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Amalgam Separator Requirements - Q&A

October 01, 2020 4421

The Environmental Protection Agency (EPA) finalized a long-anticipated rule that requires dental facilities nationwide to install amalgam separators and to implement two best-management practices (BMPs). The rule was published on June 14, 2017, and is effective 30 days later on July 14, 2017. Most dental facilities must comply with the rule by July 14, 2020. New dental facilities (does not include ownership change) that start operations after July 14, 2017, must comply immediately with the rule. A local sanitation agency may elect to set a compliance date earlier than July 14, 2020.

Most dental facilities must install amalgam separators that are compliant with either the American National Standards Institute (ANSI) American National Standard/American Dental Association (ADA) Specification 108 for Amalgam Separators (2009) With Technical Addendum (2011) or 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. Dental facilities also must collect all waste amalgam, including amalgam in chairside traps, screens, vacuum pump filters, instruments or collection devices. Dental facilities are prohibited from using line cleaners that have a pH lower than 6 or greater than 8, are acidic or contain oxidizers, including but not limited to bleach, chlorine, iodine and peroxide. California has additional amalgam waste management requirements.

What dental practices are exempt from the rule?

The following specialty practices are not expected to discharge dental amalgam in their wastewater and therefore are exempt from the federal rule.

  • Oral pathology
  • Oral and maxillofacial radiology
  • Oral and maxillofacial surgery
  • Orthodontics
  • Periodontics
  • Prosthodontics

Mobile dental units and dental practices that discharge to septic system are not subject to the federal rule. Septic system service providers may place conditions on dental wastewater discharges. A dental facility which certifies it does not place dental amalgam and does not remove amalgam except in limited circumstances are exempt.

The effective date of the rule is July 14, 2017. The compliance dates are based on the effective date of the rule.

  • July 14, 2020: Dental facilities operating before June14, 2017, have three years from the effective date of the rule to install the separator and comply with BMPs.
  • October 12, 2020: Dental facilities operating before June 14, 2017, must submit a one-time Compliance Report no later than 90 days after the compliance date.
  • 90 days: Dental facilities in operation before June 14, 2017, that have a change in ownership must submit a one-time Compliance Report within 90 days of the ownership change.
  • Immediate/90 days: New dental facilities opened for business on or after June 14, 2017, must comply immediately with the rule and submit a one-time Compliance Report to the local sanitation agency within 90 days of discharging to the sanitary sewer system.
  • Annual: Submit periodic monitoring report to local sanitation agency.

What are the requirements specific to the amalgam separator?

Separators must be compliant with either the American National Standards Institute (ANSI) American National Standard/ American Dental Association (ADA) Specification 108 for Amalgam Separators (2009) With Technical Addendum (2011) or 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 chosen separator(s) must be sized to accommodate the maximum discharge rate of wastewater from dental units.

Separators must be inspected and maintained in accordance with the respective manufacturer’s operating manual. Each dental facility must confirm that all amalgam process wastewater is flowing through the amalgam-retaining portion of the amalgam separator. When a separator is not functioning properly, it must be repaired consistent with manufacturer

instructions or replaced as soon as possible, but no later than 10 business days after the malfunction is discovered, with a unit that meets the requirements of the EPA rule.

The amalgam-retaining units (cartridges) must be replaced in accordance with the schedule specified in the manufacturer’s operating manual or when the cartridge has reached the maximum level, as specified in the operating manual, at which the amalgam separator can perform to the specified efficiency, whichever comes first.

Are alternatives to amalgam separators allowed?

