Complying with the EPA Amalgam Separator Rule in These Challenging Economic Times

  • by Alfred L. Frost III, MS, DDS, MBA
  • Jun 15, 2020

Nearly two months of mandatory office closures, except for treating the occasional emergency, has proved an extreme hardship for both patients and dentists. Finally, some pandemic restrictions have been lifted, and patients can seek the care they require, but you have missed out on two months of revenue while still having to pay many overhead costs.

With general dental practices, which usually operate with between 55% and 72% in overhead costs, critical emphasis must now be placed on reducing capital expenditures as well as regular operating costs in order to reestablish positive cash flows and the overall financial health of the practice. The need for cost containment should be on every dentist’s mind — while we are first and foremost healthcare professionals, we are also small business owners. 

This problem of stretched dental practice budgets is one that the federal EPA had chosen not to recognize. Under the new amalgam separator rule, dentists must install an amalgam separator and begin recycling amalgam waste by July 14. Under the rule, any office that either places or removes amalgam must comply.

Exempt from compliance are offices that exclusively practice oral and maxillofacial pathology, surgery or radiology as well as orthodontics, periodontics or prosthodontics. Mobile dental units are also exempt. The only other exception is made for practices that place or remove amalgam restorations only on extremely rare occasions. If you are in this category, you will need to file a signed certification to that effect. I have spoken with pediatric dentists who believe they always fall in this category. If you remove only a few old amalgams per month, that IS NOT considered a rare occasion. I say this so you don’t place your practice in violation through a misinterpretation of the rule. At the end of the day, this rule applies primarily to general and pediatric dentists and to endodontists.

ADA-established best management practices (BMPs) must be adhered to, according to the rule. These include four key items:

  1. Only pre-capsulated alloy may be used. You may not have “raw” elemental mercury in the office except in pre-capsulated form.
  2. Line cleaners must be in a tight pH range and be neither less than 6 nor greater than 8.
  3. Amalgam separators must be installed and maintained and their contents properly recycled.
  4. Scrap amalgam (excess mix and carvings, empty capsules from pre-capsulated alloy, extracted teeth containing amalgam, in-line disposable traps and vacuum traps from wet vac units) must be collected and sent for recycling. This owes to the fact that, on average, 70% of amalgam waste is in this form. The remaining 30% is fine particulate captured in the amalgam separator.

Amalgam separators must be either ISO 11143- or ANSI/ADA 108-2009 certified. Certification from other testing laboratories is not acceptable. Separators must have an efficiency rating of 95%. They must be inspected and maintained and have their collecting canisters recycled per manufacturer guidelines. Further, they must be sized to accommodate the maximum discharge rate of wastewater passing through them and be configured to receive all amalgam containing wastewater without the possibility of a bypass.

Concerning reporting and recordkeeping, a one-time compliance report (OTCR) must be filed by Oct. 12, 2020. 

This OTCR must include a signed certification, the facility name, the physical address, the mailing address and the contact information for both the facility owner and the facility operator. The certification must include:

  1. Total number of chairs.
  2. Total number of chairs in which amalgam may be present in the wastewater.
  3. A description of any existing separator (including make, model and year of installation).
  4. Certification that the separator meets all EPA standards for design, operation and maintenance.
  5. Certification that the facility has implemented and will continue to use all BMPs.
  6. The name of the third-party provider who maintains the separator.

If the practice only places or removes amalgam in very rare instances (as previously described), an additional signed and certified statement to that effect must be included with the OTCR.

The OTCR must be retained for as long as the practice is in business. Additionally, the following must be maintained for a period of at least three years:

  1. Date of separator inspection, name of person conducting inspection, results of inspection and summary of follow-up actions.
  2. Dates of separator (canister) changes/replacements.
  3. Date waste is picked up or shipped for recycling and the name of the licensed treatment, storage and disposal facility receiving the waste canister.
  4. Documentation of any repairs or replacements (mechanical), dates of repair or replacement, name of person performing service, description of service including make and model of separator.
  5. A copy of the manufacturer’s operating manual.

In a time when most offices are struggling with reopening obstacles such as reduced cash flow, potential shortages of PPE and the increasing cost of it, retraining staff in social distancing and other COVID prevention measures, reduced seating in reception areas, etc., the last thing you need is to purchase an amalgam separator, for which prices often start at $850.

While the EPA may not care, AGD does. AGD has vetted and chosen to partner with Dental Recycling North America Inc. (DRNA), the No. 1 direct-to-dentist company in the United States whose sole business is amalgam separators and recycling. Under the agreement, AGD members are eligible for an amalgam separator at NO COST with a signed three- to five-year service contract.1 This allows you to become fully compliant without the need to expend valuable cash reserves at this difficult time.

If you’re saying to yourself, “Nothing is ever free. What’s the catch?” — allow me to explain. As DRNA deals directly with dentists, not middlemen, we operate at lower costs, which we pass on to customers. In these extraordinary times, we will give you the first separator for free. Under the EPA Rule, these separators must be recycled. Ours is recycled once per year, which also makes it complaint with OSHA guidelines regarding maximum storage time for wastes in an office. At the end of each year in service, the separator is returned to us for processing, and a new one is sent. Our annual fee for the new unit, shipping both ways, recycling contents, production of documentation for you, etc., is only $500. 

When you sign up with DRNA, your first unit is free. You will not pay anything until that unit has been in place for one year and we ship you the replacement. This means you have no fees of any kind until after a full year has passed, giving you time to get your practice back to the success it was before the closures.

We know that you will have to recycle this waste for years to come. For this reason, we have also reached an agreement with AGD not to raise our annual recycling fee for five years. 

We know this has been a difficult time for dentists, and we want you to know that AGD has gone over and above to help you eliminate the cost of complying with this new regulation. We at DRNA are honored to be AGD’s endorsed vendor. Call us today at 800.360.1001, ext. 2, to sign up for your free amalgam separator benefit. Learn more about DRNA.

1. Receive a free unit when you sign a three- or five-year recycling agreement at $500 per year for the BU10 (1–8 chairs) and $750 per year for the BU30 (9–16 chairs).

Alfred L. Frost III, MS, DDS, MBA, is vice president for clinical and scientific affairs at Dental Recycling North America Inc.