1



### Administration of the List of Approved Amalgam Separators

Metropolitan Council Environmental Services & Minnesota Dental Association



### August 24, 2004



## Introduction

The purpose of this document is to describe the procedure for adding an amalgam separato r to the List of Approved Separators that is part of the Voluntary Amalgam Recovery Program. This program is being jointly implemented by Metropolitan Council Environmental Services (MCES) and the Minnesota Dental Association (MDA). The List of Approved Se parators is administered by the Steering Committee, which is comprised of representatives from MCES and the MDA.



## Policy

In order to be included on the MCES/MDA Steering Committee’s list of approved amalgam separators:

New amalgam separator models must be tested according to the ISO 11143 Standard and obtain a laboratory test report and a certificate;

Amalgam separator models, whose collecting container has been modified in a manner that may reduce the removal efficiency of the unit, must be retested ac cording to ISO 11143 and obtain a laboratory test report

and a certificate;

Separators must remove at least 99% of the amalgam, as tested according to ISO 11143 (based on the average of the data for testing under empty and simulated full conditions).

The manufacturer/distributor of an amalgam separator on the Approved List must inform the MCES/MDA Steering Committee when any changes are made to their separators prior to marketing the modified separators. Lack of disclosure may expose the manufacturer to sa nctions as determined by the Steering Committee.

In the case of modifications to auxiliary components of an amalgam separator, for those models where the auxiliary components were part of the initial ISO 11143 testing, ISO 11143 retesting will not be requ ired if the following criteria are met:

The collecting container of the separator, which treats the wastewater, remains unchanged, and Modifications to any auxiliary component do not reduce the separator’s amalgam removal efficiency.

The addition or mod ification of an auxiliary component that may affect or regulate the flow (such as a “flow restrictor”) will not result in the need for ISO retesting. However, hydraulic testing will be required in order to verify that the flow does not exceed the flow cond itions present during ISO 11143 testing. (See Appendix A.) Examples of modifications that may affect the flow through a separator include (but are not limited to): addition of a flow restrictor, modification of a flow restrictor, changes to the volume or dimensions of a surge tank, and modifications of internal connections or plumbing within a separator.

This policy section notwithstanding, the Steering Committee may require ISO 11143 retesting if it has specific concerns about an amalgam separator or if its ability to perform at its originally tested removal efficiency is

uncertain.

File: Hg

- Amalg Rec Prog, Sep Model Review Criteria 8

- 04 (V

- drive, Reformatted March 16, 2005)2



## Issuance and Acceptance of Laboratory Test Reports and Certificates

Lab oratory test reports and certificates issued for the ISO 11143 Standard will be accepted only from testing labs and certification bodies approved and listed by the Steering Committee. Currently, those listed are RWTÜV (Germany) and SP Swedish National Test ing and Research Institute (Sweden). Additional testing laboratories and certification bodies may be added by the Steering Committee if these laboratories or certification bodies are each accredited and their scope of accreditation includes the ISO 11143 S tandard.



## Glossary

Accredited Certification Body : An organization that is accredited (e.g., by ANSI in the United States or SWEDAC in Sweden) to issue certificates.

Amalgam separator : The collecting container, any auxiliary component (e.g., surge tank), and internal connecting plumbing or fixtures between the collecting container and the auxiliary component(s).

Auxiliary component : A part of the amalgam separator that is not part of the collecting container, but is marketed as part of the separator. This does not include basic fittings added by a plumber for the purpose of installing the separator. (Plumbers are not to modify the inner workings of a separator.)

Certificate : A document issued by a “certification body” which confirms that the separator passe d all of the requirements of ISO 11143 and sets up a quality control system between the certification body and the separator manufacturer. A certificate assures continuity in the manufacturing of separators that conform to the requirements of the ISO Stand ard. A certificate is obtained in addition to the laboratory test report. The certificate must be issued by an accredited certification body (accredited by ANSI if located in the United States). See section above on Issuance and Acceptance of Laboratory Te st Reports and Certificates.

Collecting container : That part of the amalgam separator performing the treatment and removal of amalgam waste solids (and in some models, dissolved mercury) from the wastewater.

Flowrate : Rate at which wastewater passes thro ugh the amalgam separator for flow

- through models, or the rate at which the amalgam separator is decanted for batch

- treatment models (expressed in liters/minute or milliliters/minute).