Yes, because the EPA wants to leave the door open for technologies that may be developed in the future. The alternative amalgam removal device must meet the following requirements:

  • Removal efficiency of at least 95 percent of the mass of solids from all “amalgam process wastewater.” The removal efficiency must be calculated in grams recorded to three decimal places on a dry weight basis. The removal efficiency must be demonstrated at the maximum water flow rate through the device as established by the device manufacturer’s instructions for use.
  • The removal efficiency must be determined using the average performance of three samples. The removal efficiency must be demonstrated using a test sample of dental amalgam that meets the following particle size distribution specifications: 60 percent by mass of particles that pass through a 3150 µm sieve but which do not pass through a 500 µm sieve, 10 percent by mass of particles that pass through a 500 µm sieve but which do not pass through a 100 µm sieve and 30 percent by mass of particles that pass through a 100 µm sieve. Each of these three specified particle size distributions must contain a representative distribution of particle sizes.
  • The device must be sized to accommodate the maximum discharge rate of amalgam process wastewater.
  • The device must be accompanied by the manufacturer’s manual providing instructions for use including the frequency for inspection and collecting container replacement such that the unit is replaced once it has reached the maximum filling level at which the device can perform to the specified efficiency.
  • The device must be inspected and maintained in accordance with the manufacturer’s operation manual to ensure proper operation, including confirmation that amalgam process wastewater is flowing through the amalgam-separating portion of the device.
  • In the event that a device is not functioning properly, it must be repaired consistent with manufacturer instructions or replaced with a unit that meets the requirements of the federal rule as soon as possible, but no later than 10 business days after the malfunction is discovered.
  • The amalgam-retaining unit of the device must be replaced as specified in the manufacturer’s operating manual or when the collecting container has reached the maximum filling level, as specified in the operating manual, at which the amalgam separator can perform to the specified efficiency, whichever comes first.
  • The demonstration of the device must be documented in the one-time Compliance Report.

What are the documentation and record-keeping requirements?

Compliance Report.

All dental facilities, including those exempted from the rule, must submit a one-time Compliance Report. Dental facilities operating before June 14, 2017, must submit to local sanitation agencies a one-time Compliance Report no later than 90 days after Oct. 12, 2020, or 90 days after a transfer of ownership. Dental facilities starting on or after June 14, 2017, must submit a one-time Compliance Report no later than 90 days following discharge to the sanitary sewer system.

Contents.

The EPA did not develop a specific Compliance Report form, but has specified what must be included in it.

It is expected that local sanitation agencies will develop their own forms for distribution to dental facilities in their respective service areas.

Facilities that do not place or remove amalgam must include in the report the facility name, physical address, mailing address, contact information, name of the operator(s) and owner(s) and a certification statement that the dental discharger does not place dental amalgam and does not remove amalgam except in limited circumstances.

Facilities required to comply with the rule must include in the report:

  • The facility name, physical address, mailing address and contact information.
  • The name(s) of the operator(s) and owner(s).
  • A description of the operation at the dental facility including:
    • The total number of chairs.
    • The total number of chairs at which dental amalgam may be present in the resulting wastewater.
    • A description of any existing amalgam separator(s) or equivalent device(s) currently operated to include, at a minimum, the make, model and year of installation.
  • A certification statement that the amalgam separator(s) or equivalent device is designed and will be operated and maintained to meet the requirements of the rule.
  • Certification statement that the dental facility is implementing BMPs specified in the rule and will continue to do so.
  • The name of the third-party service provider that maintains the amalgam separator(s) or equivalent device(s) operated at the dental office, if applicable. Otherwise, a brief description of the practices employed by the facility to ensure proper operation and maintenance in accordance with the rule.

Signature and Certification.

The Compliance Report must be signed and certified by a responsible corporate officer, a general partner or proprietor or a duly authorized representative. The Compliance Report must be maintained and made available for inspection in either physical or electronic form.

Inspection and Maintenance Records.

Dental facilities must maintain and make available for inspection in either physical or electronic form for a minimum of three years:

  • Documentation of the date, person(s) conducting the inspection, 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 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).

Dental facilities may create their own forms for tracking inspections and maintenance or utilize the sample form.

Manufacturer’s Operating Manual.

Dental facilities must maintain and make available for inspection in either physical or electronic form the manufacturer’s operating manual for the current device(s).

Our practice does not place amalgams – why is our practice not exempt from this requirement?

The purpose of amalgam separators and BMPs is to prevent dental amalgam from entering the environment where it can be converted to a bioavailable form of mercury. Dental amalgam removed from teeth is a major source of mercury in wastewater processed by sanitation agencies for discharge to bays, rivers and lakes.

