Thursday, January 25, 2018

Complying with the New EPA Rule on Amalgam and Amalgam Waste: A clinician Reference Guide

The following article first appeared in Dental Economics and appears here with their permission.

ON JULY 14, 2017, the Environmental Protection Agency (EPA) issued a final rule regarding the handling, recycling, and disposal of amalgam. The EPA issued the rule under the Clean Water Act, and it applies to discharges of amalgam pollutants into publicly owned treatment works (POTWs) by dental practices. This article will discuss key aspects of the rule that will impact dental practices.

Amalgam waste contains mercury, a persistent, bioaccumulative pollutant with neurotoxic effects on humans. The mercury in dental amalgam is a highly concentrated form that is easy to collect and recycle. Dental offices are the main source of mercury discharges to POTWs.1

Under the EPA’s new regulations, dentists who place or remove amalgam must collect and recycle the waste generated. The regulations emphasize compliance, documentation, and enforcement.

In some states, previous mandatory programs emphasized only equipment purchases, did not provide for inspection of offices, or mandate enforcement. However, the EPA’s new rule is more stringent. It demands proper recycling and documentation. It also establishes inspection mechanisms for offices suspected of noncompliance.

The rule applies to anyone who either places or removes amalgam in these settings: permanent and temporary dental offices, hospitals, schools, clinics, mobile units, and facilities owned by federal, state, or local governments.

The rule also requires the installation, maintenance, monitoring, and recycling of an amalgam separator, in addition to compliance with American Dental Association (ADA) Best Management Practices (BMPs) regarding the recycling of "scrap amalgam." This includes excess mix or carvings, empty capsules from precapsulated alloy, extracted teeth containing amalgam, in-line disposable traps, and vacuum traps from wet-vac systems.2

Amalgam separators must conform to the following standards:
• 2008 ISO 11143–certified to operate at a minimum of 99% efficiency
• Inspected at least monthly for proper operation
• Properly sized to incorporate all wastewater passing through it
• Canisters, cartridges, and other collecting units changed when full, as recommended by the manufacturer or annually—whichever comes first
• Maintained so unprocessed wastewater is not allowed to bypass the system and enter a drain3

In the list above, it is worth emphasizing that equipment changes must be made at least annually.

In regard to scrap amalgam handling, collection, and recycling, the following standards must be met:
• All items considered to be "scrap amalgam," as defined by ADA BMPs, must be properly recycled in containers both designed and designated for this purpose. These wastes must never be commingled with regular trash or biohazardous (red bag) waste.
• Only nonchlorinated line cleaners in the pH range of 6.0 to 8.0 may be used.4

Monitoring and enforcement will be conducted by local POTWs. Dentists will be categorized as Dental Industrial Users (DIUs), a less stringent category than Significant Industrial Users (SIUs).5 To maintain DIU status, an office must certify, among other things, that it has done the following:

• Installed and properly maintained, inspected, and recycled an amalgam separator that meets the 2008 ISO 11143 certification standard
• Adhered to all BMPs and recycled all scrap amalgam
• Maintained a written log of amalgam separator inspections, which were conducted at least monthly, as well as all notes related to that unit’s servicing
• Recycled all canisters, cartridges, or separator units at least annually6

Failure to comply may result in loss of DIU status and reversion of the dental office to the more intensive inspections of an SIU.

Baseline reports must be filed within 180 days of the effective date of the rule in order to establish a DIU status. These reports contain a significant amount of information about the practice, including the names of all dentists practicing there, along with their dental license numbers. Other documentation, including 90-day compliance and periodic-monitoring reports, will also need to be filed going forward.7

All reports listed above, along with service, maintenance, and inspection logs, plus dates of canister or cartridge changes, must be kept on file for at least three years.

The EPA calculated costs based on the number of treatment chairs in various configurations, from one chair up to seven or more chairs. When calculating a simple average across all groups, the initial cost to purchase and install an amalgam separator was approximately $1,172.50 per office. This does not include scrap amalgam recycling. The average annualized recurring cost to maintain and recycle the amalgam separator, based on only one recycling per year, was $588.75.8

References are available in the online version of this article. Visit and search the title of this article.

i. Data contained in tables on these pages were combined and simple averages were created across all categories of chair configurations. The numbers presented in this article represent those averages.

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