam separator compliant to ISO 11143:2008 standard previously noted.
  • It adheres to all BMP’s and recycles all scrap amalgam.
  • Canisters, cartridges, or separator units are being recycled on a timely basis as per manufacturer’s requirements

States Already Required to Have Amalgam Separator Installed:

  • Connecticut
  • Maine
  • Massachusetts
  • Michigan
  • New Hampshire
  • New Jersey
  • New Mexico
  • New York
  • Oregon
  • Rhode Island
  • Vermont
  • Washington

Regulated Medical Wastes (RMW) State Regulations

For more information, contact DRNA at 800-360-1001