EPA's final rule on amalgam separators expected soon

The Environmental Protection Agency in October 2014 issued a draft rule under the Clean Water Act to control the discharge of mercury and other metals entering the waste stream from dental practices. The final rule, which may become effective as early as December 2016, will regulate dental practices that place or remove amalgam. The rule is not intended to apply to dental practices that do not place or remove amalgam, such as orthodontic and periodontic practices, except in limited emergency circumstances.

Under the proposed rule, a dental practice that places or removes amalgam will be subject to two best management practices (BMPs): 1) collect and recycle scrap amalgam; 2) clean the chairside traps with non-bleach or non-chlorine cleanser so as not to release mercury. 

There is also an amalgam separator requirement. A dental practice must meet a 2008 ISO 11143 certified amalgam separator standard to achieve 99 percent or greater mercury removal efficiency.  It is proposed that dental practices with existing amalgam separators achieving at least 95 percent efficiency with a remaining useful life be required to replace the equipment and meet the new amalgam separator requirement 10 years from the effective date of the final rule.

Additionally, under an annual reporting requirement, dental practices must submit to the local authority a certification statement that BMPs are being followed and the amalgam separator is being maintained.

The proposed rule requires dental practices to meet certain regulatory deadlines. These dates may change under the final rule:

  • Submit a baseline report and schedule within 180 days after the effective date of the rule;
  • Submit a compliance report no later than 90 days after the compliance date (three years from the effective date of the rule) that certifies BMPs are being followed and the amalgam separator has been installed and maintained.

Once the final rule has been published, affected dental practices should receive communication from their local sanitation agency with specific details about the reports, schedules and pretreatment standards and with any changes in the proposed requirements outlined here.

As reported previously on cda.org and in the CDA Update, both CDA and the ADA advocated to the EPA for revisions to the proposed rule, with CDA calling for withdrawal of the rule to allow POTWs, states and regions to “develop their own guidelines to use when developing and enforcing dental amalgam programs which will allow for the appropriate response based on each local jurisdiction’s needs.”

CDA is developing an FAQ and other resources to assist dental practices with compliance. The FAQ will address compliance dates, California-specific required BMPs, penalties for noncompliance and more. CDA will also provide a special offering on an amalgam separator through CDA Endorsed Programs. Watch for more information on cda.org and in the CDA Update.

Related Items

The California EPA’s Office of Environmental Health Hazard Assessment has adopted a regulation revising the notices that dental practices are required to post under Proposition 65, known as the Safe Drinking Water and Toxic Enforcement Act. The regulation takes effect in 2018.

Now, in one handy place, CDA members can find the details, deadlines and resources they need to ensure their dental practice is in compliance with upcoming laws and regulations. On the main Practice Support webpage, the new “Are You in Compliance” section lists laws and regulations that dental practices will need to comply with.