My practice already has an amalgam separator – am I required to replace it?

Amalgam separators that were installed prior to June 14, 2017 and are functioning properly, may continue to be operated until June 14, 2027. The newer amalgam separators are known to operate more efficiently than older models. Sanitation agencies that already require amalgam separators will contact dental facilities to submit a new compliance report.

How does the new rule affect the purchase of a dental practice or the opening of a new dental practice during the compliance period?

If facility ownership changes during the three-year compliance period, the new owner “inherits” the compliance timeline of the previous owner because the practice is not considered a new source of wastewater discharge. The new owner must notify the sanitation agency within 90 days of the change in ownership.

If practice ownership changes after the compliance period, the new owner has 90 days to submit a one-time compliance report to the sanitation agency.

A newly built dental facility or a dental facility that occupies space not previously occupied by a dental facility are considered new dental wastewater dischargers. A new dental wastewater discharger is required within 90 days of discharging wastewater to comply with the rule, which is install an amalgam separator, implement BMPs and submit a one- time Compliance Report.

What are the additional BMPs required by California?

California adopted universal waste rules in 2002 that require dental facilities to adhere to the following BMPs:

  • Do not rinse amalgam-containing traps, filters or containers in the sink.
  • Do not place amalgam, elemental mercury, broken or unusable amalgam capsules, extracted teeth with amalgam or amalgam-containing traps and filters with medical “red-bag” waste or regular solid waste.
  • Recycle, or manage as hazardous waste, amalgam, elemental mercury, broken or unusable amalgam capsules, extracted teeth with amalgam and amalgam-containing waste from traps and filters. Empty dental amalgam capsules containing no visible materials may be disposed of as a nonhazardous waste, except as required by local regulations.
  • Collect and store dry dental amalgam waste in a designated airtight container. Amalgam designated for recycling should be labeled “Scrap Dental Amalgam” with the office name, address, phone number and the date material was first collected in the container.

Who enforces the regulation?

The enforcement agency in most areas is the sanitation agency to which a dental facility pays its sewer bill. Many sanitation agencies will be regulating dental facilities for the first time; therefore, it may be awhile before they communicate with dental facilities about the new rule. Each agency will have to create its own database of dental facilities. Dental facilities can expect to receive notification letters informing them of the published regulation, requirements and compliance dates.

Sanitation agencies will determine the level of regulation, including fees and permits, for dental facilities in their service area.

What are the potential penalties for noncompliance?

Penalties will be determined by the individual sanitation agencies. The new federal rule does not mandate inspections or penalties.

What do I need to know before purchasing an amalgam separator?

The American Dental Association published a product evaluation and an article, “Practical Issues for Purchasing, Installing and Maintaining Dental Amalgam Separators,” in its summer 2012 issue of Professional Product Review. 

CDA has worked with PureLife Dental to help make complying with the new mandate easier and more affordable. With the confidence of CDA’s Endorsed Services, PureLife’s ECO II amalgam separator is available to members for only $99 per unit with a discounted one-year replacement cartridge and disposal service agreement. 

My practice is in a building with other dentists. We all share the vacuum system and the landlord is responsible for maintenance as well as paying for water and sewage. Who is responsible for installing the separator – the dentist tenants or the landlord?

Inform the landlord of the new amalgam separator requirement and review your lease agreement. The lease agreement terms may determine who is ultimately responsible for installing amalgam separator equipment. The tenants and landlord also should discuss the situation with the local sanitation agency so the agency can determine who it will hold responsible for the required documentation.

Why has dental amalgam become a wastewater issue?

Dental amalgam contains mercury, and mercury is identified as one of 12 “persistent, bioaccumulative and toxic” chemicals targeted by local, state and federal environmental regulators. Under certain conditions, some forms of mercury can be transformed by a biological process to become the more highly toxic methylmercury and bioaccumulate in fish. Mercury is a naturally occurring element that cannot be destroyed, but can change forms.

