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

Open4BioClean has published an analysis 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.

EPA Amalgam Separator Rule: Latest status: June 14th, 2017: The EPA Final Amalgam Separator Rule, Effluent Limitations Guidelines and Standards for the Dental Category, is published by the Federal register.

EPA Amalgam Separator Rule: Effective date: July 14th, 2017

EPA Amalgam Separator Rule: Compliance date: July 14th, 2020     

EPA Amalgam Separator Rule: Judicial Review: In accordance with 40 CFR part 23, this regulation shall be considered "issued for purposes of judicial review at 1 p.m. Eastern time on June 28, 2017".

Under section 509(b)(1) of the CWA, judicial review of this regulation can be had only by filing a petition for review in the U.S. Court of Appeals within 120 days after the regulation is considered issued for purposes of judicial review. Under section 509(b)(2), the requirements in this regulation may not be challenged later in civil or criminal proceedings brought by EPA to enforce these requirements.

Regulatory certainty begins: October 26th, 2017

Background: According to the 2002 Mercury Source Control and Pollution Prevention Program prepared by NACWA, dental offices, which discharge mercury in amalgam used (removals and restorations) for fillings, are the main source of mercury discharges to POTWs in the United States.

A jointly funded study by the EPA and ADA concluded that amalgam pre-treatment and BMPs by dental offices would result in a significant reduction of mercury discharged to POTWs. In December 2008, the EPA signed a MOU with the ADA and NACWA to establish and monitor the effectiveness of the the Voluntary Dental Amalgam Discharge Reduction Program implemented in 2004. The rule was proposed in October 2014, after recognition that the voluntary program had failed.

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.

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.

Overview: The Amalgam Separator Rule requires dental offices to use amalgam separators and follow two BMPs recommended by the ADA. i) use evac cleaners with pH between 6 and 8. ii) no amalgam waste discharged to POTWs.

Applicability: The 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 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.

Pretreatment amalgam solids: The 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.

Pretreatment BMPs: The 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.

Reporting and recordkeeping: The Amalgam Separator Rule requires:

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).

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.

Legal authority: EPA is proposing this regulation 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.

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

Amount of mercury: 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.

ADA 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."

Links: The following links have been tested to be accurate, virus and scam free!

i) EPA Final Amalgam Separator Rule: Effluent Limitations Guidelines and Standards for the Dental Category
ii) EPA Web site: Dental Effluent Limitations
iii) Proposed rule: Effluent Limitations Guidelines and Standards for the Dental Category
iv) Docket No. EPA-HQ-OW-2014-0693: Government Printing Office's FDsys website
v) Office of Management and Budget: Rule - Reginfo.gov
vi) Soluble mercury report by Purves Environmental, Inc

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 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.

The following is a statement by Margaret Hsieh, attorney on the Litigation team at NRDC: who stepped in to persuade the EPA to complete the regulatory process, which stalled at the incoming administration on 20th January.

“EPA is taking an important step towards safeguarding Americans from a dangerous neurotoxin.  The agency decided to reissue the rule, instead of defending in court the decision to withdraw it.  Protecting the public—and not responding to a lawsuit—should have been motivation enough for this sensible action.”

We look forward with hope to this long standing issue in the dental industry finally being resolved.

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