As of July 14, 2020, sources subject to the Amalgam Separator Rule must comply.
The amalgam recycling rule is an implementation of the Clean Water Act and was in effect as of July 14, 2017. It is designed to reduce the discharge of amalgam waste from dental offices into the municipal sewage. If you practice in a state or municipality that already has an amalgam separator rule that’s not quite the same as this federal rule, they may have reporting requirements that differ so you may need to continue those reporting obligations. However, the state or municipality (which handle the administration of this federal rule) may decide to conform their requirements to this federal rule and EPA has encouraged this approach, but not mandated it. The entire rule may be read here.
The rule mandates that most dental offices install, maintain, and monitor an amalgam separator that complies with 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). You may continue to operate an already installed amalgam separator for its lifetime or ten years (whichever comes first), as long as you comply with the other rule requirements including the specified Best Management Practices (BMP), operation and maintenance, reporting, and record-keeping requirements. Newly purchased or built offices must comply within 90 days of taking ownership.
Dental offices must also submit a compliance report. Additionally they will need to have maintenance and inspection records available.
Disclaimer: These materials are intended to provide helpful information to dentists and dental team members. They are in no way a substitute for actual professional advice based upon your unique facts and circumstances. This content is not intended or offered, nor should it be taken, as legal or other professional advice. You should always consult with your own professional advisors (e.g. attorney, accountant, insurance carrier). To the extent ADA has included links to any third party web site(s), ADA intends no endorsement of their content and implies no affiliation with the organizations that provide their content. Further, ADA makes no representations or warranties about the information provided on those sites.
Who must comply?
Most practicing dentists who discharge wastewater into a publicly owned treatment work (POTW), such as a municipal sewer system, must comply. Exemptions are as follows:
- Dentists who exclusively practice one or more of the following dental specialties: oral pathology, oral and maxillofacial radiology, oral and maxillofacial surgery, orthodontics, periodontics, or prosthodontics.
- Mobile dental units.
- Dentists on septic systems.
- Exempt from installing a separator, but must file a one-time compliance report:
- Dentists who do not place amalgam and only remove amalgam in unplanned or emergency situations (EPA equates this with less than 5% of procedures including amalgam removal).
When does it take effect?
The rule goes into effect July 14, 2017
The compliance date, meaning the date that sources subject to the rule must comply with the standards in this rule, is July 14, 2020.
Newly opened offices are subject to the rule almost immediately, as they must comply by July 14. 2017.
Those already equipped with separators: Old separator satisfies the new rule until ten years from issuance of rule (June 14, 2027) or until the old separator is replaced, whichever comes first.
Does the EPA's amalgam separator rule apply to dentists on septic systems?
No. The final rule does not apply to dental discharges to septic systems.
What are the specifications for an acceptable amalgam separator?
What is the required paperwork?
One-Time Compliance Report: Note that a copy of this report must be retained by the practice and made available for inspection for the lifetime of ownership of the practice. See below for instructions on how to find report and mailing addresses.
- For most exempt sources, this report is not required. For those claiming exemption because they do not place or remove amalgams, this report is due October 12, 2020
- For existing sources that must comply, due October 12, 2020 or 90 days after transfer of ownership.
- For new offices, 90 days after the first emission of wastewater into the public system.
- For those who neither place nor remove (with limited exceptions) amalgam, the one-time compliance report must include the:
- facility name,
- physical address,
- mailing address,
- contact information,
- name of the operator(s) and owner(s);
- a certification statement that the dental discharger does not place dental amalgam and does not remove amalgam except in limited circumstances
- signature of the responsible corporate officer, general partner or proprietor or a duly authorized representative of the responsible corporate officer, general partner or proprietor
- For those subject to the rule, the one-time report must include:
- The facility name, physical address, mailing address, and contact information.
- 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, and 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.
- Certification that the amalgam separator(s) or equivalent device is designed and will be operated and maintained to meet the requirements
- Certification that the dental discharger is implementing BMPs specified 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.
- Signature of the responsible corporate officer, general partner or proprietor or a duly authorized representative of the responsible corporate officer, general partner or proprietor.
- Three-year record retention requirement (note that the One-Time Compliance Report must be retained for the duration of ownership of the practice):
- 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).
- Dischargers or an agent or representative of the dental discharger must maintain and make available for inspection in either physical or electronic form the manufacturers operating manual for the current device.
Where do I find the one-time compliance report that I am to fill out and submit?
The link below takes you to a sample compliance report provided by the EPA. Note: Your Control Authority may have a different form. Please contact your Control Authority to determine which form to use.
Where should I send my one-time compliance report? Who is my "Control Authority?"
Your Control Authority is either a local wastewater utility, a state environmental agency, or a U.S. EPA regional office.
Dental offices in Alabama, Connecticut, Mississippi, Nebraska or Vermont
Your Control Authority is your state agency.
• State Agency Contacts
Dental offices in all other states
Contact your EPA regional office, your local wastewater utility, or your state agency Pretreatment Coordinator to find out who your Control Authority is.
• Pretreatment Program Contacts
Is there a website where I can submit my one-time compliance report electronically?
Check with your local Control Authority to see if this an option for you. U.S. EPA did not create a website for dentists to submit their one-time compliance report.
What are the in-office procedures I must follow?
- Monitor and maintain the unit according to the manufacturer’s recommendations.
Inspect at least once per month to ensure proper operation and maintenance of the separator, including confirmation that amalgam process wastewater is flowing through the retaining cartridge, separator canister, or amalgam separating portion of the amalgam separator (preventing bypass).
- Replace or repair the unit within 10 business days if any malfunction is detected.
Maintain the unit by replacing the amalgam retaining cartridge(s), separator canister(s), or separator unit(s) as specified by the manufacturer’s operating manual or whenever the collection of retained solids reaches the manufacturer’s stated design capacity, whichever comes first.
- No discharge of waste amalgam including, but not limited to, dental amalgam from chair-side traps, screens, vacuum pump filters, dental tools, cuspidors, or collection devices, to a publicly owned treatment work (a POTW, otherwise known as a municipal sewage treatment plant). In short, this means no flushing waste down the drain.
- No cleaning or flushing of dental unit water lines, chair-side traps, and vacuum lines with oxidizing or acidic cleaners, including but not limited to bleach, chlorine, iodine and peroxide that have a pH lower than 6 or greater than 8.
- Install the separator unit such that it:
- receives all amalgam process wastewater
is sized to incorporate all wastewater that may pass through it
Does the ADA have a list of compliant amalgam separator manufacturers?
No, the ADA does not maintain a list of compliant units or manufacturers.
ADA Business Resources does have an endorsed relationship with HealthFirst that gives members a 33% discount on an amalgam recovery system that is compliant with this regulation. Read more here.
What happens if I already have an amalgam separator in place?
Existing separators are deemed to be in compliance for ten years from the issuance of the rule (meaning June 14, 2027) or until replaced, whichever is sooner. Offices with existing separators must still comply with the other rule requirements including reporting, maintenance and recordkeeping.
What about state and local requirements that are different than what I read here?
The EPA rule is a floor, not a ceiling, for regulating dental office wastewater. The Control Authority may expedite EPA compliance deadlines, require additional information in the one-time compliance report, and impose other requirements that go beyond those in the EPA rule.
What did the ADA do during the rulemaking process to help make it easier for dentists?