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ENVIRONMENTAL RISKS OF AND REGULATORY

RESPONSE TO MERCURY DENTAL FILLINGS

HEARING

BEFORE THE

SUBCOMMITTEE ON DOMESTIC POLICY

OF THE

COMMITTEE ON OVERSIGHT

AND GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED TENTH CONGRESS

FIRST SESSION

NOVEMBER 14, 2007

Serial No. 110–161

Printed for the use of the Committee on Oversight and Government Reform

(

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html

http://www.oversight.house.gov

(II)

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

HENRY A. WAXMAN, California, Chairman

TOM LANTOS, California

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

BRIAN HIGGINS, New York

JOHN A. YARMUTH, Kentucky

BRUCE L. BRALEY, Iowa

ELEANOR HOLMES NORTON, District of

Columbia

BETTY MCCOLLUM, Minnesota

JIM COOPER, Tennessee

CHRIS VAN HOLLEN, Maryland

PAUL W. HODES, New Hampshire

CHRISTOPHER S. MURPHY, Connecticut

JOHN P. SARBANES, Maryland

PETER WELCH, Vermont

TOM DAVIS, Virginia

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

JOHN J. DUNCAN, JR., Tennessee

MICHAEL R. TURNER, Ohio

DARRELL E. ISSA, California

KENNY MARCHANT, Texas

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

VIRGINIA FOXX, North Carolina

BRIAN P. BILBRAY, California

BILL SALI, Idaho

JIM JORDAN, Ohio

PHIL SCHILIRO, Chief of Staff

PHIL BARNETT, Staff Director

EARLEY GREEN, Chief Clerk

DAVID MARIN, Minority Staff Director

SUBCOMMITTEE ON DOMESTIC POLICY

DENNIS J. KUCINICH, Ohio, Chairman

TOM LANTOS, California

ELIJAH E. CUMMINGS, Maryland

DIANE E. WATSON, California

CHRISTOPHER S. MURPHY, Connecticut

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

BRIAN HIGGINS, New York

BRUCE L. BRALEY, Iowa

DARRELL E. ISSA, California

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

CHRIS CANNON, Utah

BRIAN P. BILBRAY, California

JARON R. BOURKE, Staff Director

(III)

C O N T E N T S

Page

Hearing held on November 14, 2007 ...................................................................... 1

Statement of:

Clark, Ray, senior partner, the Clark Group, LLC; Michael T. Bender,

executive director, Mercury Policy Project; Dr. C. Mark Smith, cochair, Mercury Taskforce, New England Governors’ Conference; and

Dr. J. Rodway Mackert, dentist and faculty member, Medical College

of Georgia ...................................................................................................... 49

Bender, Michael T. .................................................................................... 58

Clark, Ray .................................................................................................. 49

Mackert, J. Rodway ................................................................................... 94

Smith, C. Mark .......................................................................................... 86

King, Ephraim, Director, Office of Science and Technology, Office of

Water, U.S. Environmental Protection Agency; and Norris Alderson,

Director, Office of Science and Health Coordination, Food and Drug

Administration, U.S. Department of Health and Human Services .......... 9

Alderson, Norris ........................................................................................ 20

King, Ephraim ........................................................................................... 9

Letters, statements, etc., submitted for the record by:

Alderson, Norris, Director, Office of Science and Health Coordination,

Food and Drug Administration, U.S. Department of Health and Human

Services, prepared statement of ................................................................... 22

Bender, Michael T., executive director, Mercury Policy Project, prepared

statement of ................................................................................................... 61

Clark, Ray, senior partner, the Clark Group, LLC, prepared statement

of ..................................................................................................................... 53

Cummings, Hon. Elijah E., a Representative in Congress from the State

of Maryland, prepared statement of ............................................................ 113

King, Ephraim, Director, Office of Science and Technology, Office of

Water, U.S. Environmental Protection Agency, prepared statement of ... 13

Kucinich, Hon. Dennis J., a Representative in Congress from the State

of Ohio, prepared statement of .................................................................... 4

Mackert, Dr. J. Rodway, dentist and faculty member, Medical College

of Georgia, prepared statement of ............................................................... 96

Smith, Dr. C. Mark, co-chair, Mercury Taskforce, New England Governors’ Conference, prepared statement of ................................................. 89

(1)

ENVIRONMENTAL RISKS OF AND REGULATORY RESPONSE TO MERCURY DENTAL

FILLINGS

WEDNESDAY, NOVEMBER 14, 2007

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON DOMESTIC POLICY,

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM,

Washington, DC.

The subcommittee met, pursuant to notice, at 2:34 p.m., in room

2154, Rayburn House Office Building, Hon. Dennis J. Kucinich

(chairman of the subcommittee) presiding.

Present: Representatives Kucinich, Burton, Cummings, and Watson.

Staff present: Jaron R. Bourke, staff director; Jean Gosa, clerk;

Nidia Salazar, staff assistant; Leneal Scott, information systems

manager; Benjamin Chance, minority clerk; and Jill Schmalz, minority professional staff member.

Mr. KUCINICH. The Subcommittee on Domestic Policy of the Committee on Oversight and Government Reform will now come to

order.

Today’s hearing will examine the environmental risks and regulatory response to dental mercury.

I ask unanimous consent that all opening statements, written

statements, other materials be inserted into the record and, without objection, the Chair and the ranking minority member will

have 5 minutes to make opening statements followed by opening

statements not to exceed 3 minutes by any other Member who

seeks recognition.

Without objection, Members and witnesses may have 5 legislative days to submit a written statement or extraneous materials for

the record.

To my right is the Honorable Dan Burton of Indiana with whom

I have had the honor of serving on this committee and the full committee for many years, and to my left is the Honorable Diane Watson, the gentlelady from California who I am pleased to serve with

in this House and whose work together with Mr. Burton has

brought us to this important discussion today.

Mercury is toxic to the environment. It is a naturally occurring

toxin and a manmade pollutant. It bioaccumulates, meaning that

even and ever higher concentrations buildup in organisms at higher levels of the food chain.

Mercury toxicity causes brain and liver damage, even death. The

FDA advises women of childbearing age and children to avoid cerVerDate 11-MAY-2000 11:32 Jun 05, 2009 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 U:\DOCS\49626.TXT KATIE PsN: KATIE
2

tain kinds of fish and limit their intake of others due to levels of

methylmercury in those tissues.

Mercury, in the elemental form, is present in the teeth of many

Americans. According to the EPA, dentists use between 34 to 54

tons of mercury per year to create or replace mercury dental fillings in Americans. Dentists are the third largest category of user

of mercury in the economy, and existing dental fillings account for

more mercury in use at the current time than any other application

including thermometers, batteries, switches and paints, over 1,000

tons.

Methylmercury, which is the most toxic and mobile form of mercury, is created through the actions of microbes and by combustion

of mercury-containing materials. Dental mercury becomes

methylmercury when the mercury-containing byproduct of sewage

treatment plants, known as sludge, is incinerated and when it is

applied to agricultural land. Methylmercury is created when

corpses containing mercury dental fillings are cremated.

How significant is dental mercury to the emission of mercury

into the environment? Assessing the question is one of the purposes

of this hearing.

According to the U.S. Environmental Protection Agency, it would

seem that with all the mercury in use and annually used in dentistry, only a tiny fraction is emitted into the air. But there is reason to believe that the EPA’s estimates significantly understate the

reality.

For instance, EPA estimates airborne mercury attributable to

sludge incineration to be 0.6 tons per year annually. However, EPA

admits that its mercury emission data for sludge incineration is

poor, a deficiency it attributes to both the small number of facilities

tested and the fact that these facilities were not a random sample

of the industry.

The Northeast States for Coordinated Air Use Management estimated that mercury emissions in the northeast alone amount to 0.5

tons per year.

EPA estimates of total mercury emitted as a byproduct of cremation of human remains is around 0.3 tons per year. However, EPA’s

estimate might significantly understate the magnitude of mercury

emissions from this source as well.

A newly published article authored by the EPA environmental

scientist estimates mercury emissions from cremation to be 10

times more than the EPA estimate, about 3 tons per year or 10

EPA’s estimate.

Indeed, today, the Mercury Policy Project will testify that total

actual mercury emissions could be as much as five to six times the

EPA’s estimates.

Why is this important? It is important because the EPA

prioritizes its activities based in part on this number.

EPA’s only dental-specific initiative is its so-called gray bag program. This is a voluntary program to encourage student dentists

to collect mercury amalgam before it enters the wastewater stream.

A voluntary educational outreach program might be justified for a

de minimis pollution source, but it may not be appropriate for a

source as significant as dental mercury.

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EPA does not seem to be alone in tolerating the significant understatement of dental mercury’s threat to the environment. Mercury dental devices are regulated by the Food and Drug Administration.

The FDA, with all Federal agencies, is legally required to consider the environmental requirements imposed by the National Environmental Policy Act of 1969. The NEPA requires an environmental assessment or environmental impact statement for all governmental actions that have a significant effect on the environment.

Dental fillings are subject to regulation under the Medical Device

Amendments of 1976. Medical Device Amendments mandated that

all devices in use prior to enactment be reviewed and classified

pursuant to the act.

FDA did classify the component materials, liquid mercury and

amalgam powder, separately in 1987, and it began the process for

classifying dental mercury amalgam by promulgating a proposed

rule in 2002. However, the FDA did not take steps to finalize the

classification rule and, as of now, the dental mercury amalgam

used in dental offices remains an unclassified medical device.

One of the concerns shared by advocates and the FDA is the appropriateness of the FDA’s 1987 action classifying liquid mercury

as safe for general use. Devices receiving this classification are not

subject to much regulation, and other devices so classified include

toothbrushes.

One of the questions this hearing will consider is whether or not

the FDA’s classification of dental mercury amalgam does in fact require environmental reporting because of possible significant effects on the environment. It has been the FDA’s position that the

classification does not have such an effect and thus no reporting is

required, but they may be unique in holding this view as our witnesses will testify.

Mercury is a danger for the environment, and dentistry seems to

be a significant contributor to that environmental threat. Today,

we will examine the magnitude of the threat and the steps being

taken to mitigate the environmental damage.

[The prepared statement of Hon. Dennis J. Kucinich follows:]

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Mr. KUCINICH. There is a vote on and so, excuse me a minute,

I am going to confer with my colleagues.

We are going to take a 15 minute recess. There is a vote on. We

should be back perhaps even before then, but the Chair declares

a recess for 15 minutes.

I want to thank our witnesses for their patience. This is a flow

here that we don’t have total control over. We will be right back.

[Recess.]

Mr. KUCINICH. Thank you for your patience. Now, this committee

is back in session.

The members of the committee have agreed that they will submit

their opening statements for the record, and I want to thank them

for their cooperation, and we will move right to the opening statements of the witnesses.

[Witnesses sworn.]

Mr. KUCINICH. Let the record show that the witnesses answered

in the affirmative.

We have the following witnesses:

Mr. Ephraim S. King has been Director of the Office of Science

and Technology in the U.S. Environmental Protection Agency’s Office of Water since May 2005. Prior to that office, he was a Division

Director and Branch Chief in the Office of Ground Water and

Drinking Water for 9 years. From 1987 to 1996, he was Chief of

the National Pollutant Discharge Elimination System. Welcome.

Dr. Norris Alderson, Associate Commissioner for Science, Food

and Drug Administration [FDA], the majority of his FDA career

has been in the Center for Veterinary Medicine, holding a number

of management positions culminating in the position of Director,

Office of Research. In 2001, he became Acting Senior Advisor for

Science and Acting Director, Office of Science Coordination and

Communication. In 2002, he was appointed Senior Associate Commissioner for Science and Director, Office of Science and Health

Coordination. That title was later changed to Associate Commissioner for Science.

Mr. King and Dr. Alderson, I would ask that each of you give a

brief summary of your testimony, keeping the summary under 5

minutes in duration. Your complete written statement will be included in the hearing record.

So, Mr. King, you will be our first witness and you may proceed.

Thank you.

STATEMENTS OF EPHRAIM KING, DIRECTOR, OFFICE OF

SCIENCE AND TECHNOLOGY, OFFICE OF WATER, U.S. ENVIRONMENTAL PROTECTION AGENCY; AND NORRIS

ALDERSON, DIRECTOR, OFFICE OF SCIENCE AND HEALTH

COORDINATION, FOOD AND DRUG ADMINISTRATION, U.S.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

STATEMENT OF EPHRAIM KING

Mr. KING. Thank you, Mr. Chairman and members of the committee. I appreciate the opportunity to discuss mercury and dental

amalgam and the steps that EPA is taking to address its release

as well as other releases of mercury from other sources in the environment.

10

Your opening statement outlined the persistent and widespread

nature of mercury releases. EPA fully recognizes this and, for EPA,

mercury releases are a very, very high priority and a major focus.

Today, what I would like to do is talk a little bit about how EPA

is using its legislative authorities to address mercury releases, both

generally and in the context of dental amalgam. The two statutes

I am going to focus on are the Clean Water Act and the Clean Air

Act.

Under the Clean Water Act, I think the point that we would like

to make is that in establishing water quality standards, those

standards operate to drive publicly owned treatment works, municipal wastewater treatment systems around the country, to drive

their efforts to control the introduction of mercury amalgam from

dental offices down sewer systems.

A good example of that is some standards in the Great Lakes,

1.3, 1.8 nanograms per liter. Those standards are extremely challenging to meet and what they have operated to do is encourage

municipalities in that region to really focus hard on the contribution of dental amalgams and what can be done to reduce their contribution.

The other point I would make is that we and the Clean Water

Program also regulate biosolids. When a dental amalgam, if it is

not captured in the dentist’s office by a separator or by a trap, it

goes down into the sewer system. It goes into the POTW, the treatment works. The treatment works generally get about a 99 percent

removal efficiency which means that most of whatever waste is

there then goes into the biosolids and those biosolids are regulated

by EPA under Section 503 of the Clean Water Act.

A recent report by AMSA, 2002, concluded that in terms of mercury release into the environment, probably less than 1 percent of

the releases into the environment for mercury come from municipal

treatment works and dental amalgam.

