From: "Berglund, Peter" <peter.berglund@metc.state.mn.us>

To: "'Jayne, Becky M.'" <Becky.Jayne@Illinois.gov>, Carey

 Johnston/DC/USEPA/US@EPA

Cc: Damon Highsmith/DC/USEPA/US@EPA, "Gilliam, Allen"

 <GILLIAM@adeq.state.ar.us>, John Gilkeson

 <John.Gilkeson@state.mn.us>, "Berglund, Peter"

 <peter.berglund@metc.state.mn.us>

Date: 04/12/2011 05:13 PM

Subject: RE: Information on Selecting Amalgam Separators

To all,

Thank you Becky for sending this out.

Just to tweak a couple little things in the e-mail below, please see the

comments I’ve inserted below after my initials, in blue.

Peter Berglund, P.E.

651-602-4708

peter.berglund@metc.state.mn.us

Metropolitan Council Environmental Services

Industrial Waste & Pollution Prevention Section

390 Robert Street North

St. Paul, MN 55101

From: Jayne, Becky M. [mailto:Becky.Jayne@Illinois.gov]

Sent: Tuesday, April 12, 2011 3:30 PM

To: Johnston.Carey@epa.gov

Cc: Highsmith.Damon@epamail.epa.gov; Gilliam, Allen; Berglund, Peter

Subject: FW: Information on Selecting Amalgam Separators

Sorry, I had the wrong address for you.

From: Jayne, Becky M.

Sent: Tuesday, April 12, 2011 3:29 PM

To: 'Johnson.Carey@epamail.epa.gov'; Highsmith.Damon@epamail.epa.gov

Cc: 'Gilliam, Allen'; 'Berglund, Peter'; John Gilkeson

Subject: Information on Selecting Amalgam Separators

Hi Carey and Damon –

I’m working with Allen Gilliam and Peter Berglund on dental amalgam

issues. They mentioned that amalgam separator selection came up during

your ELG call yesterday. I thought I’d share some information with you.

States with laws requiring the use of amalgam separators require that

they be certified as meeting the ISO 11143 standard.

PB: Some rules say “certified”, but when the regulators are questioned,

it is not always clear that tested does not also automatically mean

certified. In other words, certification is a separate, additional

function beyond testing, but this word gets added into regulations from

just common vernacular. In such a case, a separator manufacturer could

submit a test report, without a certificate, and the regulator may still

think that the separator is “certified”. A certificate is a separate

document than a test report.

The issue gets complicated because the company issuing the certification

must be accredited.

PB: I see the comment below, but just to clarify: A certification body,

or a lab for that matter, may not always be accredited. And even if they

are, there may be some question as to who the accreditor is. Is the
accreditation body a signatory to their international organization, or

are they operating “on their own” in some way? Also, for example,

another question is: Does the lab’s “scope of accreditation”

specifically list ISO 11143 as an accredited procedure that the lab can

perform?

Some of the companies issues certificates on amalgam separators are not

accredited. Things can be very confusing. Peter, John Gilkeson from MN

PCA, and myself have been working to address this issue. We feel that

having one source of information on amalgam separators will help ensure

that only amalgam separators that are tested properly are installed.

We drafted a document proposing a national review committee to review

all amalgam separators on the market. The information would then be

posted on a publicly available website (not selected yet) that

government folks and dentists can access. The only separators that would

be listed on the web site are those that were tested properly by an

accredited lab. Attached is the document we drafted. The Quicksilver

Caucus dental amalgam work group has looked at it, but the entire QSC

has not blessed it, so it is marked as draft. Peter has another

document that goes into more specifics, but I thought I’d send you the

attached document first. Peter Berglund is much more versed on the

entire certification and accreditation issues than I am. So, if you

have questions you can contact him at Peter.Berglund@metc.state.mn.us.

Let me know if you have any questions.

Regards,

Becky

|----------------------------------+------------------------|

|cid:image005.png@01CB97B5.32173E90|Becky Jayne |

| |Illinois Environmental |

| |Protection Agency |

| |Office of Pollution |

| |Prevention |

| |1021 N. Grand Ave East |

| |Springfield, Illinois |

| |62794 |

| |Becky.Jayne@illinois.gov|

| |Phone: (217) 524-9642 |

| |Fax: (217) 557-2125 |

|----------------------------------+------------------------|

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