EPA Amalgam Rule Regulations

Open4BioClean has developed this overview, including related links, of the EPA Amalgam Separator Rule, formally known as "Effluent Limitations Guidelines and Standards for the Dental Category", as an objective information resource for the dental industry.  Please look to end of this article to find the useful links that we have tested to be safe!

The Environmental Protection Agency (EPA) has published its final rule for technology-based pre-treatment standards under the Clean Water Act. This new rule, coined the "EPA Amalgam Separator Rule", is intended to reduce discharges of amalgam mercury generated by dental offices into municipal sewage treatment plants known as Publicly Owned Treatment Works (POTWs).

EPA Final Amalgam Separator Rule: This link opens the Federal Register, where the only 100% dependable information on 40 CFR Part 441 can be found: Effluent Limitations Guidelines and Standards for the Dental Category ==>

Effective date: July 14th, 2017 : Compliance date: July 14th, 2020

Amalgam Rule: Background: According to the 2002 Mercury Source Control and Pollution Prevention Program prepared by NACWA, dental offices who work with dental amalgam / mercury (removals and restorations of silver fillings) are the main source of mercury discharges to POTWs in the United States.

In December 2008, the EPA signed a MOU with the ADA and NACWA to establish and monitor the effectiveness of the Voluntary Dental Amalgam Discharge Reduction Program implemented in 2004. The EPA Amalgam Rule that is in place today was proposed in October 2014 after recognition that the voluntary program had failed.

A jointly funded study by the EPA and ADA concluded that a Pre-Treatment program, including installed amalgam separators, appropriate operations and record keeping, would result in a significant reduction of mercury discharged to POTWs.

The ADA believes that the regulations represent a fair and reasonable approach to the issue, according to President Gary Roberts, DDS. "We believe this new rule -- which is a federal standard -- is preferable to a patchwork of rules and regulations across various states and localities," Dr. Roberts stated in a press release.

Amalgam Rule: Overview: The EPA Amalgam Separator Rule requires dental offices (a) install an ISO compliant amalgam separators; (b) operate the separator in accordance with the manufacturers manual and follow two BMPs ( i) use evac cleaners with pH between 6 and 8. (ii) no amalgam waste discharged to POTWs; and keep accurate records of compliance.

Amalgam Rule: Applicability: The EPA Amalgam Separator Rule is applicable to all Dental Dischargers. A Dental Discharger is defined as a facility where the practice of dentistry is performed, including, but not limited to, institutions, permanent or temporary offices, clinics, home offices, and facilities owned and operated by Federal, state or local governments, that discharges wastewater to a publicly owned treatment works (POTW).

The EPA Amalgam Separator Rule does not apply to the following Dental Dischargers.

i) to Dental Dischargers that exclusively practice one or more of the following dental specialties: oral pathology, oral and maxillofacial radiology, oral and maxillofacial surgery, orthodontics, periodontics, or prosthodontics.
ii) to wastewater discharges from a mobile unit operated by a Dental Discharger.
iii) to Dental Dischargers that do not discharge any amalgam process wastewater to a POTW, such as Dental Dischargers that collect all process wastewater in an  Anterior Quest containment system for transfer to a Centralized Treatment facility.

Amalgam Rule: Pretreatment: The EPA Amalgam Separator Rule requires all applicable Dental Dischargers to remove dental amalgam solids from ALL amalgam process wastewater by installation, operation, and maintenance of one or more amalgam separators, or amalgam removal device(s) that meet the following requirements.

- achieve at least a 95% removal efficiency.
- sized to accommodate the maximum discharge rate of amalgam process wastewater.
- inspected in accordance with the manufacturer’s operating manual to ensure proper operation and maintenance.
- retaining units (containers) replaced in accordance with the manufacturer’s schedule and operating manual.

EPA is not proposing to establish pre-treatment standards based on technologies that remove dissolved mercury, or polishing. EPA has inadequate data to truly assess the efficacy of polishing or its general availability for nationwide use.

Amalgam Rule: BMPs: The EPA Amalgam Separator Rule requires all applicable Dental Dischargers to implement the following two Best Management Practices (BMPs).

i) 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.

ii) 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 6 or greater than 8.

Amalgam Rule: Record Keeping : The EPA Amalgam Separator Rule requires the following records to be kept:

i) existing Dental Dischargers to provide a one time Compliance Report to their Control Authority no later than 3 years and 90 days from the rule Effective Date, or 90 days from transfer of ownership.

ii) new sources to provide a one time Compliance Report to their Control Authority no later than 90 following the introduction of wastewater into a POTW.

iii) to maintain for inspection, in either physical or electronic form, for a minimum of 3 years, the following documentation.

- date, person(s) conducting the amalgam separator inspection.
- amalgam retaining container (or equivalent) replacement, including the date.
- dates that collected dental amalgam is sent 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.
- 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).