If I turn to the Clean Air Act, this is an area where EPA has

made very substantial progress over the last several years with the

establishment of maximum achievable control technology standards

for municipal waste combustion and for medical waste incineration.

Mercury emissions from those two sources alone have been reduced

by over 90 percent.

More recently, in 2005, with the promulgation of the Clean Air

Mercury Rule, emissions from coal-fired utilities will be reduced by

over 70 percent, and we regard that as very substantial progress.

Applying these authorities to mercury and dental waste, sort of

to start this part of the conversation, we simply start in the dentist’s office and observe that the wastes themselves come from the

new fillings as well as replacing old fillings. The waster is then put

into a screen or a chair-side drain.

There are tools available—amalgam separators, traps, screens—

to reduce that solid waste. The waste then either goes to recycle,

which we strongly encourage, or to solid waste disposal.

One of the examples that I am going to give in terms of the

amalgam separator, the city of San Francisco has set a goal of all

900 of its dental offices putting in amalgam separators, and it also

has a goal of providing incentives for the low income areas to support those dental offices. We think that is a terrific example of a

11

city using this new technology to reduce the generation of mercury

amalgams going into the sewer system, highly effective.

The other point we would make is that when you go into the

sewer systems themselves, if you look at sewage sludge, EPA 503

standards apply to land application. We have standards that limit

the amount of mercury that can go into land-applied sludge, and

we also have air emission standards that limit the amount of mercury that can be emitted from incineration.

One particular item that may be of interest to the committee is

that in 2006, this past year, EPA has undertaken a study of certain

portions of the health services industry. One part of that are dental

offices and the discharge of amalgams with mercury from dental offices, and we will be completing that study probably in the fall of

2008. We expect that information will give us a lot of valuable data

on the volumes and the kinds of BMPs and practices that are being

engaged in there.

Under the Clean Air Act, one of the questions being asked by the

committee is the significance of dental amalgam mercury emissions. One of the points that we would make in this hearing is that

EPA regards these missions as important. As we compare them,

however, to other national sources of mercury emissions, we conclude, based upon the information to us, that they are a relatively

small proportion of national emissions of mercury.

One of the things we would point out is that our focus on the air

program has been to focus on the largest contributors of air emissions and that is why, for example, we have focused on coal-fired

utilities. That is why we have focused on medical waste incinerators and why we have focused on the municipal combustion.

One area we would like to emphasize is the whole area of waste

minimization and prevention. I mentioned amalgam separators.

That is a great example of taking the wastes and making sure they

don’t get into the sewer, so they don’t get into the environment

which is the goal that we all have.

Another area that we would point out, another example of a publicly owned treatment work that has done a great job responding

to Clean Water Act standards for mercury is Duluth, Minnesota.

That POTW took a look at its water standards. It then asked the

question, where was the mercury from in the POTW? The answer

is a single industry and a whole number of smaller sources.

That utility worked with its dental offices to develop a practice

manual and reduce the discharges from dental offices by over twothirds, a great example of a POTW affirmatively engaging and

doing a terrific job.

The only other point I would make under our legislative authorities and how they relate to dental amalgam is that we established

a fish tissue criteria for specifically methylmercury which, Mr.

Chairman, you mentioned in your opening statement. That limit is

0.3 parts per million, and it has been adopted by 13 States and five

tribes.

That standard, as a water quality standard, will in turn drive

again municipal wastewater systems to go back up the pipe and

ask the question, how can we effectively reduce the discharge or

contribution from dental offices and mercury amalgam?

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Finally, Mr. Chairman, I would just like to highlight the joint

public health partnership between EPA and FDA. You referred

briefly to a fish advisory, a health advisory that has been issued

by our two organizations in 2004, and that health advisory is, in

essence, advising women of childbearing age, women who are pregnant, nursing, or young children not to eat more than 12 ounces

of fish a week.

There have been national reports recently indicating that women

should eat unlimited amounts of fish, and we simply want to take

this occasion to affirm that the FDA and EPA continue to strongly

stand behind their advice which is don’t eat more than 12 ounces

of fish and the fish that you do eat should be low in mercury. This

is something we think makes an awful lot of sense and protects

public health.

In closing, Mr. Chairman, I want to thank the committee for the

opportunity to share with you the work that EPA is doing both in

the air program and in the water program. We are committed to

understanding and reducing mercury releases into the environment.

One final note that I would make is an additional resource that

would be available to the committee—you may already have it—is

EPA’s 2006 Roadmap to Mercury which lays out much more comprehensively the full range of activities that the Agency is doing.

Thank you very much. That concludes my testimony.

[The prepared statement of Mr. King follows:]

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Mr. KUCINICH. I thank the gentleman.

Dr. Alderson, thank you.

STATEMENT OF NORRIS ALDERSON

Mr. ALDERSON. Mr. Chairman and members of the subcommittee,

we appreciate your invitation and the opportunity to discuss the

issue of dental amalgam and FDA’s implementation of the National

Environmental Policy Act of 1969 with respect to dental amalgam.

Dental amalgam is a restorative material that is used for the direct filling of carious legions or structural defects in teeth. It is

made onsite in a dentist’s office by mixing elemental mercury and

powdered alloy composed of primarily of silver, tin and copper.

The Medical Device Amendments of 1976 to the Food, Drug and

Cosmetic Act gave FDA specific authority to regulate the safety

and effectiveness of medical devices. Dental amalgam as well as its

components are medical devices.

Devices that were first introduced into commercial distribution

after enactment of the Medical Device Amendments are known as

post-amendments devices.

Devices that were in commercial distribution before the enactment of the Medical Device Amendments are commonly referred to

as pre-amendments devices and were assigned to one of three

classes: Class I, II or III. This classification is based on risk and

controls necessary to provide reasonable assurance of safety and effectiveness.

The act also has a specific procedure for effecting a change to the

classification of a pre-amendments device.

Accordingly, in a rule published on August 12, 1987 and based

on the comments received, FDA placed dental mercury in Class I

and amalgam alloy into Class II. FDA agreed with the comments

urging that dental mercury be classified into Class I.

The encapsulated form, encapsulated amalgam, was not separately classified during the original classification process. However,

FDA has regulated the encapsulated form as a Class II device in

accordance with the requirements applicable to the component of

the higher classification.

The Dental Products Panel of the Medical Devices Advisory Committee met in 1993 and 1994 to discuss the classification, reclassification and safety of dental amalgam devices. The panel unanimously recommended to classify dental mercury and amalgam alloy

into Class II with special controls.

The panel stated that there were no major risks associated with

encapsulated amalgam when used as directed but recognized there

was a small population of patients who may experience allergic reactions to the materials in the device. The panel also noted that

improper use of the device by practitioners presented risk associate

with mercury toxicity.

In February 2002, FDA proposed a rule to bring all amalgam

products into Class II and increase the Agency’s regulatory oversight over these devices by requiring ingredient labeling and proposing conformance to international standards. FDA twice reopened the comment period and received more than 750 comments

on this proposal.

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The majority of the comments stated that the Agency was not

proposing enough restrictions on the marketing and use of dental

amalgam and that the proposed special controls do not adequately

address the potential health risks of the device.

Numerous U.S. Public Health Service reviews of the safety and

use of dental amalgam conducted in the 1990’s concluded that the

available studies did not support claims that individuals with dental amalgam restorations will experience problems including

neurologic, renal or developmental effects, except for rare allergic

or hypersensitivity reactions.

In 2006, FDA held a joint meeting of the Dental Products Panel

and the Peripheral and Central Nervous System Drugs Advisory

Committee to address a series of questions FDA had posed. The

committee asked FDA to expand its literature review to include additional data bases and searches.

They agreed that the most recent well controlled clinical studies

showed no evidence of neurological harm from dental amalgam and

generally agreed that there is no evidence that dental amalgam

causes health problems in the vast majority of the population.

While the committee did not take consensus votes on these

issues, non-consensus opinions included a panelist recommendation

that FDA consider labeling requirements related to the use of dental amalgam in pregnant women and small children as well as patient information to ensure that consumers understand these devices contain mercury. The comments on that meeting drew 3,500

comments.

As for the National Environmental Policy Act, FDA’s regulation

implementing the National Environmental Policy Act are contained

in 21 CFR 25: Environmental Impact Considerations. This regulation describes Agency actions that require preparation of an environmental assessment, actions that require preparation of an environmental impact statement and those Agency actions that are categorically excluded from the requirement to prepare an environmental assessment or an environmental impact statement, absent

extraordinary circumstances.

It should be clarified that the analysis is determined by the action taken by the Agency, not the product in question.

The 2002 proposed rule cited the categoric exclusion contained in

21 CFR 23, 24(b) which categorically excludes the classification or

reclassification of a device from the requirement to prepare an environmental assessment. If it is not reasonably foreseeable that

there would be any effect in the amount of mercury introduced into

the environment that would constitute an extraordinary circumstance, the Agency would appropriately rely on its existing categorical exclusion for such an action.

Mr. Chairman, we continue to evaluate the available information

to determine appropriate next steps to fulfill the Agency mission of

protecting and promoting public health.

Thank you again for this opportunity, and I will be glad to answer any questions.

[The prepared statement of Mr. Alderson follows:]

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Mr. KUCINICH. Thank you, Dr. Alderson.

We are going to begin with questions of Mr. King. I will ask

questions for 5 minutes, and then I will go to my colleague, Mr.

Burton, who will ask questions and then to Ms. Watson who will

continue.

Now, Mr. King, you have testified that dental amalgam contributes a small proportion of all mercury release into the environment, but there is reason to doubt EPA’s assessment. I want to go

over the data with you, just follow it along.

How much mercury do dental offices use each year? What is your

EPA estimate?

Mr. KING. We estimate about 34 tons go into a dental office.

Mr. KUCINICH. That is the lowest. Does it go as low as 34 and

as much as how much?

Mr. KING. I don’t have the upper end, but 34 is what we sort of

start with.

Mr. KUCINICH. How does that compare with the amount of mercury used to thermostats and thermometer?

Mr. KING. I don’t have that information.

Mr. KUCINICH. Is it more or is it less?

Mr. KING. But I would be happy to get it for you, happy to provide it for the record.

Mr. KUCINICH. Well, I would like to see what you have.

The information that our staff put together is that it is actually

more, that thermostats contribute 15 to 21 tons per year; thermometers, 9 to 17 tons per year; and that the high end that we have

from other EPA documents with respect to dental amalgam mercury source, 34, the low end, as you pointed out, to 54 tons per

year.

Do you have any knowledge or any estimates of how much mercury is estimated to be currently in teeth of the American people?

Do you have any estimates of that?

Mr. KING. Forgive me. Could you repeat that question?

Mr. KUCINICH. Are you familiar with any general estimates of

how much mercury is right now in the form of dental amalgams

that people have in their mouths?

Mr. KING. No, sir, I don’t have that information.

Mr. KUCINICH. OK. It is, according to staff information, this is

an EPA number, by the way. It is 1,200 tons. Does that number

sound familiar to you now?

Mr. KING. It does not, but I would be happy to confirm it if you

would like.

Mr. KUCINICH. But what is your position with the EPA?

Mr. KING. Mr. Chairman, my position is I am Director of the Office of Science Technology in the Office of Water, and my expertise

lies in the area of water quality standards and technology-based information.

Also, Mr. Chairman, our position and our view and what we are

trying to communicate to this committee is that we, in fact, regard

mercury as a very significant issue and that we think we have

taken a number of steps under the Clean Water Act that will establish water quality standards to drive more effective control of

mercury amalgam, and we believe under the Clean Air Act that we

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have established regulations which have resulted in very significant reductions of mercury emissions.

Mr. KUCINICH. Well, since your knowledge isn’t in the areas of

quantification, then let’s go to an area that might be closer to your

area of expertise. What is the percentage of mercury ending up in

municipal sewage treatment plants that comes from dental offices?

Mr. KING. The numbers range anywhere from 20 to 30 percent.

Mr. KUCINICH. Could it be as high as 36 percent?

Mr. KING. Yes.

Mr. KUCINICH. Now, as you know, the report of the 31st Conference of New England Governors and Eastern Canadian Premiers

Mercury Taskforce Activities and Workplan puts the figure closer

to 50 percent. Have you seen that report?

Mr. KING. I have not seen that report. I think one of the things

we like to emphasize, we are entirely open and welcome to new information. Our position is not to challenge the new information but

rather to sit down and understand it.

Under the Clean Water Program, we would continue to move forward trying to strengthen perturbment programs and trying to

strengthen the relationship between municipal waste systems and

their abilities to work with dental offices to reduce amalgam.

Mr. KUCINICH. Now a lot of sludge byproduct of sewage treatment plants is incinerated. What is EPA’s estimate of airborne

mercury attributable to sludge incineration?

Mr. KING. About 0.6 tons.

Mr. KUCINICH. Is EPA very confident in that number?

Mr. KING. Mr. Chairman, I am confident that is the current

number that our air program has in Research Triangle Park. One

thing that you learn after a while working with scientists, that

there is always new science. There are new data, new methodologies, and I am aware there is recently an article out indicating that

number could be higher.

Mr. KUCINICH. Thank you.

Isn’t it true that the EPA has admitted its mercury emission

data for sludge with respect to incineration is poor? Can you tell

us why the EPA’s confidence in this number as poor?

Mr. KING. That would go to simply the number of facilities that

we have sampled at and the more facilities you sample, the broader

the random sample, the more information available to you and the

greater the strength of your confidence.

Mr. KUCINICH. I assume that you do know that the Northeast

States for Coordinated Air Use Management estimated that mercury emissions in the northeast alone amount to 0.5 tons per year.

Mr. KING. I am aware of that number, yes.

Mr. KUCINICH. So is it impossible that the real national emissions number is considerably higher?

Mr. KING. It is possible, and that is something we are more than

happy to take a look at.

Mr. KUCINICH. Could it be two tons? Could it be four? Could it

be two tons?

Mr. KING. I would be very cautious about offering you a number

on that, sir.