With the enactment of various environmental and occupational safety regulations, the use of mercury by U.S. industries began a steep decrease in the mid-1980s. As industries eliminated mercury from some products, such as paints and pesticides, or reduced its use in batteries, lamps and electrical switches, environmental regulators turned their attention to 

mercury’s use in health care. Thermometers, blood pressure cuffs, medicines and dental amalgam are among the health care products that regulators have identified as sources of mercury that can be released into the environment. It should be noted that dentistry’s use of amalgam has decreased in the past two decades with a lower caries rate and with the popularity of tooth-colored restorative materials. The EPA and state and local environmental agencies measure and regulate for “total mercury.”

The EPA expects compliance with the 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 wastewater treatment plants (sometimes referred to as publicly owned treatment works, POTW). The estimated annual nationwide POTW discharge of dental mercury to surface water is expected to decrease from 1,003 pounds to 11 pounds.

What is the fate of dental amalgam once it enters a dental office’s plumbing lines and the community’s sewer system?

During placement or removal of amalgam restorations, most amalgam debris is caught by the chairside filter and by a secondary filter at the vacuum. Amalgam particulate is heavy, and research indicates that most of the particulate in

a wastewater stream will be entrained in amalgam-capturing devices or settle in pipes over time. If amalgam particulate makes it to a wastewater treatment plant, it is likely to be captured in one or more sediment or grit chambers at the plant. The resulting sludge (also called “biosolids”) may be disposed at a landfill, used as a soil amendment or incinerated. Sludge is regulated for mercury content. How much mercury is released from dental amalgam into wastewater is unknown, and the process is likely dependent on a variety of factors. Research indicates that some line cleaners, primarily those with oxidizers, may release mercury from amalgam.

What did the EPA consider when they drafted the rule?

Dental amalgam in wastewater has been a concern for environmental regulators for more than 20 years. Amalgam separator requirements have been implemented in various jurisdictions nationwide over those two decades, largely in areas where mercury in lakes and bays is a concern – San Francisco Bay Area, Seattle area and Great Lakes region, for example.

It allowed the treatment plants in those areas to study the impact of the separators, which is significant enough to consider a nationwide amalgam separator requirement. Sanitation agencies also studied other sources of mercury to wastewater treatment plants and concluded that dental facilities are a large source. The ADA confirmed that finding in a separate study in 2005 that estimated that dental offices contributed 50 percent of the mercury entering wastewater treatment plants. While dental facilities are a large source of mercury to wastewater, environmental regulators recognize that they are not a major contributor of mercury to the environment in general.

The EPA agreed it was easier, more efficient and less expensive to capture the dental amalgam before the material left the facility than to try to capture it once it entered the sanitary sewer system. The EPA also considered the addition of a requirement for “polishing,” a method involving ion exchange to remove dissolved mercury from wastewater. Although some amalgam separator manufacturers are considering the addition of the process to the equipment, the EPA chose not to require it for several reasons, including the lack of sufficient data on performance and that the technology is likely unavailable for many dental facilities due to inadequate space.

The EPA examined the characteristics of the dental industry and recognized that both the volume of wastewater discharged and the quantity of pollutants in the discharge on a per facility basis are significantly less than other industries for which the EPA has established “categorical pretreatment standards.” The EPA chose to exempt dental facilities from the oversight and reporting requirements associated with categorical pretreatment standards and, instead, established a performance-based standard.

How does the final rule differ from the 2014 proposed rule?

The requirements for dentistry in the 2014 rule are similar to what they are in the final rule. The significant difference between the two versions is the regulatory structure. The 2014 rule had more administrative requirements for dental facilities and required local agencies to implement a stringent program of inspections and penalties that would have increased resource needs for sanitation agencies and, likely, regulatory fees for dental facilities. CDA and the ADA advocated to the EPA for revisions to the proposed rule, published in 2014, with CDA calling for withdrawal of the rule to allow sanitation agencies, states and regions to “develop their own guidelines to use when developing and enforcing dental amalgam programs, which will allow for the appropriate response based on each local jurisdiction’s needs.” The final rule does not mandate inspections and allows sanitation agencies flexibility in enforcement.