EPA Amalgam Separator Rule

As of July 14, 2017, most dental offices that discharge wastewater into a publicly owned treatment work (POTW) must install, maintain and monitor an amalgam separator that complies with one of the following: 
  • American National Standards Institute (ANSI) American National Standard/American Dental Association (ADA) Specification 108 for Amalgam Separators (2009) with Technical Addendum (2011)
  • International Organization for Standardization (ISO) 11143 Standard (2008) 
  • Subsequent versions – as long as the separator achieves at least 95% removal efficiency
Existing offices not exempt from the rule must install a compliant separator no later than July 14, 2020; newly constructed or purchased offices must immediately install a separator and submit a one-time compliance report within 90 days of taking ownership. 

The following offices are exempt from installing an amalgam separator:
  • Offices that exclusively practice at least one of these specialties: oral pathology; oral & maxillofacial radiology; oral &maxillofacial surgery; orthodontics; periodontics; prosthodontics 
  • Mobile dental units or offices that discharge wastewater into a private septic system
  • Offices that do not place amalgam and only remove amalgam in limited, emergency or unanticipated circumstances (estimated less than 5% of procedures per year)

Offices that already have a separator installed can continue to operate their existing separator for the lifetime of the unit, or until July 14, 2027, whichever comes first. However, these offices are subject to the other rule requirements. 

Dental offices will be required to submit a one-time compliance report by October 12, 2020 and retain a copy of the filed report for the lifetime of practice ownership.  Dental practices that are exempt from the rule due to specialty, or because they do not discharge wastewater into a POTW (mobile units or offices with private septic systems) do not need to file these reports. 

One-time compliance reports must be submitted to your Control Authority.  In Pennsylvania, the Control Authority will either be the local POTW or the EPA regional office, depending on whether the local POTW has an EPA approved pretreatment program.  Contact your local POTW or EPA regional office to find out who your Control Authority is.  Your Control Authority will also determine the form you will use to submit your report. 

 
Offices with installed amalgam separators are also required to comply with the following: 

  • Monitor the separator according to manufacturer’s guidelines
  • Inspect separators at least once a month to ensure proper operation and maintenance of the separator
  • Replace/Repair any malfunctioning separators according to manufacturer instructions within 10 business days of discovering the defect
  • Maintain separators by replacing amalgam retaining cartridges, separator canisters or units as directed by the manufacturer, or annually, whichever comes first
  • Do not discharge waste amalgam from chair-side traps, screens, vacuum pump filters, dental tools, cuspidors, or collection devices to a POTW. In other words, no flushing waste down the drain. 
  • Do not use oxidizing, acidic cleaners when flushing dental unit water lines, chair-side traps and vacuum lines.  Do not use bleach, chlorine, iodine or peroxide cleaning agents that have a pH of lower than 6 or higher than 8. 
  • Install the separator unit so that it receives all amalgam process wastewater and that it is sized to incorporate all wastewater than may pass through it.
     

In addition, dental practices must retain any records of the following for a 3 year time period:

  • Any reports filed
  • Visual inspection log – including the date, person(s) conducting the inspection, the results of each inspection and a summary of follow-up actions (if needed)
  • Any repair or replacement- including the date, person(s) making the repair/replacement, a description of the repair/replacement and documentation of the amalgam retaining container replacement (including date)
  • Disposal records – including all dates that collected dental amalgam is picked up or shipped for proper disposal, and the name of the permitted or licensed treatment, storage or disposal facility receiving the amalgam retaining containers
  • Manufacturer’s current operating manual for the device in place

Remember, a copy of the one-time compliance report must be retained for the duration of ownership of the practice. 

For additional information about the EPA Amalgam Separator Rule, please visit ADA’s website at: http://success.ada.org/en/regulatory-legal/amalgam. You may also contact the PDA Central Office at (717) 234-5941, or send an email

PDA endorses PureLife’s ECO II amalgam separator through PDA’s Endorsed Vendor Program. This separator is complaint with ISO 11143 Standard and is available at member-exclusive pricing. To learn more, visit the PDAIS website or call (877) 777-3303 to take advantage of this PDA member-only offer.