Mr. KUCINICH. I understand that you would be cautious. Could

it be four tons?

33

Mr. KING. I would welcome the opportunity.

Mr. KUCINICH. You really don’t know is what you are saying.

Mr. KING. The number that I have is the 0.6. We would be delighted to sit down with additional researchers and get more data

on that.

Mr. KUCINICH. We are going to come back. I am going to recognize Mr. Burton of Indiana.

Thank you, Mr. Burton, for being here. You have the rostrum

here. Go ahead.

Mr. BURTON. Thank you, Mr. Chairman.

We had a hearing in October 2003, and in it we had testimony

that collectively Americans are walking around today with 800

metric tons of mercury in their mouths and tens of millions of mercury-containing fillings continuing to be put into Americans’ teeth

every single year.

What I can’t figure out, and we have a list of facts about mercury

that is almost two pages long and the reference material that goes

with it, talking about how mercury amalgams affect not only the

environment but the people that have these things in their mouths.

Have you ever seen any of this? Have you ever seen these?

I mean there are references for every one of these facts. Have

you seen this?

Mr. KING. Mr. Representative, I don’t believe I have seen that

particular document.

Mr. BURTON. I want to give both of you a copy of this. Would you

make a copy and make sure both of them get it.

Mr. KING. Thank you.

Mr. BURTON. The thing that bothers me—I don’t know that I am

going to have a whole bunch of questions—is we have been holding

hearings on this for years when I was chairman and up to now,

and the FDA and the EPA continue to say, well, you know, don’t

eat over 12 ounces because of the mercury, and you have to be

careful about burning things that have mercury in them because

it gets into the atmosphere, and you have to be careful about the

mercury getting into landfills because it leaches down into the

water supply and causes contamination of the water.

Yet, we continue to say that the mercury in your mouth doesn’t

have an adverse impact on human beings. I just don’t get it.

If when it goes into the dentist’s office, when they are mixing it,

it is dangerous. They put it into your mouth, and it is not hard yet.

It is still dangerous. While it is in your mouth, it is not dangerous

anymore. But when it comes out of your mouth, it is dangerous.

Everything in the environment that has mercury in it is dangerous but not when it is in your mouth. I just don’t get it.

We had hearings, with Ms. Watson being one of the major contributors, on vaccinations. When I was a boy, we had no vaccinations and when you got measles, they put a sign on the front of

your house, saying quarantined. But today a child gets as many as

28 to 30 vaccinations before they start the first grade.

We have gone from 1 in 10,000 children that are suffering from

neurological disorders to 1 in about 140 now. It is an absolute epidemic, and yet our health agencies continue to say that the mercury in the vaccines has no impact on that and they say that the

mercury in the amalgam doesn’t have any impact on it.

34

There has to be some doubt. There has to be some doubt. Even

if you don’t agree with the scientific facts that I have before me,

there has to be some doubt. If there is doubt, why do we continue

doing it?

Why do we continue putting mercury in vaccinations when there

is doubt about the amount of autism and other neurological disorders that are being caused because of it?

Why do we keep putting mercury in amalgams in people’s

mouths when there is doubt even among you folks about what kind

of a neurological problem it creates?

We just keep going on, and it makes me wonder if maybe the

medical institutions and the dental institutions have too much influence with our health agencies. It really bothers me, and I don’t

understand. I am sure you are not going to give me an answer to

this because I am more or less filibustering on the issue, but it

really bothers me.

Eventually, eventually, our health agencies are going to have to

come to grips with the facts as they have about the mercury in fish,

that mercury in any way into the human body is a threat. It is just

a threat, and we are not doing a daggone thing about it.

You guys come up here, and we have been doing this since I was

chairman back in the years 1998 to 2004, and you keep saying the

same things over and over again, and nothing changes. More kids

become neurologically damaged, more ancillary impacts from mercury.

Yet, our health agencies keep saying, well, it is not really any

problem. It is not really a problem. Don’t eat too much fish, but

don’t worry about the amalgams in your mouth. Don’t worry about

the shots that contain 50 percent methylmercury. Don’t worry

about any of that stuff. It isn’t going to hurt you any.

But the facts are people are being damaged and even if mercury

is a minor threat, it should be taken out of everything.

Let me just say, Mr. Chairman, here in Washington, DC, we had

a little bit of mercury that was spilled in a classroom. They evacuated the school, burned everybody’s clothes and just went through

great efforts to make sure that there was no mercury in there.

In my district back in Indiana, they spilled a very small container of mercury in a city area. They evacuated the neighborhood,

brought in firemen who looked like they were wearing spacesuits

to clean that mess. Yet, we put mercury in our bodies, and you

guys keep saying it is not any problem.

Eventually, eventually, the FDA and our health agencies are

going to be really ashamed of themselves because it is going to be

proven beyond a reasonable doubt that it is a major contributing

factor to these neurological disorders, and everybody that comes up

here and says that it isn’t, history is going to show that you

weren’t doing the right kind of job for the American people that

you should.

If there is any doubt whatsoever about mercury being put into

a human being, being a damaging substance, then why don’t we get

it out of all of it?

We can give shots with no mercury, single shot vials. We can

give dental fillings without any mercury in them. So why don’t we

do it?

35

I just don’t understand it.

I have one question. Can I ask one question?

Mr. KUCINICH. You can ask any questions.

Mr. BURTON. OK, let’s let Ms. Feinstein go. Thank you, Mr.

Chairman.

Mr. KUCINICH. Senator.

Ms. WATSON. Ms. Feinstein here. [Laughter.]

I want to thank our chairman and I want to thank our ranking

member for being sensitive to this issue. Now, everyone out there,

you are looking at a person who had mercury poison, and just

today I had to change my clothing. I had to send to my home to

get a new set of clothing because I found out that the chemical in

the knit that I had on was making me sick. I was violently ill earlier today.

So I appreciate this hearing being delayed because I was getting

blurry. I was getting woozy and so on, and I had to go to Mexico

to a dentist there.

I had my fillings put in when I was 9 years old. My father was

a police officer in Los Angeles. You used to be able to go to the clinic, and pretty much they were free. I was wondering why I was

having so much trouble with my blood and splotches and so on.

You know children break teeth all of the time. Teeth fall out all

of the time. Teeth are pulled all of the time.

Every time you touch that amalgam, there is an emission. I was

tested. I could look up at that screen, and I could see the fumes.

They go right up to the T-zone, and they attack the meninges. That

is that thin skin over the brain, Mr. King. They attack the

meninges.

I can’t, for the life of me, understand why we would risk putting

it into amalgam, and you are saying it is well sealed. Well, tell that

to the children who are riding their bikes, flip over, break their

teeth, and they have an amalgam filling.

So I think the two of you have agreed that mercury in the environment, it is very toxic.

Mr. KING. Yes, ma’am.

Ms. WATSON. Both of you.

What is really hard for me to understand, and I have been at

this for the last maybe 20 years now. I chaired the Health and

Human Services Committee in the California State Senate for 17

years.

Before I left there, being termed out in 1998, I had a bill that

would require the Dental Board to come up with a brochure so that

a patient, a parent of a patient could know what was in that dental

filling and make a choice. It took 17 years to get the Dental Board

to do that.

Now, why? Why would they not want to alert you to what goes

in your body?

It boggles my mind as a person who takes an oath to do no harm.

I like to call it the Hypocritic Oath as in Hippocratic Oath.

It took us all those years. The administration had to change, dissolve the board, have a new board before we could get it done. We

had a hearing. My colleague was with us at USC, if you remember,

and we discussed that. The doctors who were all for it before were

put off the board.

36

What is going on?

I would like to ask you this, and I am going to address this to

Dr. Alderson. Are you a Ph.D. or are you an M.D. or a dentist,

D.D.S.?

Mr. ALDERSON. Ph.D.

Ms. WATSON. OK. I am too, and I have to make the clarification

when I am outside of this arena when they call me doctor.

Mr. ALDERSON. I understand.

Ms. WATSON. I am not an M.D., but I think I have had enough

experience in the medical profession to feel like I have the accumulative knowledge to be an M.D.

What boggles my mind is that it just seems clear that the FDA

cannot categorically state there is no significant impact of the use

of mercury, and how do they know?

Mr. King, you weren’t aware of the figures, and you said you

don’t work in that department. But do you know, Mr. King, that

dentists are the third largest users of mercury?

Mr. KING. Yes, ma’am.

Ms. WATSON. You know that, OK. They account for 34 tons of

mercury per year. You can followup on this fact. I am just throwing

it out to you.

Can you tell me how—and I am going to address this to Dr.

Alderson—how do you know that mercury cannot be classified as

a very toxic and harmful ingredient to put into something that is

in the mouth of a human for a while?

Mr. ALDERSON. I am not sure I understand the question, but I

think you are asking.

Ms. WATSON. Well, you have not done, as I understand, a comprehensive environment assessment, true?

Mr. ALDERSON. That is correct.

Ms. WATSON. OK, that I am aware of. At a minimum, there is

some scientific disagreement on the point and the amount and the

harm that mercury can do, and I am wondering why the FDA has

not done its own environmental assessment.

Mr. ALDERSON. Dental amalgams have been used for now over

100 years.

Ms. WATSON. We understand that.

Mr. ALDERSON. OK, and the classification in our regulations

under the National Environmental Policy Act, our regs provide that

unless there are extraordinary circumstances resulting from an action we have taken—in this case, we are talking about a reclassification and classification as it relates to the amalgam itself—that

we do not have to go back and do an environmental assessment

unless——

Ms. WATSON. Wait a minute. Wait a minute. It has been used for

100 years. We have other toxins in our environment. That is why

I told you about my own experiences today.

FDA, the Food and Drug Administration, would not want to do

its own assessment because it has been used for 100 years?

Here, a case is right in front of you, and I had to go out of this

country to get the mercury amalgam removed. When I did, it

changed my whole physical and emotional being when I got that

mercury ingredient that is in the amalgam out of my mouth.

37

Do you say to me that you haven’t had enough cases and therefore after 100 years of use that you don’t feel the need to say to

an adult, you know you have a choice?

You have a choice. You can take an amalgam that has mercury

in it. You know silver amalgam is 50 percent mercury.

Yes, amalgam is 50 percent mercury. Maybe this is a new fact

that you don’t know. You can check it.

Mr. ALDERSON. I agree with the last statement.

Ms. WATSON. Yes, and so if there are 34 tons of mercury that

come through the system in a dental office and they go out to the

ocean.

Now I am from California, Los Angeles. There is a warning on

the radio, on TV and in the newspaper, do not eat tuna off the

coast of Southern California because the tuna fish has a high mercury level. Pregnant women do not eat tuna. Lactating mothers do

not eat tuna.

So why would we not want to warn a parent when they take

their child in that there is mercury in the filling, but there are options for you? I just can’t understand how the Environmental Protection Agency and the Food and Drug Agency would not want to

after 100 years.

I can get you people right now who have had a very negative reaction and didn’t even understand until they were tested that mercury vapors were emanating from the fillings.

Mr. KUCINICH. The gentlelady’s time is expired. I would like to

come back to you, though. I am going to proceed with questions,

then turn it over to Mr. Burton, and we are going to try to see if

we can get through this round.

Mr. King, of the 1,200 tons of mercury in people’s teeth, where

would that mercury go when these individuals die?

Mr. KING. Where does the mercury go in terms of the diet?

Mr. KUCINICH. Yes, when someone dies, when someone passes

away. We have all this mercury in people’s teeth. So, mercury is

in their teeth. They die. What happens?

Mr. KING. Mr. Chairman, I don’t have specific information on

that.

Mr. KUCINICH. Oh, you could figure this out now. I mean some

people are buried, goes in the ground and others are cremated.

Mr. KING. I understand that, sir.

Mr. KUCINICH. Now if some people are cremated, where does the

mercury go?

Mr. KING. If they are incinerated, the mercury is emitted into the

air.

Mr. KUCINICH. OK. What is the EPA’s estimate for the mercury

emissions throughout the crematoria?

Mr. KING. I believe it is about 0.3 tons.

Mr. KUCINICH. That is correct.

How confident is EPA in that number?

Mr. KING. EPA, at the moment, believes that is an appropriate

number. We are completely open to additional data and would be

happy to sit down with folks who have that data and research.

Mr. KUCINICH. You are correct as far as the EPA’s estimate, but

I want to point out that an EPA environmental scientist recently

published an article in the Journal of Industrial Ecology that estiVerDate 11-MAY-2000 11:32 Jun 05, 2009 Jkt 000000 PO 00000 Frm 00041 Fmt 6633 Sfmt 6633 U:\DOCS\49626.TXT KATIE PsN: KATIE
38

mated that the actual mercury emission from crematoria are 10

times EPA’s official estimate. In other words, they are saying not

the EPA’s estimate of 0.3 tons but 3 tons per year.

Are you familiar with that estimate?

Mr. KING. I am familiar with that. I am familiar with the fact

that scientist used a different methodology, different assumptions,

different factors, and I think our perspective would be to sit down,

compare the two methodologies and to try to come up with the best

information we can around that.

Mr. KUCINICH. Have you done that already?

Mr. KING. I have spoken with the gentleman over the phone.

Mr. KUCINICH. But I mean have you tried to recalculate your

own numbers because he has one estimates and you have one estimate? They are both estimates.

Mr. KING. Our focus, Mr. Chairman, is to reduce mercury emissions to the environment. That is our mission, and that is why in

the air program we focused on the largest emission, contributors of

emissions in the country, and that is why under the water program

we focused so heavily on water quality standards that in turn drive

municipal waste treatment plants in terms of their relations with

dental offices and drive reductions in mercury amalgam.

Mr. KUCINICH. Now, Mr. King, I have information here that says

that the EPA’s estimate derives from one test at one crematorium

at Woodlawn Cemetery in Bronx, New York, in 1993. Is that correct?

Mr. KING. That is correct.

Mr. KUCINICH. But the EPA doesn’t really know how much mercury is emitted from crematoria generally, does it?

