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Amalgam Separator Rule – July 14 Compliance Date

The Environmental Protection Agency’s (EPA) Effluent Limitations Guidelines and Standards for the Dental Category (the “Rule”) went into effect on July 14, 2017, with a required compliance date of July 14, 2020.

The Rule requires that most dental practices operate and maintain at least one amalgam separator that is International Standards Organization standard 11143 (ISO 11143) compliant, and follow two American Dental Association (ADA) Best Management Practices (BMPs) – a prohibition on the discharge of waste (or ‘‘scrap’’) amalgam to publicly owned treatment works (POTW) and a prohibition on the use of line cleaners that are oxidizing or acidic and that have a pH higher than 8 or lower than 6.

Current amalgam separators are generally ISO 11143 compliant. Please check with your manufacturer or distributor. However, if your practice operates an amalgam separator that does not meet the ISO 11143 standard, the Rule allows you to continue to operate that amalgam separator for its lifetime or 10 years, whichever is earlier. The Rule also provides new practice owners a grace period of 90 days from taking ownership to comply with its requirements.

Upon compliance, practices must submit a one-time compliance report to their control authority, and have maintenance and inspection records available.

The Rule exempts certain dental specialties – oral pathology, oral and maxillofacial radiology, oral and maxillofacial surgery, orthodontics, periodontics, and prosthodontics – as well as dental mobile units. The American Association of Endodontists (AAE) advocated for exemption for endodontic practices as well. However, the exemption was not granted based on the EPA’s determination that the exempted  “specialty practices are not expected to engage in the practice of amalgam restorations or removals, and are not expected to have any wastewater discharges containing dental amalgam.”

However, if an endodontic practice does not place or remove a significant amount of amalgam, it may qualify for an exemption. According to the EPA:

In the final rule, dental dischargers that do not place dental amalgam, and do not remove dental amalgam except in limited emergency or unplanned, unanticipated circumstances are exempt from any further requirements as long as they certify such in their One-time Compliance Report to their Control Authority. In this way, if, over time, the use of dental amalgam is phased out as a restorative material, the requirements of this rule will no longer apply.

Additionally, in March, 2020, the ADA issued a policy that it would not require penalties to be charged for noncompliance if such noncompliance is as a result of the pandemic. However, the EPA warns that this policy will not apply to practices for whom noncompliance is not actually a result of impact of the pandemic on the business.

The AAE expects that impending enforcement of the Rule will generate some inquiries. Please direct your questions to and we will do our best to answer them.