Dental Amalgam Requirements for Dental Practices

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

- The Dental Rule (the Rule) applies to dental offices, dental schools, dental clinics and government-operated dental facilities
- Does not apply to Dental dischargers that exclusively practice one or more of the following specialties: 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 dental specialty
- Dental dischargers commencing operations on or after July 14, 2017, must be in compliance with the current standards prior to discharging to the POTW. A One-Time Compliance Report certifying compliance must be submitted within 90 days of the first discharge to POTW
- All transfer of ownerships require the submittal of a One-Time Compliance Report within 90 days from the transfer of ownership date
- Dental dischargers in operation prior to July 14, 2017, must replace their existing separators or devices no later than July 14, 2027, or the end of service life (whichever is sooner), with a compliant amalgam separator
- Each covered facility subject to the Rule must have an amalgam removal and collection system to prevent amalgam discharge 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 requiring amalgam separators to achieve a minimum 95 percent removal efficiency
- All systems must be sized to accommodate the maximum discharge rate of amalgam containing 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
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
All dental offices located within Miami-Dade County must submit a One-Time Compliance Report to the Department of Regulatory and Economic Resources, Division of Environmental Recourses Management (RER-DERM). Dental offices in operation must maintain and make available for inspection a copy of the One-Time Compliance Report until operations cease or 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 applicable)
- Documentation of amalgam-retaining container or equivalent container replacement (including the date, as applicable)
- Documentation of all pickup and/or ship dates of collected dental amalgam 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 all repairs and/or replacements of amalgam separators or equivalent devices, 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

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Online Services

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Create a new miamidade.gov account

Elected Officials

County Agencies

Public Records & Open Data

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Dental Amalgam Requirements for Dental Practices

Who is affected by the Dental Rule?

When will this rule affect dental offices?

What equipment is required to comply?

Are any changes in operation required?

What paperwork and recordkeeping is required?

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