Mr. KING. Its current estimate is 0.3 tons. I am fully aware and

recognize and accept—in fact, I have spoken to the gentleman at

some length—of the additional information that you just shared.

Mr. KUCINICH. OK, now when you add EPA’s questionable—I

will use that word—estimate of mercury emissions from sludge incinerators, mercury dental amalgam production and from

crematoria, you get yearly emissions that can range upwards of 1.5

tons per year, but in our next panel we have witnesses that are

prepared to say that the range could be as high as 7 to more than

9 tons per year. That is a pretty large discrepancy, isn’t it, Mr.

King?

Mr. KING. It is new science. It is new information. We would welcome the opportunity to sit down and take a look at what they are

basing their estimates on and work with them directly.

Mr. KUCINICH. Now either dental mercury is relatively small

amount of mercury contamination in the environment or it is a significant amount of mercury contamination of the environment. EPA

is supposed to be able to make distinctions like this with a high

degree of confidence.

What I am asking you is how can you be confident that the size

of the problem is small when the estimates you use are shaky?

Mr. KING. Mr. Chairman, we regard mercury emissions from

dental amalgam as important, and we regard them as important in

terms of following up. Our focus under the air program is to again

by focusing on the largest contributors of mercury emissions, and

39

in this case we respectfully do not believe that crematoria emissions are the largest contributors across the country.

Mr. KUCINICH. But we are really talking about overall the environmental pollution caused by dental use of mercury, and you have

testified, if I am correct, that it is a small amount.

Mr. KING. I testified, Mr. Chairman, that we believe it is small

in proportion to the total number of mercury emissions in the country. Again, the EPA strategy is to attempt to reduce the maximum

amount of emissions that it possibly can, and we do that by focusing on the largest contributors of mercury emissions.

Mr. KUCINICH. You are trying to help us, I know, but you really

don’t know is what you are telling us. When you say small, I am

looking back at the estimate that you have used where you estimate 34 tons of mercury from dental offices.

Mr. Burton.

Mr. BURTON. Mr. Chairman, we have another panel, so I am just

going to ask two real quick questions. I am sure that will be a relief to you gentlemen.

Dr. Alderson, you are a veterinarian?

Mr. ALDERSON. No, sir.

Mr. BURTON. You are not?

Mr. ALDERSON. No, sir. Ph.D.

Mr. BURTON. Oh, Ph.D., OK. Well, then I was misinformed. I

thought you worked in veterinary medicine.

Mr. ALDERSON. I did work in the Center for Vet Medicine most

of my career at FDA.

Mr. BURTON. You worked where?

Mr. ALDERSON. At the Center for Vet Medicine.

Mr. BURTON. Oh, I see. Well, did you know that they used to put

mercury into a substance that was put on horses’ legs to make

them feel better and make them work better?

Mr. ALDERSON. I am aware of that.

Mr. BURTON. Why do you think they took it out of that liniment?

Mr. ALDERSON. The fact of that case is that product was removed

from the market because it was not an approved new animal drug

application not because it was a product containing mercury.

Mr. BURTON. Oh, OK. Well, that is good to know.

My second question is for both of you. Do you think it would be

better if we took mercury out of all vaccines and all substances

that go in the human body? Do you think it would be better?

Mr. ALDERSON. I think from an overall perspective, looking at

what we know about mercury, yes. In the overall concept of mercury, yes. But in terms of making that decision, we still should be

relying on the best science to make that decision. [Laughter.]

Mr. BURTON. Oh, my gosh. I don’t have any more questions.

Mr. KUCINICH. The Chair and the gavel will pass briefly to the

distinguished gentlewoman from California. We are going to go

vote. We will be back. Thank you.

Ms. WATSON [presiding]. This is such an important hearing because I have dedicated decades of my life on this.

I am just being made aware that we have three votes on the

floor, and no one wants to miss three votes. But let me just state

my concern and you can think about it. We will run and vote and

be back.

40

I want to know why the FDA did not do an environmental impact statement when you proposed to classify mercury dental amalgam in the year 2007, Dr. Alderson and Mr. King, if you might

know.

Mr. ALDERSON. I think you mean in 2002.

Ms. WATSON. Excuse me. I am still reeling from that bout I had

with the fumes. 2002, yes.

Mr. ALDERSON. Under our NEPA regulations, those regulations

provide for declassification actions that we do not have to do either

an environmental assessment or an environmental impact statement based on that action. Keep in mind that the regs cover the

action, in this case, the reclassification, not the product in question.

Ms. WATSON. OK.

Mr. ALDERSON. Unless there are actions as a result of that declassification, unless there is something that brings on a finding of

extraordinary circumstances that the environment is going to be affected, then those regulations provide for a categorical exemption.

Ms. WATSON. Dr. Alderson, I think your legal counsel has misinformed you about the Agency’s NEPA obligations.

In written testimony from the former NEPA Director of the

White House Council on Environmental Quality, we learned that:

‘‘It seems clear that the FDA cannot categorically state there is no

significant impact of the rulemaking at hand.’’

‘‘How do they know? They have not completed a comprehensive’’—a comprehensive—‘‘environmental assessment of which I am

aware and the literature and experience would not bear out that

there is inherently no significant effect.

‘‘At a minimum, there is some scientific disagreement on this

point and that alone would be enough to preclude a categorical exclusion.’’

Has the FDA ever done an environmental assessment of the use

of dental mercury amalgam?

Mr. ALDERSON. No.

Ms. WATSON. Dr. Alderson.

Mr. ALDERSON. No.

Ms. WATSON. OK, all right.

Mr. Clark goes on to testify, and it says, ‘‘It seems to me that

such an assessment could help clear up some of the potential impacts or the scientific uncertainty.

‘‘Although FDA and the agencies have reviewed the potential

risk of the use of dental amalgam in humans, it is not clear that

they have taken a look at the risk associated with the use of dental

amalgam and its fate as it moves through the human and natural

environment in water, in air and in soil.’’

That is precisely the type of policy that the authors of NEPA

thought should be subjected to the rigors of analysis.

I would think that there is enough concern that the FDA of all

agencies, would probably want to do and have their own scientific

base, Mr. King. So I am also troubled by your use of the standard,

reasonably foreseeable, because I think your legal counsel has

made a grave error.

You know that mercury is a persistent bioaccumulative toxin.

Would you agree to that? Bioaccumulative, it means it accumulates.

41

Mr. ALDERSON. I understand. I think, conceptually, I agree with

you.

Ms. WATSON. OK. Now the language of the FDA regulation reads

‘‘Thus, classes of actions that individually or accumulatively do not

significantly effect the quality of the human environment ordinarily

are excluded from the requirement to prepare an EA or EIS.’’

Now you have testified that an environmental impact wasn’t reasonably foreseeable, and that reasonably foreseeable standard is

language appearing in the CEQ regulation at 1508.7, defining a cumulative impact. I will just read it to you.

‘‘Cumulative impact is the impact on the environment which results from the incremental impact of the action when added to

other past, present and reasonably foreseeable future actions regardless of what agency or person undertakes other actions.’’

Now, in light of mercury’s inherent characteristics, it is bioaccumulative. In the language of the CEQ regulation on cumulative

impact, how could FDA not reasonably foresee that mercury would

accumulate in the environment from dental offices and their continued use of mercury and not have a cumulative impact?

So, Dr. Alderson, you need to do an analysis to conclude that

there is no significant effect, and FDA hasn’t done one yet. I would

think with our concern that maybe you can get a hint that you

should do it. Do you feel that way?

Mr. ALDERSON. Ms. Watson, to the 2002 proposed rule, we received over 750 comments. The comments to the 2006 meeting

which you testified at, we received over 3,500 comments. FDA is

currently reviewing all those comments and input we received from

those two actions.

If we determine under the regulations that the actions we propose to take as a result of that work results in extraordinary circumstances, per our regulations on categorical exemptions, we be

looking at doing an environmental assessment. But at this point in

time, we have not reached a point to determine what action we will

be taking on dental amalgams.

Ms. WATSON. If we are adding 34 to 54 tons of mercury into the

environment, into the water per year, wouldn’t you want to know

what the effect would be, what the environmental impact would be?

Because of this hearing, would you want to take a closer look and

a have a scientific base on which to come in front of the committee

again and say there is really no significant impact?

Mr. ALDERSON. I agree with you, Ms. Watson. I think as we move

forward in determining the actions we will be taking, this will be

a consideration that we will be making.

Ms. WATSON. I am told that an environmental impact statement

is intended to influence an agency’s decisionmaking process, and already Section 1505.1 of the regulations states this: ‘‘Agencies shall

adopt procedures.’’

I am talking real slowly because I am trying to get my point

across.

‘‘Agencies shall adopt procedures to ensure that decisions are

made in accordance with the policies and purposes of the National

Environmental Policy Act. Such procedures shall include but not be

limited to requiring that the alternatives considered by the decisionmaker.’’

42

Now, Dr. Anderson, by alternatives, the regulation means in part

alternatives to using mercury dental fillings. The whole idea behind NEPA is to force agencies to consider alternatives even if they

don’t want to do so.

Let me just ask you, are there alternatives to mercury dental fillings, Dr. Alderson?

Mr. ALDERSON. There are.

Ms. WATSON. Do they work safely and effectively in your opinion?

Mr. ALDERSON. The ones that we have approved at FDA, yes, I

would agree with that.

Ms. WATSON. Do they contain mercury?

Mr. ALDERSON. No.

Ms. WATSON. Viewed strictly from an environmental impact lens,

Dr. Alderson, which is likely to have a greater environmental impact, 34 to 54 tons of mercury per year or the alternative fillings?

Mr. ALDERSON. If you automatically assume that all of that gets

into the environment.

Ms. WATSON. Wait a minute. Wait a minute. We have this statistic, and you need to go and look it up, that there are between 34

and 54 tons of mercury per year in mercury dental amalgam used

by dentists, and then we are finding that it has affected the sea

life in the ocean to the point that we are announcing to human

beings, don’t eat tuna because of its high mercury content.

It would seem to me a man with a scientific background would

want to look into this and be able to say to us, scientifically, with

an empirical base that we find that tonnage of mercury has not affected seafood or humans. I would think that this is something that

FDA ought to do to minimize environmental harm. Would you

agree?

Mr. ALDERSON. I think it is a purpose of everything we do.

Ms. WATSON. Would you agree that an assessment really is needed to reduce any kind of environmental harm?

Mr. ALDERSON. FDA is looking at the actions that——

Ms. WATSON. Would you agree, yes or no?

Mr. ALDERSON. I think, conceptually, yes, that is always the

basis.

Ms. WATSON. All right, all right. Can I then get the two of you

to agree an assessment is needed ASAP?

Mr. ALDERSON. I can’t agree to that at this point in time. We

have not completed our assessment of what action we will take and

based on the NEPA regulations. Only in the finding of extraordinary circumstances——

Ms. WATSON. Why is there so much resistance to it? Can you,

Mr. King? Can you, Dr. Alderson?

If you know mercury is toxic, if they are taking it out of thermometers, if we closed two schools because there was a mercury

spill, why are you resisting taking a look at mercury that is used

in the human body and doing an assessment?

Can you explain that to me?

Mr. ALDERSON. I don’t think I am going to give you an answer

you will like, but.

Ms. WATSON. No. You give me yours.

Listen, you don’t have to give me an answer I like. I wouldn’t be

up here asking if I had liked anything you have done thus far. So

43

it is time for you to give me an answer and remember, we seek the

truth in this committee.

Mr. ALDERSON. Ms. Watson.

Ms. WATSON. Wait a minute. You need to understand where I am

coming from. I intend to clean our environment so that we can

have healthy lives out there. We know there is a toxic substance

in this casing called amalgam, and I would like the agency responsible for checking out drugs and food to at least be willing to do

an assessment.

Now, respond.

Mr. ALDERSON. The Agency and other public health

organizations——

Ms. WATSON. No. I want to talk about FDA. Talk about FDA.

Isn’t that where you are?

Mr. ALDERSON. That is correct.

Ms. WATSON. OK, let’s talk about FDA.

Mr. ALDERSON. FDA has had numerous advisory committee

meetings on this issue for a number of years, and the last one you

attended in 2006. In none of those meetings, none of them, have

those advisory panels of the best scientists we can bring to bear on

this issue ever advised us that we need to be doing the action and

taking action in terms of either environmental assessment or

changing the way we regulate it.

The last meeting, we did receive some comments about some

changes they recommended, and those are under review at the

Agency.

Ms. WATSON. Dr. Alderson, I want to draw your attention to

what appears to be a logical inconsistency in the 2002 proposed

regulations concerning mercury dental amalgam. As I have already

noted, FDA asserted that classifying the device called dental mercury amalgam would have no environmental impact. However, elsewhere in the proposed regulation, FDA acknowledged that the

presence of mercury in the environment would add to the mercury

burden on individuals and might make some individuals more sensitive to adverse health effects from mercury fillings put in their

mouth.

FDA states: ‘‘Mercury is absorbed from many sources including

food and air. Because of the variability of exposures to mercury

from all sources in the population, the margin of safety for some

persons may be lowered when mercury from amalgam fillings is

added.’’

How could FDA acknowledge mercury pollution on one hand and

suggest the possibility that they might have a human health effect

for certain individuals while, on the other hand, FDA denied any

environmental impact when it applied the categorical exclusion?

I am wondering what the effect might be if you did an environmental impact statement on the effect of that 34 to 54 tons of mercury per year into the water table, into the ocean. So maybe you

can explain to me why there is so much resistance from FDA to do

an environmental assessment.

Mr. ALDERSON. I don’t detect there is resistance to it, Ms. Watson.

Ms. WATSON. Would you do it?

Mr. ALDERSON. I can’t answer that today.

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Ms. WATSON. You cannot?

Mr. ALDERSON. If we follow our regulations.

Ms. WATSON. Wait a minute. You cannot?

You cannot answer that today because I can go back to the law

with you and I can tell you that you probably ought to look at it.

