G ove r n men t Re lat ions
Environmental Protection Agency
Reinstates Final Ruling on Amalgam
Separators
On June 14, the Environmental Protection Agency (EPA)
reinstated a final rule requiring dental practices to install
amalgam separators. The rule was initially issued in
December 2016, but was withdrawn in January due to a
freeze on all new and pending regulations by the Trump
administration. The final rule was resubmitted and became
effective on July 14, 2017.
As of July 14, all new constructions subject to the ruling
must immediately comply with standards contained in the
rule. Existing practices will be given until July 14, 2020 to
come into compliance with the standards. Offices that
currently have separators installed will not be required to
immediately replace their units. Rather, those offices will be
grandfathered in for 10 years, or the lifetime of their current
units, whichever comes first.
The rule closely follows ADA Best Management Practices
for Amalgam Waste (BMP), and incorporates three of them
into the final rule:
1) Requiring the use of separators
2) Prohibiting the flushing of waste amalgam (including,
but not limited to, amalgam from chairside traps,
screens, vacuum pump filters, dental tools, cuspidors,
or collection devices) into a public owned treatment
works (POTW)
3) Prohibiting the use of oxidizing or acidic cleaners
(including, but not limited to, bleach, chlorine, iodine,
and peroxide that have a pH lower than 6 or greater
than 8) to clean dental unit water lines, chair-side traps
and vacuum lines that discharge into a POTW
Any separators installed must achieve at least 95 percent
removal efficiency and be compliant with either:
1) American National Standards Institute (ANSI) American
National Standard/American Dental Association (ADA)
Specification 108 for Amalgam Separators with
Technical Addendum
2) International Organization for Standardization (ISO)
11143 Standard
Amalgam separators are also required to be sized to
accommodate the maximum discharge rate or amalgam
process wastewater and separators must be inspected in
accordance with the manufacturer’s operating manual.
In the event that an amalgam separator is not properly
functioning, the office will have 10 days to either repair the
unit consistent with manufacturer instructions or replace
the unit with a compliant separator.
There are exemptions to the final rule. Any dental office
that exclusively practices one or more of the following
specialties is exempt: oral pathology, oral and maxillofacial
radiology, oral and maxillofacial surgery, orthodontics,
periodontics, and prosthodontics.
There are also exemptions for mobile dental units, for dental
offices that do not discharge wastewater into a POTW and
for dental offices that do not place amalgam and only
remove amalgam in unplanned or emergency situations.
In order to qualify for an exem ption due to only removing
amalgam in unplanned or emergency situations, the
removal of amalgam must occur at a frequency of less than
five percent of an office’s procedures. Based on available
data, EPA approximates that on average this equates to 9
removals per office per year.
In addition, there are inspection and recording keeping
requirements contained within the final rule. Existing dental
practices are required to submit a one-time compliance
report indicating that either they have separators installed
in their offices, or that they are exempt from the ruling, no
later than October 12,2020. New constructions must
submit their compliance report no later than 90 days
following the introduction of wastewater into a POTW. A
compliance report must also be submitted within 90 days
after there is a transfer in ownership of the practice
Although less than one percent of mercury released into
the environment from man-made sources comes from
dentistry, ADA has encouraged dental offices to follow BMP
in order to reduce discharges of used amalgam into
wastewater. In 2007, ADA amended its BMP to include the
use of amalgam separators that comply with the
International Organization for Standardization, a worldwide
federation of national standards bodies.
Regulations can be found at EPA Title 40 CFR Part 441. ADA
is developing resources to help dental offices with the
implementation of this final rule. More information about
compliance with this rule will be forthcoming.
If you have any questions about this new regulation, please
contact PDA at (800) 223-0016 and ask to speak with
Government Relations staff, or email kek@padental.org.
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