Modified model : The model that is similar, and based on, the original m odel. In the modified model, the collecting container, or one or more of the auxiliary component(s) that were part of the ISO testing of the original model, have been altered.

Original model : That model that was tested according to ISO 11143 and approved a nd listed by the MCES/MDA Steering Committee.

Pressure head : The height of wastewater above the collecting container.

Settling time : The amount of time to treat the wastewater via settling.

Steering Committee : The committee comprised of representatives fro m MCES and the MDA that developed and oversee the implementation of the Voluntary Amalgam Recovery Program.



## Procedure

The steps to be taken by the manufacturer/distributor and the MCES/MDA Steering Committee are outlined

below and illustrated in a “Deci sion Tree”, see Appendix B, on page 7:

A. The amalgam separator manufacturer/distributor submits a request to add a new or a modified model to the MCES/MDA list of approved separators. The submittal should include all information necessary to complete the “F eatures” table shown in the “re: amalgam recovery” booklet and on the MDA website showing updated information. For new models, the submittal must include the test report and certificate.3

In the case of modified models, the manufacturer must also put toge ther a submittal addressing the following points:

1. State the name of the modified model.

2. Describe the nature and location of all modifications and how these modifications may affect the performance of the separator. The description of the modification loca tion shall specify if the modification was made to the collecting container or to the auxiliary components of the separator. Changes to the collecting container will trigger a requirement for retesting according to ISO 11143.

3. Describe any effect the change s will have on the pressure head, flowrate, the settling time, or any other performance factor of the modified model.

4. Explain any operational changes (operation & maintenance) that the dental clinic staff will have to implement to ensure that the modified model will perform at least as well as the original model.

5. Declare whether the model will achieve at least the same level of treatment (amalgam removal) as the original model and provide information (such as engineering or hydraulic information) to support this claim (see “Supporting Information” on page 3).

6. Give the specifications for the “Features” table and note any changes to the specifications as compared to the original model.

The required information shall be submitted to both Loren Hanson at the MD A and Peter Berglund at MCES. (See complete contact information on page 4.)

B. The MCES/MDA steering committee will review the information submitted by the manufacturer/distributor,

as described in Part A above. A determination will be made to either:

1. Appr ove the new, or modified, amalgam separator model;

2. Inform the manufacturer/distributor that an approval cannot be made, and allow the manufacturer/distributor an opportunity to submit additional information; or

3. Inform the manufacturer/distributor that an a pproval cannot be granted without the submittal of a test report and a certificate for ISO 11143 testing.



## Supporting Information

In the case of a manufacturer/distributor claiming that the modified separator model will perform at least as well

as their original model in terms of amalgam removal, it is up to the manufacturer/distributor to submit information to support their claim. The manufacturer/distributor is responsible for considering all factors that may affect the performance of their modified mod el. Independent testing may be required to verify the information and data submitted by the manufacturer/distributor.

The following are examples of types of engineering or other information that the manufacturer/distributor could submit as part of their s upporting documentation:

Dimensions of the separator model and any auxiliary components
Hydraulic test results with data on pressure, flowrate, or settling time. (See Appendix A.)4 

## Timeline

Within two weeks of receipt of a request, the steering commit tee will notify the manufacturer/distributor to confirm that the request has been received.

If additional information is required in order for the request to be evaluated, the steering committee will notify

the manufacturer/distributor within two months t o explain what additional information must be submitted.

Upon receipt of all necessary information, the steering committee will evaluate the request and within two

months either:

Approve the new or modified separator model and add it to the approved list , or Deny the request for addition to the list and inform the manufacturer/distributor of the reason for denial. The denial letter shall indicate that ISO 11143 testing and a certificate will be required prior to any further

consideration of the model for addition to the Approved List.



## Contact Information for the MCES/MDA Steering Committee

The points of contact for the MCES/MDA Steering Committee are:

Mr. Loren Hanson Mr. Peter Berglund, P.E.

Minnesota Dental Association Metropolitan Council En vironmental Services

2236 Marshall Avenue Industrial Waste & Pollution Prevention Section

Suite 200 230 East 5 th Street

St. Paul, MN 55104 St. Paul, MN 55101

651

- 646

- 7454 651

- 602

- 4708 lhanson@mndental.org peter.berglund@metc.state.mn .us

Unless directed otherwise, submittals to the Steering Committee should be made in duplicate, with one copy going to the MDA and one copy going to MCES.