Section 102 of the National Environmental Policy Act of NEPA

says, all agencies, that is all agencies of the Federal Government,

shall—not you may, it says shall—include in any every recommendation or report on proposals for legislation and other major

Federal actions significantly effecting the quality of the human environment a detailed statement by the responsive official on, one,

the environmental impact, the environmental impact of the proposed action and, two, any adverse environmental effects which

cannot be avoided should the proposal be implemented and, three,

alternatives to the proposed action.

I have a bill that I have had for several years now that would

restrict the use of mercury in mercury amalgam in lactating

women, pregnant women and children under the age 18.

I would think that, from what I just read to you and all of that

combined, means that prior issuing of a device classification for a

mercury-containing device, you shall, you shall consider the consequences to the environment of the use of mercury. So I would

think you could make your decision.

If you don’t know what the impact is, then I think you ought to

do an assessment. Do you want to respond?

Mr. ALDERSON. As only then to say that as we are considering

any action that we will take as a result of the comments we received in the last 2 years, 3 years.

Ms. WATSON. Why don’t you do your own assessment?

Mr. ALDERSON. In our view, Ms. Watson, under our regulations,

there is not a requirement at this point to do one.

Ms. WATSON. I am told that you cannot be in violation of this

regulation. It says you shall. You shall. That means you are mandated. Are you going to say to me there is no mandate there?

Mr. ALDERSON. No, ma’am, I am not, obviously.

Ms. WATSON. Well, I am repeating from the regulation. You shall

consider the consequences to the environment.

Mr. ALDERSON. I will assure you we will go back to our legal staff

and define this discrepancy you have identified to us in the law

versus what is in our regulation. Our regulation provides for——

Ms. WATSON. OK. Why are you resisting doing an assessment,

FDA?

Mr. ALDERSON. I don’t know that anyone is resisting.

Ms. WATSON. You are.

Mr. ALDERSON. No. No, I am not, Ms. Watson.

Ms. WATSON. Will you do an assessment?

Mr. ALDERSON. I can’t give you. I am not going to give you an

answer on that. I don’t know the answer.

Ms. WATSON. Will you follow the law?

Mr. ALDERSON. We will follow the law.

Ms. WATSON. Will you reread that section?

Mr. ALDERSON. Absolutely.

Ms. WATSON. And interpret it.

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You know what? Do we have the section on hand? I wish we had

it up on the monitor because I would like you to look at it now and

say to me that you are not going to do an assessment because there

is no requirement.

Can someone get him that information?

Yes, we need to put that on the record. We really do.

Were they sworn in?

STAFF. Yes.

Ms. WATSON. OK. You are under oath now.

Mr. ALDERSON. I understand.

Ms. WATSON. OK. Can the Agency give me the interpretation? Do

you have an attorney with you that can give us an interpretation?

Mr. ALDERSON. I do not have an attorney here today.

Ms. WATSON. OK.

Mr. ALDERSON. We will be glad. As I said, we will be glad to go

back and give you our interpretation of our regs versus the law you

are reading.

Ms. WATSON. Now I am going to read again to you, and I am

being as clear as I can. Section 102, Section 102, somebody needs

to take a note for you, of the National Environmental Policy Act.

NEPA says: All agencies of the Federal Government shall—that

is a mandate—shall include in every recommendation or report on

proposals for legislation—that is what is in front of us—and other

major Federal actions significantly affecting the quality, significantly affecting the quality of the human environment a detailed

statement by the responsible official.

I guess you would be the one. Are you the responsible official?

Mr. ALDERSON. In this case, no. That assessment would be done

at our Center for Devices and Radiological Health.

Ms. WATSON. Well, it would include in every recommendation,

OK, the environmental impact of the proposed action, any adverse

environmental effect which cannot be avoided should the proposal

be implemented and alternatives to the proposed action.

If the World Health Organization concluded that mercury should

be taken out of thermometers, and I think you are aware of that,

why would you want to put it into an amalgam that goes into

someone’s mouth? Do you want to answer that or try?

Mr. ALDERSON. The only answer I have to you, Ms. Watson, is

that again in numerous advisory panel meetings of the best scientists we can bring on this issue, no one has told us to remove

it, no one.

Ms. WATSON. I probably should be on that floor now, but this is

too important.

Mr. King, all that the EPA has done about dental amalgam is

a voluntary education outreach program for young dentists, what

you call the gray bag program. Can you describe the gray bag program, Mr. King?

Mr. KING. Ms. Watson, I can briefly describe it. I would also like

to add, however, we respectfully disagree that all we have done is

voluntary, and I would be pleased to explain why we think we have

done substantially more than that to reduce.

Ms. WATSON. What have you done? You want to tell us what you

have done?

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Mr. KING. I would be delighted to. In the Clean Air Program, the

Agency has reduced emissions by 90 percent for medical waste incineration from municipal combustion. We are on track to reduce

emissions by 70 percent, mercury emissions from coal-fired utility

plants.

In the water arena, we have put into place, working directly with

States, water quality standards both in the Great Lakes.

Ms. WATSON. OK, let me stop you there.

Mr. KING. Yes, ma’am.

Ms. WATSON. Can you address mercury amalgam?

Mr. KING. Yes, ma’am. When we establish a water quality standard under the Clean Water Act, States put it into their State

standards and then those affect the discharge that a municipal

wastewater treatment plant can make to waters of the United

States.

Because our standards are so stringent for mercury, what those

standards operate to do is, in essence, force or drive or encourage

a municipal wastewater treatment plant to go back up the sewer

to a number of the mercury dischargers including dental offices

and to work with dental offices to reduce their dental mercury

amalgam discharges to the sewer system.

Duluth, Minnesota was one example that has worked out very

impressively, reducing them by two-thirds.

The city of San Francisco has adopted a goal of putting into place

amalgam separators in 900, all of their dental offices. Those separators have a removal efficiency of mercury amalgam of over 95

percent.

The States in the Great Lakes have established extremely stringent mercury wildlife numbers. Those mercury wildlife numbers

have operated to take six States in the Great Lakes, have them

join together with EPA’s Region 5 office and develop a pollution

prevention reduction plan that goes directly to the reduction in

part of dental mercury amalgam.

Ms. WATSON. Now this is what other States have done, right, and

they have done it on their own, like San Francisco. They have done

it on their one. What has EPA done?

You have a gray bag program, but it is voluntary. You get information out there. What have you done?

Mr. KING. The gray bag program goes the mercury amalgam that

is removed in the dentist’s office and to send it to a recycle.

Ms. WATSON. But it is voluntary, is it not?

Mr. KING. It is voluntary, yes, ma’am.

Ms. WATSON. OK. Now how many dental students have actually

gone through your seminar up at Marquette University?

Mr. KING. Forgive me. Would you please repeat that? I apologize.

Ms. WATSON. Sure.

Mr. KING. How many dental students have gone through my

seminar?

Ms. WATSON. Yes.

Mr. KING. I have not actually provided a seminar to dental students, but we have a great deal of outreach.

Ms. WATSON. It is an initiative that you are trying to develop?

Mr. KING. If you are referring to gray bags.

Ms. WATSON. I am talking about mercury amalgam.

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Mr. KING. OK. I thought you were talking about water quality

standards. I don’t have the number on how many dental students

have participated in that program.

Ms. WATSON. In the gray bag program?

Mr. KING. Yes, ma’am. I do not have that number with me right

now. I am sorry. I will be happy to provide it for the record if that

would be useful, OK.

Ms. WATSON. We would like that.

Mr. KING. Yes, ma’am.

Ms. WATSON. If actual air emissions of mercury caused by dental

mercury use is closer to 10 tons per year, do you think that EPA’s

educational gray bag program is sufficient to address a problem of

this magnitude?

Is it enough to give a seminar to dentistry students—it is a seminar—and not have some requirement that maybe we ought to mandate this?

Mr. KING. We think the gray bag program is a very valuable, albeit voluntary, program.

Ms. WATSON. Sure.

Mr. KING. That is only one of a number of things the EPA is

doing to reduce mercury releases to the environment.

Ms. WATSON. What else are you doing? I would like to stick on

mercury amalgam for a minute.

Mr. KING. You bet. We are focusing on working with municipal

wastewater treatment systems to encourage them and provide

them with guidance so that they, in turn——

Ms. WATSON. Let me ask you this directly.

Mr. KING. Yes, ma’am.

Ms. WATSON. Would you want to encourage the industry not to

use mercury in amalgams?

Mr. KING. The use of mercury in amalgams is an area that falls

within the purview of the FDA. Our focus at EPA is to address the

release of mercury emissions into the environment, and we believe

we have a number of substantial and effective regulations and programs in place to substantially reduce the release of those emissions.

We regard——

Ms. WATSON. Would you encourage dentists not to use mercury

in the amalgams? Would you suggest that to your students?

Mr. KING. EPA does encourage.

Ms. WATSON. No. I am talking about you. You hold this seminar,

am I correct?

Mr. KING. Yes, ma’am. Yes, ma’am.

Ms. WATSON. Is it you or EPA that holds that seminar?

Mr. KING. EPA conducts the seminar. It is a program that is not

the program that I run, but I have spoken to that program and I

know that they encourage the use of non-mercury amalgam. However, EPA is very clear in the importance of ultimately deferring

to dental professionals and their patients on the most appropriate

amalgam to suit their situation.

Ms. WATSON. I am being told that we have a major bill now up

for a vote. I have missed all the votes leading up to it, but this is

on the actual bill. So I am going to have to recess this panel, and

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I want to thank you two gentlemen for being patient, for testifying

and for hearing.

I am strongly suggesting that if we have a problem with a toxic,

and I am passionately committed to this, the removal, if we could

remove that toxic, it would be one less impact on the human body.

We are dealing with lead in children’s toys, toys that were manufactured over in China with different standards. We are dealing

with the runoff from the dental offices into the ocean where we are

warning people not to eat tuna. We know asbestos was out there

in building materials.

We have all these impacts. We are trying to clean up our environment. If I trust FDA, I would think this hearing would be very

valuable to you if you are committed to keeping people safe.

With that, I want to thank you so much for your patience. We

will dismiss the first panel. We will take a short recess, and we

will bring up panel two. Thank you, gentlemen.

Mr. KING. Thank you.

[Recess.]

Mr. KUCINICH [presiding]. The committee will come to order.

I want to thank the witnesses for their patience. I think what I

will do is I am going to introduce the witnesses and then we will

swear or affirm their presence and their testimony.

Unfortunately, one of the witnesses that we had hoped to have

here, Mr. Bruce Terris, had a last minute conflict. He will be submitting his testimony for the record.

Mr. Ray Clark, welcome. Mr. Clark is a senior partner in The

Clark Group, LLC and was the National Environmental Policy Act

Director at the White House Council on Environmental Quality

from 1993 to 1995. He served as Associate Director of CEQ from

1995 to May 1999. He has also served as Principal Deputy Assistant to the Secretary of the Army with responsibility over environmental program management in millions of acres of DOD-owned

land.

Second, we will hear from Michael Bender who is the Founder

and Director of the Mercury Policy Project. The project works to

promote policies to reduce and eliminate uses, releases and exposures to mercury at the local, national and international levels.

Mr. Bender has participated on a steering committee for the

International Conference on Mercury as a Global Pollutant, as a

member of the U.S. Federal Stakeholder Group on Surplus Mercury and is Co-Chair of the State of Vermont Advisory Committee

on Mercury Pollution.

Dr. C. Mark Smith is the Deputy Director of the Office of Research and Standards of the Massachusetts Department of Environmental Protection and directs the agency’s multimedia mercury

program. His areas of expertise include toxicology, risk assessment

and environmental policy particularly related to toxic chemicals

such as mercury. He holds a Ph.D. in the fields of molecular and

cellular toxicology and a Master’s degree in environmental management from Harvard University.

Dr. Smith currently co-chairs the New England Governors and

Eastern Canadian Premiers Regional Mercury Taskforce among

other roles.

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Finally, Dr. J. Rodway Mackert, he is a dentist and professor at

the Medical College of Georgia and is representing the American

Dental Association today. He has advanced degrees in dentistry

and in materials science.

Gentlemen, it is the policy of the Committee on Oversight and

Government Reform to swear in all witnesses before they testify.

Whenever a witness says that they do not take such oaths, we ask

them to proceed with an affirmation that this is their testimony.

So whether you swear or you affirm, I would ask you to rise right

now and answer this question.

[Witnesses sworn.]

Mr. KUCINICH. Thank you. Let the record reflect that our witnesses answered in the affirmative.

As with the first panel, I ask that the witnesses give an oral

summary of your testimony and to keep this summary under 5

minutes in duration, although if you go a little bit more—you have

been very patient, waiting for us—we will hear you out, but try to

keep it under 5 minutes.

Bear in mind your complete written statement will be included

in the hearing record.

Now in the interest of expediting Mr. Clark’s schedule, you may

proceed, and then we will go right down the row. Mr. Clark.

STATEMENTS OF RAY CLARK, SENIOR PARTNER, THE CLARK

GROUP, LLC; MICHAEL T. BENDER, EXECUTIVE DIRECTOR,

MERCURY POLICY PROJECT; DR. C. MARK SMITH, CO-CHAIR,

MERCURY TASKFORCE, NEW ENGLAND GOVERNORS’ CONFERENCE; AND DR. J. RODWAY MACKERT, DENTIST AND

FACULTY MEMBER, MEDICAL COLLEGE OF GEORGIA

STATEMENT OF RAY CLARK

Mr. CLARK. Good afternoon, Mr. Chairman and members of the

subcommittee. It is a real pleasure to be before the Domestic Policy

Subcommittee on an important and very timely issue of classification of dental amalgam, dental mercury amalgam and the Food and

Drug Administration’s responsibility under the provisions of the

National Environmental Policy Act.

Allow me a brief moment to provide you my background. I am

a senior partner with The Clark Group, a Washington, DC-based

environmental and energy consulting firm. I left public service in

2001 as the Principal Deputy Assistant Secretary of the Army, and

from 1992 to 1999 I served in the Council of Environmental Quality in the Executive Office of the President.

