Dental Amalgam Requirements for Dental Practices

On June 14, 2017, the United States Environmental Protection Agency (EPA) released a new rule to reduce discharges of mercury from dental offices into publicly owned treatment works (POTWs). The Dental Office Category regulation is codified at 40 CFR Part 441. Dental offices discharge mercury present in amalgam used for fillings. Amalgam separators are a practical, affordable and readily available technology for capturing mercury and other metals before they are discharged into sewers that drain to POTWs. Once captured by a separator, mercury can be recycled. EPA expects compliance with this final rule will annually reduce the discharge of mercury by 5.1 tons as well as 5.3 tons of other metals found in waste dental amalgam to POTWs.

Who is affected by the Dental Rule?

• Applies to dental offices, dental schools, dental clinics, and government-operated dental facilities.
• Does not apply to one or more of the following practices exclusively: oral pathology, oral & maxillofacial radiology/surgery, orthodontics, periodontics or prosthodontics and mobile units.
• All dental offices must submit a One-Time Compliance Report regardless of excluded practices or not.

When will this rule affect dental offices?

• The effective date of this rule is July 14, 2017.
• New dental offices must submit a One-Time Compliance Report within 90 days following the introduction of wastewater to the sanitary sewer.
• Transfer of ownership requires submittal of a One-Time Compliance Report within 90 days after a transfer of ownership.
• Existing dental offices must submit a One-Time Compliance Report no later than Oct. 12, 2020.
• Existing separator(s) or devices must be replaced by July 14, 2027 or the end of service life (whichever is sooner) with a compliant amalgam separator.

What equipment is required to comply?

• Each covered facility must already have or must install an amalgam removal and collection system to prevent amalgam from being sent to the sanitary sewer system. The amalgam removal system must consist of one or more amalgam separators meeting either the American National Standards Institute (ANSI) or the American National Standard/American Dental Association (ADA) Specification 108 for Amalgam Separators (2009) with Technical Addendum (2011), the International Organization for Standardization (ISO) 11143 Standard (2008) or subsequent versions so long as that version requires amalgam separators to achieve at least a 95 percent removal efficiency.
• The system must be sized to accommodate the maximum discharge rate of amalgam process wastewater.
• The amalgam separator(s) must be inspected in accordance with the manufacturer’s operating manual to ensure proper operation and maintenance of the separator(s) and to confirm that all amalgam process wastewater is flowing through the amalgam retaining portion of the amalgam separator(s).
• A malfunctioning unit must be repaired or replaced no later than 10 business days after the malfunction is discovered.

Are any changes in operation required?

This rule requires dental dischargers to adopt two specific best management practices (BMPs) in addition to the equipment requirements:

• Waste amalgam, including but not limited to dental amalgam from chair-side traps, screens, vacuum-pump filters, dental tools, cuspidors or collection devices must not be discharged to a POTW.
• Dental unit water lines, chair-side traps and vacuum lines that discharge amalgam process wastewater to a POTW must not be cleaned with oxidizing or acidic cleaners, including but not limited to bleach, chlorine, iodine and peroxide that have a pH lower than six or greater than eight.

What paperwork and recordkeeping is required?

All dental offices must submit a One-Time Compliance Report to the Miami-Dade County Department of Regulatory and Economic Resources, Division of Environmental Recourses Management (RER-DERM). The dental discharger must maintain and make available for inspection a copy of the One-Time Compliance Report as long as it is in operation or until ownership is transferred. The One-Time Compliance Report must be signed and certified by a responsible corporate officer, a general partner or proprietor if the dental discharger is a partnership or sole proprietorship, or a duly authorized representative in accordance with the requirement of 40 CFR 403.12(l). Dental dischargers or an agent or representative of the dental discharger must maintain and make available for inspection in either physical or electronic form for a minimum of three years the following:

• Documentation of the date, person(s) conducting the inspection and results of each inspection of the amalgam separator(s) or equivalent device(s) and a summary of follow-up actions, if needed.
• Documentation of amalgam-retaining container or equivalent container replacement (including the date, as applicable).
• Documentation of all dates that collected dental amalgam is picked up or shipped for proper disposal in accordance with 40 CFR 261.5(g)(3) and the name of the permitted or licensed treatment, storage or disposal facility receiving the amalgam retaining containers.
• Documentation of any repair or replacement of an amalgam separator or equivalent device, including the date, person(s) making the repair or replacement and a description of the repair or replacement (including make and model).
• The manufacturer’s operating manual for the current device.

Resources and additional information

Visit the following pages on the EPA website for detailed information: Development Document, Effluent Guidelines, Frequently Asked Questions and Fact Sheet. The Dental Office Point Source Category regulation is codified at 40 CFR Part 441.

View the One-Time Compliance Report.

For additional information, email [email protected] or [email protected].

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