Website information for the MCES/MDA Amalgam Recovery Program is maintained by the MDA at:

www.mndental.org (click on “Dental Professionals” on the left side of the homepage)5 

### Appendix A



## Hydraulic Testing of Amalgam Separators

As described in the Policy section of the document Administration of the List of Approved Amalgam Separators by Metropolitan Council Environmental Services & the Minnesota Dental Association:

“The addition or modification of an auxiliary component that may affect or regulate the flow (such as a “flow restrictor”) will not resu lt in the need for ISO retesting. However, hydraulic testing will be required in order to verify that the flow does not exceed the flow conditions present during ISO 11143 testing. Examples of modifications that may affect the flow through a separator incl ude (but are not limited to): addition of a flow restrictor, modification of a flow restrictor, changes to the volume or dimensions of a surge tank, and modifications of internal connections or plumbing within a separator.”

Appendix A is intended to g ive instructions to amalgam separator manufacturers/distributors and testing laboratories on conducting hydraulic testing of separators.

Basic instructions:

Present this document to the testing laboratory.

Hydraulic testing should be conducted to test the “worst case scenario” of flow through the amalgam separator since ISO calls for testing at the “maximum flowrate”. Therefore, water shall be run into the surge tank of the separator at a rate that will result in the surge tank being filled and continu ously overflowing at the top, thereby maintaining a steady

- state condition. (The overflowing excess water should be routed away from the separator, such as to a drain.)

The water flowrate passing through the collecting container of the separator is to be measured and reported. The testing laboratory should include with its report:

1. Amalgam separator model name/number.

2. Flowrate exiting the collecting container of the amalgam separator (expressed in milliliters/minute or liters/minute).

3. Photograph or a diag ram of the test setup.

4. Volume of the surge tank.

5. Dimensions of the surge tank.

6. Volume of the collecting container (volume of the cavity space, with whatever media/baffles are present inside).

7. Dimensions of the collecting container.

8. Serial number of the ama lgam separator (i.e., the main separator component which includes the surge tank).

9. Serial number of the collecting container.

10. Standard conditions normally recorded as present during the hydraulic testing (water temperature, ambient room air temperature, a mbient air humidity, and barometric pressure).6 Choosing and contracting with a hydraulic testing laboratory:

The manufacturer/distributor must contract with an independent hydraulic testing laboratory. [Note that the hydraulic testing laboratory may be different from the ISO 11143 testing laboratory.] The laboratory must be accredited by an accreditation body which is a “signatory to the International Laboratory Accreditation Cooperation’s Mutual Recognition Arrangement” (ILAC MRA). Examples of such a ccreditation bodies are the American Association for Laboratory Accreditation (A2LA) and the National Voluntary Laboratory Accreditation Program (NVLAP).

The laboratory’s scope of accredited services must include flow measuring of fluids, such as water.

Submittal of report and letter by the separator manufacture/distributor:

The separator manufacturer/distributor shall include with its submittal to the MCES/MDA Steering Committee, the hydraulic test report along with a signed letter stating that:

“The amalgam separator model (name/number) tested by (hydraulic testing lab name) is representative of the separator model being requested for inclusion on the MCES/MDA list of approved separators.”7 New Separator Model Is the separator a new model?

Yes No

Submit the separator to a testing laboratory (accepted by the Steering Committee) to be tested according to ISO 11143 and obtain a test report and a certificate. As

described in Part A of the Procedure Section, the test report, certificate, and “Features” table information shall be submitted to the Steering Committee for

cons ideration. The Steering Committee will then follow

Part B of the Procedure. Modified Separator Model Have modifications been made to the separator?

Yes No

Has the name and/or

model number of the separator ch anged? The manufacturer shall follow Part

A of the Procedure, and submit its information to the Steering Committee. The Steering

Committee will then follow Part B

of the Procedure.

The manufacturer shall follow Part A of the Procedure, explaining in its submittal that the separator has not been altered, only renamed. The Steering Committee will then follow Part B of the Procedure.

. Yes 

## Appendix B Decision Tree

This Decision Tree is designed to assist the reader in navigating the application process to list an approved separator.