I have been teaching NEPA implementation at Duke University

since 1989, and I am the editor of a book on the history and the

passage of NEPA, the current principals and practice and the future of the statute and its practice.

When Congress passed NEPA in 1969, they recognized the complexity of environmental issues and the role of the Federal Government in the perturbations and improvement in the human environment. Congress also recognized it was not only the direct effects

agencies may have but the many polices, regulatory actions and the

effects on markets.

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NEPA provides the Nation with an environmental policy, a tool

to reach that policy and an agency within the Executive Office of

the President to ensure that the agencies understand the policy in

Section 101 of the statute and develop and oversee the development

of procedures to comply with the law.

With the passage of NEPA, Congress established the Council on

Environmental Quality and directed the Federal agencies to work

with governments at all levels to begin the arduous task of understanding the effects of manifold actions taken in the absence of full

information.

No statute has offered a more structured and disciplined approach to Federal decisionmaking, and no statute has offered the

public as transparent a window into Federal decisionmaking as

NEPA. No statute has given the agencies more flexibility to establish the ways and means of meeting that mandate.

Since the passage of NEPA, Congress, CEQ and the courts have

responded to the uncertainties of human experimentation on the

natural landscape through statutes, regulations and court decisions. All have given great deference to the agencies, but they have

all asked the agencies to take a hard look at proposed actions to

try to ascertain the direct, indirect and cumulative effect of such

actions.

Over the course of time and with the help of NEPA and the agencies’ hard look, we now know more about the effects of many Federal actions, whether they be policies, projects or programs. We

also know more about how complex environmental interactions are.

We also understand that our collective environmental knowledge

gap is wide.

Through the work of the FDA, the Environmental Protection

Agency and other public and private science, we now know that

mercury is a highly toxic, persistent and bioaccumulative

neurotoxin.

We now know that it is released in the air through the burning

of coal at power plants and the burning of mercury-containing

wastes. It is released into water either directly or indirectly by deposition or to wastewater treatment plants or in the sludge treated

at those plants.

In my opinion, it seems clear that at least one of the two following conditions exists: one, there is a clear environmental effect of

the manner in which mercury amalgam is being treated and disposed; or, two, there are scientific uncertainties about the extent of

the environmental effects.

Any statement that there is no environmental effect would be

met with argument and likely scientific controversy as we see

today. In either situation, however, there is a responsibility of the

Food and Drug Administration to understand these effects or the

differing scientific views before making a decision. NEPA requires

such an understanding before FDA can make a decision on risk

classification.

In order to categorically exclude such an action as was suggested

today, as a rulemaking on classifying dental mercury amalgam, the

FDA would have to reach one of two possible conclusions: either

the mercury amalgam inherently has no significant impact or cumulative environmental effect, or through the experience of numerVerDate 11-MAY-2000 11:32 Jun 05, 2009 Jkt 000000 PO 00000 Frm 00054 Fmt 6633 Sfmt 6633 U:\DOCS\49626.TXT KATIE PsN: KATIE
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ous environmental impact analyses, they have consistently found

that there is no significant impact.

It seems clear that FDA cannot categorically state that there is

no significant impact of the rulemaking at hand. How do they

know? They have not completed a comprehensive environmental

assessment of which I am aware, and the literature and experience

would not bear out that there inherently is no significant effect.

At a minimum, there is some scientific disagreement on this

point, and that alone would be enough to preclude a categorical exclusion. There are uncertainties associated with the use of dental

amalgam such as the amount discharged from dental offices, the

fate of mercury in amalgam and the percentage of elemental mercury that is released from amalgam.

There are also others in State and local government taking precautions to assure safety, and that should clearly indicate to the

FDA that the effects of the rule are not ‘‘inherently insignificant.’’

The second way FDA could categorically conclude there are no

significant effects is by preparing one or more environmental assessments, each of which reaching a finding of no significant impact.

In fact, in 1997, FDA responded to a question about whether secondary or tertiary manufacturing processes involving food additives

that may result in uncontrolled end products should be categorically excluded. The Agency responded appropriately, in my opinion,

because they reviewed hundreds of environmental assessments

that contained information regarding manufacturing sites and

found no significant impact, that they decided to categorically exclude the process from further analysis, and I believe that is the

appropriate way you come to the conclusion of a categorical exclusion.

To my knowledge, no comprehensive environmental assessment

has been prepared on the issue of dental mercury amalgam. It

seems to me that such an assessment could clear up some of the

potential impacts of scientific uncertainty. Although FDA and the

agencies have reviewed the potential risks of the use of dental

amalgam in humans, it is not clear that they have a taken a hard

look at the risks associated with the use of dental amalgam and

its fate as it moves through the human and natural environment

in water, air and soil.

The mercury discharged by dental offices may fall within the

purview of many agencies, each approaching the problem through

its particular regulatory lens. Each agency can move the mercury

to a different media and different set of regulations without removing it from the environment, as we saw today with our two witnesses moving the mercury amalgam from one agency to another.

No one agency addresses the cumulative long term effects of mercury discharges, and there is no assurance that the mercury is ever

effectively sequestered.

FDA may be right, that the environmental effects associated with

the level of use is not significant. However, I cannot see how they

have come to the conclusion. They have not produced any environmental assessment or impact statement, and the literature and

practice is rife with questions about the use and disposal.

52

It is precisely the type of policy that the authors of NEPA

thought should be subjected to the rigors of analysis. The rulemaking action clearly is a significant action anticipated by NEPA.

CEQ regulations define a major Federal action as ‘‘actions with

effects that may be major and which are potentially subject to Federal control and responsibility.’’

Actions also include the ‘‘circumstance where the responsible officials fail to act and that failure to act is reviewable by courts or

administrative tribunals under the Administrative Procedures Act.’’

Further quoting from the CEQ regulations defining a major Federal action: ‘‘Actions include new and continuing activities, including projects and programs entirely or partly financed, assisted, conducted, regulated or approved by Federal agencies; new or revised

agency rules, regulations, plans, policies or procedures; and legislative proposals.’’

Mr. Chairman, there are ways such an assessment could be done

efficiently and effectively. FDA could prepare a programmatic environmental assessment. If indeed the Agency could answer the questions being posed by sewage plants, by cities and counties and by

health officials, perhaps many resources could be saved by those

authorities.

Perhaps, FDA could identify mitigation techniques that would

render the impacts insignificant. Perhaps a collaboration between

FDA and other Federal, State and tribal governments would

emerge and programmatic approaches could be developed.

A forward-looking FDA in 1978, Mr. Chairman, filed a programmatic environmental impact statement regarding the use of

fluorocarbons in products subject to FDA regulation. The EIS was

used as a basis for prohibiting chlorofluorocarbons as a propellant

in self-pressurized containers if the use of the CFC was not deemed

to be essential. This action seems all the more responsible in hindsight.

In conclusion, Mr. Chairman, there is much to commend in the

FDA NEPA regulations. There is sound environmental policy.

There is transparency and there is admonition to prepare readable

analyses for the public and solid streamlining efforts which we

should all support.

FDA has, in the past, used EISes for sound decisionmaking.

However, on the question of whether there is sound footing to declare a categorical exclusion for rulemaking for classification of

risks, I do not see a basis.

I would recommend to FDA to prepare a programmatic environmental assessment on the rule and allow the scientific community

and the public to offer their advice and counsel before asking the

decisionmaker to decide in the absence of any environmental impact analysis.

Thank you and I would be pleased to answer questions.

[The prepared statement of Mr. Clark follows:]

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57

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Mr. KUCINICH. Thank you very much, Mr. Clark.

Mr. Bender, you may proceed.

STATEMENT OF MICHAEL T. BENDER

Mr. BENDER. Thank you, Mr. Chair and members of the subcommittee.

I am here today to testify on the environmental risk of mercury

dental fillings. My name is Michael Bender, and I am the Director

of the Mercury Policy Project. The project was formed in 1998 to

reduce mercury uses and releases and exposure to mercury.

Next slide, please.

My presentation today will highlight the following. One, in 1997,

EPA reported to Congress to establish a ‘‘plausible link between

human-polluting activities and mercury levels in the environment.

Dental mercury releases increased the load of mercury to the environment and also human exposures to methylmercury through the

fish that people eat.’’

Two, while most other sectors have eliminated or drastically reduced their use of mercury, dental mercury use and release continues relatively unabated.

Three, the transformation of dental mercury to methylmercury in

wastewater, surface water and soils is supported by a substantial

body of research.

Four, while the ADA and its members appear to favor a voluntary approach, the record clearly shows that control requirements are necessary to reduce mercury pollution and are most costeffective in doing so.

Finally, my presentation will clearly show that mercury air releases from dental uses may be more than five times recent EPA

estimates.

Next slide, please.

As show in the EPA diagram from 2004, dental offices are the

third largest user of mercury.

Next slide.

Over half of all mercury—and we have heard this repeatedly

today—currently in use amounting to over 1,000 tons is in Americans’ mouths according to the second EPA diagram from 2004.

Next slide.

Dental amalgam is by far the largest source of mercury to municipal wastewater treat plants in the United States, and numerous

studies have demonstrated this. Dental mercury contributes more

than three times the mercury than the next largest source. According to even the American Dental Association, dental mercury contributes 50 percent of the load to municipal wastewater streams.

Next slide, please.

Mercury emissions from cremations have nearly doubled in the

past decade and are now over three tons per year and growing. In

the next 15 years, emissions from crematoria are expected to rise

still further.

There are two simultaneous trends contributing to this. First, the

rise in the average number of fillings per person cremated, and this

is because more recent dental healthcare has resulted in the retention of more teeth and more fillings as people age. Second, there

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is a dramatic rise in the number of cremations due to the rising

cost of burials.

Next slide.

Nationwide, about 20 percent of sewage sludge is incinerated in

the United States according to a recent journal article by the EPA

Region 5 official. Based on the extrapolation of the NSCAUM or

Northeast States for Coordinated Air Use Management and States

estimates, dental mercury emissions from sludge incineration are

estimated about two tons per year nationwide.

Next slide.

It is estimated that municipal sewage sludge may release 15 to

18 pounds of mercury per day into the atmosphere, and nearly 1

ton of mercury is estimated to be released each year from land application of sludge.

Next slide, please.

A recent study of mercury discharges from dental offices indicate

that they release about one ton of mercury per year to the air.

Next slide.

In King County, Washington, the resistance of the dental community to installing pollution control equipment contributed to the

length of time and the changing strategies employed by the county.

As you can see from this slide, starting around 2000, there were

a number of educational outreach, so-called voluntary, initiatives

that resulted in a very minimum requirement until 2003, when a

law or a regulation went in place, mandating best management

practices and installation of amalgam separators. This resulted in

97 percent compliance.

I might add that we are not talking about thousands and thou- sands of dollars. We are talking about maybe an average of $100

a month to prevent a dramatic amount of mercury releases to the

environment.

Next slide, please.

Correspondingly, these regulations resulted in significant reductions in mercury concentrations in the sludge, and we have seen

this in Toronto. We have seen this, and Mark Smith will be talking

about the Massachusetts Water Resources Authority. Wherever

amalgam separators and best management practices are put in

place, there are dramatic reductions in pollution.

Next slide, please.

Based on the recognized need for mandating pollution control requirements at dental clinics, these nine States have either passed

laws or regulations requiring these amalgam separators and pollution control equipment. I might add that there are approximately

another 10 States that have proposed similar legislation.

Mr. Chair and members of the committee, that is how we have

been able to effectively promote de facto national legislation over

the last 5 or 6 years.

We have reduced and eliminated mercury uses in the large product categories ranging from mercury switches, relays and measuring devices to the point where 30 to 40 percent of the population

lives in States now that no longer allow sales of mercury-containing products. We are now altering our focus a bit and expanding

it to this collection arena because of the great quantities involved.

Finally, next slide, please.

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This slide is hard to read, but it is really this table, in our extensive written testimony, summarizes and challenges these estimates

by EPA that dental mercury uses only result in 1.5 tons of mercury

air releases each year.

As discussed during this presentation, crematoria are estimated

to release over three tons of mercury emissions in the air each

year. Mercury emissions from sludge incineration are estimated to

add another two tons per year, and another ton per year is added

through direct releases from dental offices and those are air releases.

Combined with other smaller, yet significant releases, we estimate that the dental mercury releases to the air are more than 5

times as much as the EPA estimate of 1.5 tons per year. Our estimates range from a low of 7 to a high of 9.4 tons of mercury released to the air each year from dental uses.

Finally, last slide.

I don’t know if you can read the cartoon, but the woman is saying, with all this mercury in my mouth, I must be an environmental problem.

I think it really goes to the heart of this issue, that we really,

even with all this pollution control equipment, we really can’t stop

this pollution source until we stop using mercury dental fillings.

Thank you and I would be willing to answer any questions.

[The prepared statement of Mr. Bender follows:]

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Mr. KUCINICH. Mr. Smith.

STATEMENT OF C. MARK SMITH

Mr. SMITH. Thank you, Chairman Kucinich and members of the

committee, for inviting me to testify today on the environmental

impacts of dental mercury.

I would like to start by saying that as a scientist, as a father and

as a fisherman, I have been very concerned about mercury pollution and its effects on the environment and our children’s health.

I think it is a real sad state of affairs when we have to tell our

kids that the first keeper fish that they catch they can’t eat because it is too toxic due to mercury contamination, which is something I have had to do with both my daughter and my son over the

past few years. I anticipate that I may end up having to do that

with my grandchildren at the pace we are going with dealing with

some of our mercury issues.

To help address this problem, I have been engaged in mercury

policy and research for the past 15 years. As Chairman Kucinich

mentioned, I currently direct my agency’s mercury reduction strategy.

I have been the Massachusetts representative on the Quicksilver

Caucus, a national multi-State group addressing mercury issues

across the country, and I co-chair the New England Governors and

East Canadian Premiers Mercury Taskforce, and I have done that

for the past 10 years now.

I am speaking on behalf of the New England Governors’ Conference which is a multi-State organization established by the Governors of the New England States to address policy issues of a regional nature including environmental issues like mercury. I am

also representing my agency, the Massachusetts Department of Environmental Protection.

