EPA issues final rule: Amalgam separators required

The administrator for the Environmental Protection Agency has signed off on a final rule under the Clean Water Act to control the discharge of mercury and other metals entering the waste stream from dental practices. The rule will regulate dental practices that place or remove amalgam — it is not intended to apply to dental practices such as orthodontic and periodontal practices except in limited emergency circumstances. The effective date of the rule is 30 days after the rule is published in the Federal Register. The compliance date for most dentists will likely be January 2020, three years after the effective date.

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

The rule also includes an amalgam separator requirement, stating that a dental facility must install an amalgam separator that is compliant with either the American National Standards Institute American National Standard/American Dental Association Specification 108 for Amalgam Separators (2009) with Technical Addendum (2011) or the International Organization for Standardization 11143 Standard (2008) or subsequent versions so long as that version requires amalgam separators to achieve at least a 95 percent removal efficiency.

CDA recommends that members not purchase separators until the rule is published.

Dental practices that already have amalgam separators will be required to replace the equipment within 10 years of the rule’s effective date with equipment meeting the new standard.

Additionally, there are reporting requirements. All dental facilities must submit to the local authority a compliance report and have maintenance and inspection records available for inspection.

CDA and the ADA advocated to the EPA for revisions to the proposed rule, published in 2014, with CDA calling for withdrawal of the rule to allow sanitation agencies, 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 dates, California-specific required BMPs, penalties for noncompliance and more. 

In addition, CDA has worked with PureLife Dental to help make complying with the new mandate easier and more affordable. With the confidence of CDA’s Endorsed Programs, PureLife’s ECO II amalgam separator is available to members for only $99 per unit with a discounted one-year replacement cartridge and disposal service agreement. To learn more, visit cda.org/amalgam.

Related Items

Dental practices that are required to comply with Section 1557 of the Affordable Care Act must complete and submit to the U.S. Department of Health and Human Services the Assurance of Compliance form. HHS 690 can be downloaded, completed and mailed or completed and submitted online.

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.