Dental amalgam separator rule: what EPA requires, and the June 14, 2027 date

Who the rule covers

40 CFR Part 441 applies to "dental dischargers": a facility where dentistry is practiced "that discharges wastewater to a publicly owned treatment works (POTW)." It does not apply to offices that exclusively practice "Oral pathology, oral and maxillofacial radiology, oral and maxillofacial surgery, orthodontics, periodontics, or prosthodontics," to mobile units, or to offices that don't discharge amalgam process wastewater to a POTW.

Offices that "do not place dental amalgam, and do not remove amalgam except in limited emergency or unplanned, unanticipated circumstances" certify that to the Control Authority and are exempt from the rest of the rule.

The separator requirements

For offices the rule covers, 40 CFR 441.30(a)(1) requires a separator that meets ANSI/ADA Specification 108 or ISO 11143 and is "sized to accommodate the maximum discharge rate of amalgam process wastewater." Day to day, that means:

• Inspect: "in accordance with the manufacturer's operating manual"
• Fix a failure: repair or replace "as soon as possible, but no later than 10 business days after the malfunction is discovered"
• Swap the cartridge: per the manufacturer's schedule "or when the amalgam retaining unit has reached the maximum level," "whichever comes first"

The June 14, 2027 date

441.30(a)(1)(iii): a separator "installed at a dental facility prior to June 14, 2017" satisfies the standard and sizing requirements "until the existing separator is replaced as described in paragraph (a)(1)(v) of this section or until June 14, 2027, whichever is sooner."

After that date, the separator in use has to meet 441.30(a)(1)(i) and (ii). A pre-2017 unit that already meets them may not need replacing, so check with your Control Authority.

Two best management practices

40 CFR 441.30(b):

• Waste amalgam, including amalgam "from chair-side traps, screens, vacuum pump filters, dental tools, cuspidors, or collection devices, must not be discharged to a POTW."
• Lines that discharge amalgam process wastewater "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."

Paperwork

Two kinds of records:

• One-Time Compliance Report. Existing offices had to file it "no later than October 12, 2020, or 90 days after a transfer of ownership." A new owner files a new report "no later than 90 days after the transfer." Keep it for as long as the office operates or until ownership changes.
• Records kept "for a minimum of three years": each separator inspection (date, who, results, follow-up), cartridge replacements, "all dates that collected dental amalgam is picked up or shipped for proper disposal" with the name of the receiving facility, and any repair or replacement. Also keep "the manufacturers operating manual for the current device."

Who to send it to

EPA says "Your Control Authority is either a local wastewater utility, a state environmental agency, or a U.S. EPA regional office." For most states, EPA says to contact your EPA regional office, local wastewater utility or state pretreatment coordinator to find out which one is yours. EPA: Dental effluent guidelines.

What to ask a waste provider

Separator cartridges and amalgam scrap are a separate stream from red-bag waste. Ask whether the provider accepts them, who supplies the shipping paperwork, and which permitted or licensed facility receives them. That facility's name goes in your records. See Dental office medical waste disposal for the full list of dental streams.

What this page does not decide

This guide does not determine whether your office is covered, certify a separator, or file a report. Your Control Authority may use its own form and add local requirements.

Do older amalgam separators need to be replaced by 2027?

Not necessarily. A separator installed before June 14, 2017 meets the standard "until the existing separator is replaced as described in paragraph (a)(1)(v) of this section or until June 14, 2027, whichever is sooner." After that date, the separator in use has to meet 441.30(a)(1)(i) and (ii). A pre-2017 unit that already meets them may not need replacing, so check with your Control Authority.

How fast must a broken separator be fixed?

"as soon as possible, but no later than 10 business days after the malfunction is discovered," per 40 CFR 441.30.

How long do you keep amalgam separator records?

"for a minimum of three years," per 40 CFR 441.50(b). The One-Time Compliance Report is kept for as long as the office operates or until ownership is transferred.

Are orthodontists and oral surgeons covered?

No, if they practice exclusively in a listed specialty. The rule "does not apply to dental dischargers that exclusively practice" oral pathology, oral and maxillofacial radiology, oral and maxillofacial surgery, orthodontics, periodontics, or prosthodontics.

This page is run by MedSafeWaste.