Amalgam Rule: Existing regulations: Thirteen states have implemented mandatory programs to reduce dental mercury discharges. Including Connecticut, Louisiana, Maine, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Oregon, Rhode Island, Vermont, Washington and New Mexico. In addition 19 localities have legislated amalgam reduction pre-treatment programs.

Amalgam Rule: Legal authority: The EPA has published this Rule under the authorities of the Clean Water Act CWA and pursuant to the Pollution Prevention Act of 1990, 42 U.S.C. 13101 et seq.

Amalgam Rule: Contact: Mr Damon Highsmith, Engineering and Analysis Division (4303T), Office of Water, Environmental Protection Agency; telephone: 202-566-2504; email: [email protected].

Amalgam Rule Regulatory process: June 9th 2017: The Acting Assistant Administrator for Water, Michael Shapiro, signed the final  rule  on June 9, 2017, and EPA is submitting it for publication in the Federal Register.

February 1st, 2017: The Natural Resources Defense Council (press release) sues the EPA (Case: 17-cv-751) for illegally rescinding a rule that would protect the public from more than five tons of mercury discharges each year.

January 20th, 2017: EPA withdraws the final "amalgam separator rule" from publication, and the Office of the Federal Register acquiesced in that withdrawal request, in response to a memorandum issued by the White House to all federal executive agencies late in the day on Friday, January 20, 2017, shortly after President Trump was inaugurated.

December 15th, 2016: Gina McCarthy, signs the "amalgam separator rule", and delivers it to the Office of the Federal Register for publication. The Office of the Federal Register posted the final "amalgam separator rule" for public inspection on or before Thursday, January 19, 2017, and scheduled it for publication in the Federal Register.

Amalgam Rule: Justification: The EPA estimates that 31.4 tons of mercury is generated by dental restorations and dental extractions each year. A portion of this is captured by all dental offices in existing chair side traps and vacuum pump filters. A further portion is captured by existing amalgam separators in the 13 regulated states, and 20 regulated territories. Leaving an estimated 8.8 tons of metals discharged POTWs each year. Approximately 4.4 tons of the metal discharged is mercury.

The POTWs capture 90% of the mercury. The remaining 10% is released into the surface waters around the plants. A 2002 study by the New York Academy of Sciences concluded that 40% of the mercury in their local waterways originated in dental offices. The data published by Kings County showing change in mercury levels after their implementation of a pre-treatment rule for the circa 1000 dental offices located in their sanitary district supports this conclusion.

Amalgam Rule: Public comment: "The ADA believes the Environmental Protection Agency's new federal regulation represents a fair and reasonable approach to the management of dental amalgam waste," said Dr. Gary L. Roberts, ADA president, in a statement. "We believe this new rule, which is a federal standard, is preferable to a patchwork of rules and regulations across various states and localities."

Amalgam Rule: Useful links: The following links have been tested to be accurae and virus free!

i) EPA Web site: Dental Effluent Guidelines ==>
ii) EPA Web site: Pretreatment Program Contacts ==>
iii) Federal Register: 40 CFR Part 441 ==>
iv) MMC Health: Free electronic reporting ==>
v) Regulations.gov: Proposed pre-treatment rule ==>

Editorial opinion

The EPA calculation assumes that 100% of dentists in the regulated areas for amalgam separation have complied. It further assumes that 20% of dentists in unregulated areas have voluntarily installed amalgam separators. In practice New York estimates that 35% of dentists have not complied. Michigan estimates that 40% of dentists have not complied, adding "proof of compliance" as a requirement for dentists to renew their license. Our research indicates that 2% of dentists have voluntarily installed amalgam separators.

Everyone agrees that mercury is a persistent and bio accumulative pollutant with well-documented effects on human health. The U.S.A dental industry is not a significant contributor to global mercury poisoning. But the American dental industry is responsible for 40% of mercury found in American public water. When it was proven that 6 years of a voluntary program had failed, the EPA, the ADA and other authorities were forced to regulate this issue.

I understand why dentists have been reluctant to accept the cost of capturing amalgam-mercury removed from patients mouths. Many do not use amalgam-mercury and they did not create this issue. Why should they pay to resolve this? It is what happens when societies avoid accountability for the long term environmental costs of their products lifecycle.

I sincerely hope that offices will review our article titled, are you using too many chemicals in your dental practise as they consider microbial cleaners as an alternative to chemical cleaners. In particular finding cleaners that do not soluabilize the mercury collected in their separators. That meet the required standard of, no 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.

I am grateful to the dedicated staff at the EPA. To the ADA for holding to their commitment to support a simplified regulation. To the POTWs who have a practical platform to determine what is appropriate to their environmental needs.

We trust that this long standing issue in the dental industry finally being resolved.

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