To address the serious impacts of mercury pollution in the northeast region of our country and also in Canada, the New England

Governors and Eastern Canadian Premiers unanimously adopted a

binational regional mercury action plan in 1998.

I think it is notable just to point out that this plan was endorsed

by both U.S. political parties and by, I believe, three different political parties in Canada. I get those a little confused, but I think it

was three different parties north of the border as well. So we had

real multi-partisan support for this particular effort.

This plan called for the virtual elimination of mercury, anthropogenic mercury releases in our region and established interim goals

of a 50 percent reduction by 2003 and a 75 percent reduction by

2010. That is compared to a 1998 baseline.

I am pleased to report that we beat our 2003 goal, achieving over

a 54 percent reduction in regional mercury emissions by that date,

and we are well on our way to hitting the 75 percent reduction target by 2010.

This has been accomplished through the implementation and

adoption of very strict regulations that far exceed Federal U.S.

EPA requirements in pretty much every instance which have resulted in dramatic reductions in mercury emissions from trash incinerators where our regional limits are three times more strict

than EPA requires.

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Coal-fired power plants where cameras targeting a 70 percent reduction which probably will not be achieved until after 2020 because of banking of credits. In Massachusetts, we have a 95 percent control requirement by 2012.

Mercury products, as Michael mentioned, many States including

all of the New England States have laws in place now that are

phasing out many unnecessary uses of mercury, requiring products

to be labeled and remaining products to be recycled, and we are

also addressing the dental sector.

As we have heard, many estimates have concluded that the dental sector, in the absence of the use of amalgam separator pollution

controls, accounts for 50 percent or more of the mercury entering

municipal wastewater where it concentrates into sewage sludge. In

areas where amalgam separators have been required including in

my State, Massachusetts, mercury levels in sludge have decreased

by a lot, typically by around 50 percent.

This is important because mercury discharge from dental offices

is ultimately released to the environment when sewage sludge is

incinerated or when it is land-applied and reused as a fertilizer.

Dental mercury can also be released to the environment in

wastewater treatment plan wastewater discharges, in overflows of

combined sewers where storm events exceed treatment plant capacities, in solid waste if the material is inadvertently or inappropriately disposed of to solid waste streams, and upon the cremation

of individuals with amalgam fillings.

In my area, in the Northeast, sewage sludge incinerators were

estimated to be the third largest source of mercury emissions prior

to amalgam separator requirements in our States, accounting for

about 1,100 pounds of emissions. That is 12 percent of our total regional emissions of mercury in 2003.

It is important to note that this estimate did not include releases

attributable to the reuse of sewage sludge treated biosolids which

would significantly increase the total.

In 1997, land-applied sewage sludge was estimated to release

over 10,000 pounds of mercury per year in the United States and

Europe.

The large surface area of the small amalgam particles typically

released into dental wastewater enhances the mobilization of the

mercury contained in the amalgam in comparison to an intact filling, resulting in its bioavailability for methylation. This conclusion

was supported by numerous experiments including one where mercury levels in fish increased by 200fold after exposure to amalgam

particulates for 28 days.

Amalgam separators are inexpensive technologies that can reduce mercury dental pollution by greater than 95 percent. The

northeast region adopted in 2005 a goal that 75 percent of our region’s dentists that generate amalgam wastes should install amalgam separators by 2007 and 95 percent by 2010.

The national Canada-wide standards also established a 95 percent goal for all of Canada. The northeast region is well on its way

to meeting these goals. Montreal, the first northeast city to mandate separators has reported that mercury levels in their sludge

have been decreased by greater than 50 percent since they required

the separators.

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Overall, in Eastern Canada, more than 50 percent of their dentists and, in New England, more than 78 percent of our dentists

are now using amalgam separators.

In Massachusetts, we have worked collaboratively with our State

and the Massachusetts Dental Society and adopted an MOU in

2001 to encourage amalgam separator use and the use of best management practices. A followup program was initiated a couple of

years later in 2004 when my agency announced that we would be

developing regulations to require separators with an anticipated

adoption date of 2006.

To achieve faster mercury reductions, the agency also initiated a

voluntary early compliance program. We provided some incentives

to the dentists including waiving permit fees that would be required and also grandfathering systems that were installed under

the program that met a 95 percent amalgam removal efficiency.

By the end of the first year, 75 percent of Massachusetts’ dentists certified that they had installed amalgam separators preventing the discharge of many hundreds of pounds of mercury into our

wastewater. Regulations requiring the use of amalgam separators

were ultimately adopted in the spring of 2006.

Data from our largest wastewater treatment plant, the Massachusetts Water Resources Authority which treats sewage for 2.5

million people in the greater Boston area, indicate that our program has been very successful. Over the 2004 to 2006 time period,

when our amalgam separator use increased to over 80 percent in

Massachusetts, mercury levels in MWRA sludge from that treatment plant have decreased by over 48 percent.

In conclusion, the dental sector can be a significant source of

mercury pollution to the environment. Amalgam separators can

significantly reduce such releases. Collaborative initiatives to expand the use of these control technologies, which include quantifiable goals and objectives and meaningful compliance deadlines, are

very effective based on our State experiences and should be pursued nationally.

I would also like to point out that the Northeast States recently

determined that anthropogenic mercury releases will need to be reduced by greater than 86 percent to restore our contaminated

water bodies and make their fish safe to eat. To achieve such reductions, all preventable sources of mercury releases to the environment will need to be addressed.

Thank you again and I am willing to answer any questions that

you may have.

[The prepared statement of Mr. Smith follows:]

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Mr. KUCINICH. Thank you, Mr. Smith.

Dr. Mackert, please proceed. Thank you.

STATEMENT OF J. RODWAY MACKERT

Dr. MACKERT. Thank you, Mr. Chairman and members of the

subcommittee.

My name is Dr. Rod Mackert. I am a dentist and a professor at

the Medical College of Georgia. I am pleased to offer testimony

today on behalf of the American Dental Association.

The ADA is the world’s largest and oldest dental association representing more than 155,000 dentists nationwide. It is our understanding that the focus of this hearing is on amalgam’s impact on

the environment. We are grateful for the opportunity to comment

on this topic.

I don’t want to overlook the obvious, so I will first define what

we are here to discuss. Dental amalgam is an alloy made by combining silver, copper, tin and zinc with mercury. It has been studied and reviewed extensively and, based on the best available

science, dentists continue to rely on it as a safe and effective option

for treating dental decay.

Now, allow me to share our thoughts on amalgam and environmental issues. We are very proud of our efforts to protect the environment. We have developed and implemented best management

practices or BMPs on amalgam waste and are pleased to note that

we recently added the use of amalgam separators to that list.

The ADA actively promotes its BMPs which have had a very

positive impact. As one example, we have virtually eliminated the

use of bulk mercury in dentistry. Dentists now used encapsulated

amalgam, capsules containing a small amount of elemental mercury and the powdered metals with which it is mixed. Because

amalgam is now encapsulated, mercury spills are virtually eliminated in the dental office.

The ADA’s BMPs have also greatly promoted the recycling of

waste amalgam by calling on all dentists who either replace or remove amalgams to use chair-side traps and vacuum pump filters.

These standard control methods remove approximately 77 percent

of the scrap amalgam before it enters the wastewater. The amalgam captured by these devices can then be recycled.

None of this would have been possible without the ADA vigorously promoting its best management practices with dentists

throughout the Nation. We have distributed posters and brochures

explaining the BMPs to every dentist in the Nation, not just to

ADA members. The ADA promotes BMPs on its Web site and offers, in partnership with State dental societies, training programs

for dentists.

In addition, the ADA sponsored the most thorough peer-reviewed

study, which I have here, on the issue of dental office wastewater.

As I mentioned, the ADA this year amended its list of BMPs to

include the use of amalgam separators. We took this action because

we have gained a lot of experience with separator technology and

even assisted the ISO, an international standard-setting organization, in developing standards for the devices.

We have learned that the systems work well, and we now feel

comfortable including them in our best management practice recVerDate 11-MAY-2000 11:32 Jun 05, 2009 Jkt 000000 PO 00000 Frm 00098 Fmt 6633 Sfmt 6633 U:\DOCS\49626.TXT KATIE PsN: KATIE
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ommendations. We are just beginning to promote our revised BMPs

and will make every effort to ensure that every dentist in America

has that information at hand.

Another point to consider is the declining use of dental amalgam.

In 1990, dental amalgams constituted 68 percent of all dental restorations. By 1999, that figure had dropped to 45 percent. Our

most recent estimate is about 30 percent. We expect this trend to

continue. In other words, this is a problem shrinking on its own.

I am proud that the ADA and the Nation’s dentists are taking

these steps voluntarily. We are working to protect the environment

by educating our members, encouraging recycling and promoting

highly effective best management practices. If there are additional

things we can do to improve our BMPs, I am confident that we will

take the necessary steps to do just that.

Dentistry is proud of its efforts to protect the environment just

as we have always protected the health and well being of our patients. We pledge to continue our efforts. We appreciate the opportunity to share this information with you.

Thank you.

[The prepared statement of Dr. Mackert follows:]

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Mr. KUCINICH. Thank you. Thank you very much, Dr. Mackert,

for being here.

To Mr. Clark, in the FDA’s written testimony, they have also

stated that the analysis is determined by the action taken by the

Agency and not the product in question. FDA has no reason to

think that changing the classification of mercury by itself will affect its level of use in a way that would have a significant effect

on the environment.

In other words, FDA is saying that all they are doing is ratifying

what is already the status quo, so no EIS is needed.

Would you comment on the FDA’s interpretation of the National

Environmental Policy Act?

Mr. CLARK. I would be happy to, Mr. Chairman.

FDA is quite right, that the focus of NEPA is the action or, in

other words, the decisions that are at hand. It is still unclear,

though, how they know, what kind of action or what kind of behaviors are going to be generated as a result of their action or their

decision.

It is quite clear that they have some concern about the risk associated with mercury amalgams. They are, in fact, taking some of

the action based on safety concerns, and so it seems to me that the

question remains at hand how do they know.

In fact, it is a status quo. It is status quo because they have been

doing the same thing, but you can’t keep doing the same wrong

thing and saying that we ought to continue doing that.

Mr. KUCINICH. But would it be fair to say that when you take

that view, that the analysis is determined by the action taken by

the Agency and not the product in question, that in a sense can

have a way of rewarding an Agency that doesn’t do an thorough

analysis by being able to say, well, it wasn’t that much of a problem to begin with, so we didn’t have to take that much action?

Mr. CLARK. Well, I listened to the last speaker, and he said two

different things over and over, it seemed to me. One of the things

he said was that yes, he thought some kind of analysis might be

justified, and then he would say but our regulations say that we

don’t have to do it.

And so, I think there is much, much, too much of a reliance on

some kind of legal interpretation that they have made without the

benefit of any analysis ever as far as anyone is concerned.

The major point, I think, is that the cumulative effects analysis

over these years of the status quo, as you say. The status quo

keeps building and mercury keeps accumulating in the environment. The problem doesn’t really get better. The problem gets

worse, and so there ought to be some kind of assessment.

Mr. KUCINICH. I appreciate your involving yourself in this discussion because when I look at this statement, the analysis is determined by the action taken by the Agency and not the product in

question, it seems that they have the cart before the horse here.

If you have a product, you analyze the product. You don’t base

your analysis of the efficacy or the challenge to that product by asserting that if you take action, then there must be something

wrong with the product. There might be some inherent situation

with that, an inherent problem with the product.

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Mr. CLARK. That is right. Their action is changing or establishing

behavior, and those behaviors are subject to the National Environmental Policy Act.

Mr. KUCINICH. I am going to just go to one more question and

then take it to Mr. Burton. But I just want to say, Mr. Burton, that

we heard the gentleman here testifying, representing various agencies, and if they don’t see the extent of the problem and they don’t

quantify it, then what they are basically saying is that, well, we

didn’t have to take any action because we didn’t really see that the

product in question was that ubiquitous in the environment.

I just want to have one more question. They also use a standard,

that is the FDA, that they call reasonably foreseeable as in if it is

not reasonably foreseeable that there would be an increase in the

amount of mercury introduced in the environment that would constitute an extraordinary circumstances, FDA would appropriately

rely on its existing categorical exclusion.

Would you please comment on reasonably foreseeable, that

standard, in complying with the National Environmental Policy

Act?

Mr. CLARK. I, again, think they are quite right to say that CEQ

reg mandates them to look at what is reasonably foreseeable, and

the interesting point is that if they would read the definition of cumulative effect, then they would see that they have to look at what

is reasonably foreseeable, not only what they are doing but what

everybody else is doing in the environment as well.

The CEQ regulation definition of cumulative effect says all past,

present and reasonably foreseeable. That is the context in which

they use reasonably foreseeable, that you have to consider all the

things that have gone before you, all the things that are before you

now, and not only what FDA is putting in the environment with

regard to mercury but what all other entities, and not only Federal,

not only FDA, but all the other Federal agencies and not only all

the Federal agencies but all the other users.

And so, essentially, they need to be looking at the environmentup instead of their action-down.

Mr. KUCINICH. Thank you, sir.

Mr. Burton.

Mr. BURTON. Thank you, Mr. Chairman.

I am only going to ask a couple of questions. It is late, and I

know you are tired of waiting on us running back and forth to the

floor to vote.

So the first question is, do you think that people who are having

mercury put into their bodies in any form should know about it?

All of you, I want to ask each of you. Do you think if a person

is getting an amalgam filling, they ought to know that it is 50 percent mercury?

How about you, Doctor? Shouldn’t we inform them what they are

getting?

Dr. MACKERT. Well, certainly, the ADA has supported and we

have a brochure that will be ready by the end of the year that talks

about all. We have currently brochures that talk about all the different filling materials, what they contain, their advantages and

disadvantages.

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I think that should be discussed by the patient and the dentist

together in making any decision about restorations.

Mr. BURTON. So you think it is the obligation of the dentist to

say to the patient before they put any kind of substance in their

mouth, what it is. If you are putting a silver filling in someone’s

mouth, just say, here is what we are putting in your teeth, copper,

zinc, mercury.

Dr. MACKERT. Well, I mean we could say the same things about

the white fillings that have bisphenol A and diglycidyl

dimethacrylate and all sorts of chemicals, that you could bewilder

a patient for sure with a list of materials that are in the white filling material, silanes.

Mr. BURTON. Mercury is known to be one of the most toxic substances on the earth. Don’t you believe?

Dr. MACKERT. It is really not.

Mr. BURTON. What is that?

Dr. MACKERT. It is really not. The OSHA maintains a list of 340

some odd toxins.

Mr. BURTON. Where is mercury? Where is mercury on that list?

Dr. MACKERT. It is not No. 1. It is not even a number.

Mr. BURTON. Well, where is it?

Dr. MACKERT. I have that information. I can provide that for you.

Mr. BURTON. Well, I would like to have it. But you will admit

it is toxic, mercury.

Dr. MACKERT. Yes, but so is vitamin A.

Mr. BURTON. No, no, no.

Dr. MACKERT. I mean we need to know that it doesn’t completely

define something to say that it is toxic. Vitamin A is a toxin. Chromium is a toxin.

Mr. BURTON. You know what really gets me, Doctor, is the Dental Association and the FDA and the HHS, all the agencies, don’t

want to just flat-out tell people they are putting mercury in their

mouths. You don’t want to do it.

Dr. MACKERT. We have done it.

Mr. BURTON. You can use every argument you want about other

vitamins, minerals and everything else that may be toxic, but mercury is 50 percent of what goes into a filling and you don’t want

to tell people that.

I don’t know how many I have talked to who have fillings in

their mouths, and they say I just have silver fillings. You say, do

you know what is in the silver filling, and they don’t know. Most

people don’t know. They don’t know it is 50 percent mercury.

Dr. MACKERT. Most people don’t know the ingredients in the dental, the white filling materials.

Mr. BURTON. You guys amaze me.

Anyhow, let me ask the rest of you gentlemen. Don’t you think

that people have a right to know when mercury is being put into

their mouths?

Mr. CLARK. Sir, I am a major believer in truth in advertising.

Mr. BURTON. OK, how about you, Mr. Bender?

Mr. BENDER. We actually commissioned a Zogby poll in 2006 on

this issue, and it was a statistically significant finding to the question of what is in an amalgam filling. Seventy-five percent of Americans didn’t know the main ingredient was mercury. When told

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that the main ingredient was mercury, 75 percent will be willing

to pay more to choose something else. Seven to one were in favor

of requiring dentists to tell patients that mercury was in amalgam.

There are a few other important statistics, and I will submit

them for the record in the next 5 days.

Personally speaking, I absolutely believe that it is a right to

know issue. We have informed consent from many other product

categories, and we know that mercury in the mouth is not helping

anyone’s health condition. Thank you.

Mr. BURTON. How about you, Mr. Smith.

Mr. SMITH. Yes.

Mr. BURTON. Thank you. That is very succinct and very to the

point.

The other thing I would just like to ask a question about is mercury in all forms getting into the environment is a real problem for

civilization. So I would just like to ask you, individually, don’t you

think mercury should be taken out of product that is possible so

it doesn’t get into the environment?

Mr. CLARK. I am afraid I couldn’t answer that as succinctly because I would like to know what kinds of things are tradeoffs. I

would want to know some of the risk assessments. I would want

to know some of the mitigations.

I think that there s a major role for mercury and certainly in my

background, from the national security background, I know that is

an element that is absolutely essential, but I also know that there

are plenty of safe ways to deal with it and keep it out of the environment.

Mr. BENDER. The State of Maine asked the Lowell Center for

Toxics Use Reduction to do an analysis of what the alternatives

were to mercury and products and processes in the United States,

and they did an extensive, actually two or three extensive reports

and found that for almost every single use, except for mercury in

fluorescent lights, there is a viable cost-effective alternative.

In the case of dental amalgam, I have been over to the Scandinavian countries and interviewed the dental authorities in those

countries. In the case of Norway and the case of Sweden, the use

of mercury amalgam is a non-issue because over 95 percent of the

placements today are not mercury fillings.

I would submit that those societies are not having problems

chewing or digesting their food or anything else, that societies are

surviving without mercury amalgam, and I would again challenge

the mainstream dental establishment to demonstrate why these alternatives that are being put in every day are not sufficient.

Finally, I would also submit that there is an association of mercury-free dentists, the IAOMT, whose members pledge not to use

any mercury and, including myself, I can attest that there is not

a need for mercury in fillings.

Mr. BURTON. Mr. Smith.

Mr. SMITH. Yes, I would just like to point out that quite a number of States, including my State and all of the New England

States, have adopted fairly comprehensive mercury products legislation that is phasing out many unnecessary uses of mercury, and

there are literally hundreds of those.

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The legislation that we also, that we have also requires that remaining uses of mercury to be labeled by the manufacturers so

that consumers know that there is mercury present in the product

and to provide appropriate information about how that material,

how those products at the end of their useful lives can be recycled.

Our legislation in Massachusetts also prohibits the disposal of

those mercury-containing items into regular trash and requires

manufacturers to support recycling programs in our State.

Mr. BURTON. Mr. Chairman, I would just like to request of the

panel.

Mr. Bender, if you have statistical data like you have, I would

like to have a copy of it because we are going to be talking about

this in the future, and the facts that you have stated and the polling data and all that stuff is very important. I would like to have

that.

Mr. Chairman, thank you very much.

Mr. KUCINICH. The Chair would appreciate your cooperating with

that request for Mr. Burton.

Mr. Smith, the New England States have been leaders in changing the behavior of dentists with regard to how they handle the

mercury they use and create in their work.

Can you tell us about the relative merits of the voluntary and

mandatory rule on the use of mercury separators and, in general,

do you believe you have been able to make significant reductions

in mercury emissions? What lessons do you have for the Nation?

Mr. SMITH. Sure. We started initially working with the Massachusetts Dental Association in a very collaborative way, and they

were really confident at the start of our efforts in 2001 that they

could encourage their membership to voluntarily adopt the use of

amalgam separators. We entered into a memorandum of understanding in 2001 with the MDS, basically focused on outreach to

dentists to encourage the installation of separators and the use of

best management practices.

Frankly, we did not track the installation very closely, but the

MDS reported that somewhere between 10 and 15 percent of dentists, after 2 years of that voluntary program, were using amalgam

separators, and that estimate was fairly consistent with reports

from manufacturers of amalgam separators. So we did have some

success in increasing their use, but it wasn’t as fast as we really

wanted to see.

In 2004, we, as I mentioned in my testimony, initiated a program

to develop mandatory regulations that would require the use of the

separators with a voluntary early compliance program. That has

been very successful, and we had 75 percent of the dentists sign

up in the first year of that program.

We now have the rule in place. It was adopted in the Spring of

2006, and essentially all of our dentists are using amalgam separators.

Mr. KUCINICH. As far as the Massachusetts Dental Society, was

the Society in favor of your mandatory requirement on dentists to

use mercury separators?

Mr. SMITH. I wouldn’t go so far as to say that they were in favor

of it, but they did participate actively in a stakeholder work group

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that we convened to develop our regulations, and they did not actively oppose it.

Mr. KUCINICH. So do you feel you can do the job of reducing mercury emissions to levels low enough to yield fish that are safe to

eat?

Mr. SMITH. Well, we are working in that direction, and we are

seeing some positive results. I didn’t speak to this today, but we

have some extensive fish monitoring that we have been doing in

Massachusetts and we have documented 20 to 30 percent reductions in mercury levels in our freshwater fish consistent with the

timeframe where we have been implementing our regional action

plan.

That is encouraging. Those fish are still not safe to eat, so we

have a long ways to go.

Mr. KUCINICH. Thank you, Mr. Smith.

Dr. Mackert, ADA has obviously recognized and reacted to the

environmental threat posed by mercury emissions coming from

dentists’ offices, but one of the conditions that ADA seems to have

placed on its participation in the effort is that State laws and regulations requiring that dentists use mercury separators be voluntary

rather than mandatory on dentists.

Will you explain why the ADA believes dentists should be given

the discretion to continue to pollute the environment with mercury?

Dr. MACKERT. Well, let me first address the end of your question

which is the contribution of dentists to the environment where I

have the EPA 2002 report here, and they are listed both by total

releases and by consumption. Dentists are No. 7 on this list. Gold

mining is No. 1. Utility coal combustion is No. 2. Switches and relays are No. 3.

We are less than 1 percent of the total amount of mercury entering the environment according to the EPA’s report. Gold mining accounts for over 90 percent of it by itself. So we can eliminate dental

mercury tomorrow, and essentially all of the mercury that is in the

environment today will be still be entering the environment if

amalgam were not.

Mr. KUCINICH. I look forward to having a hearing on gold mining, but I am looking at dental amalgams here. What I would like

to know is mandatory or voluntary, which is it? You are speaking

on behalf of the ADA.

Dr. MACKERT. That is correct.

Mr. KUCINICH. Can you agree that it would be better for the environment, since dentists are environmentalists, to participate in a

mandatory program?

Dr. MACKERT. I don’t agree that it would because we are currently able to take time to develop and promulgate mandatory

standards, and the ADA is already working now. Even though this

was passed by our House of Delegates only at the beginning of last

month, and yet we are already working on publishing this information, encouraging through the things that we have learned.

I mean there have been incidents in the past like have been mentioned here about efforts that have not been successful, but we

have learned from these and we will marshal all of the available

resources of the ADA to effect compliance.

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Mr. KUCINICH. So, Doctor, is it the position of the ADA that you

do not support mandatory separation? Do you support it or not?

Dr. MACKERT. We believe that we can accomplish it more rapidly,

more effectively by voluntary compliance.

Mr. KUCINICH. But why should dentists be able to choose whether or not to use the best available mercury-reduction technology?

Why should you be able to choose that?

Dr. MACKERT. Well, because it is going. I mean we have 100,000

dental offices in the United States. Are we going to have to develop

a government program to monitor 100,000 dental offices to see?

Why not see if we can accomplish this by voluntary means as has

been done, for example, in Minnesota?

Mr. KUCINICH. Let me ask you this, if I may, because we are running out of time here. What percentage of dental fillings are in fact

replacements of existing fillings?

Dr. MACKERT. I don’t have that information, but I can get that

for you.

Mr. KUCINICH. We understand it is about 70 percent according

to staff. Would you say that most of replaced fillings are probably

mercury amalgams? Is that from your experience?

Dr. MACKERT. Well, it probably would not be at this point because only 30 percent of the fillings placed are amalgam fillings.

Mr. KUCINICH. Where do the replaced fillings go?

Dr. MACKERT. They are collected. I mean they are removed from

the patient’s tooth and then collected in the traps or if the dentist

has amalgam separators.

Mr. KUCINICH. So how many tons of mercury in existing fillings

could be potentially replaced?

Dr. MACKERT. I got about 1,200 tons.

Mr. KUCINICH. Right, that is what the EPA says, 1,200 tons. So

that is a potential of over 1,000 tons of mercury that has to be safely sequestered.

Dr. MACKERT. The total amount is less than the gold mining that

is released in 1 year.

Mr. KUCINICH. I know. I mean you keep talking about gold mining, and I want to have a hearing on that.

Dr. MACKERT. Well, if we have a budget problem, for example,

in our personal finances.

Mr. KUCINICH. Doctor, really, please, let’s try to stay on the page

here. It is a potential of over 1,000 tons of mercury that has to be

safely sequestered before the mercury threat from dental amalgams really takes care of itself.

Mr. BURTON. Would the chairman yield?

Mr. KUCINICH. Of course, I will yield to my friend.

Mr. BURTON. Let me just cite some facts regarding the voluntary

effort of dentists to come up with these separators and put them

in their offices.

In the Seattle, King County Dental Society, they conducted a

study and they found after 6 years, after 6 years—it was a voluntary program—24 dental offices out of 900 decided to go along

with the separators. That is your voluntary program, 24 out of 900,

and that is why.

Dr. MACKERT. That was at the very beginning of the availability

of amalgam separators. There were mistakes made on both sides.

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We have learned from those mistakes, and then we look at Minnesota which was a different situation where 87 percent of dentists

complied voluntarily.

Mr. KUCINICH. I thank the gentleman for bringing that up.

Now I just want to ask Dr. Mackert again, how long would it

take? Just give me an estimate.

How long would it take for dentists to eventually replace dental

fillings with more than 1,000 tons of mercury? Would it be 10

years, 20 years, 30 years? How long would that take, do you think?

Dr. MACKERT. I don’t think there is any way to predict that.

Mr. KUCINICH. A very long time, I imagine.

Is it a long time? Do you think it would take a long time to replace it?

Dr. MACKERT. Are you saying that if we started literally trying

to do this tomorrow? How long would it take?

Mr. KUCINICH. Yes, how long would it take if you started tomorrow and you really made a concerted effort?

Dr. MACKERT. Or are you talking about fillings wearing out and

needing to be replaced?

Mr. KUCINICH. Just all those, you know the normal process and

pattern of people’s fillings breaking down and needing replacement,

dental accidents, things like that.

Dr. MACKERT. I don’t know how we could estimate that, but we

make an attempt.

Mr. KUCINICH. It would take a long time, though. See, what I am

trying to get at is it is going to be a long time before the problem

takes care of itself. So I just would like you to think about this

with the ADA because I remember seeing your testimony here that

you said it was a shrinking problem that would basically take care

of itself.

With the point that Mr. Burton made, what were those numbers

again, Mr. Burton?

Mr. BURTON. Twenty-four out of 900.

Mr. KUCINICH. If the problem takes care of itself, how is it going

to take care of itself if the dentists don’t help?

Dr. MACKERT. Well, as I said, that was at the very beginning of

the development of amalgam separators, and we didn’t know very

much about them at that point.

The situation is we have generated lots of information about

their use and installation. We have made efforts to make it easier

for dentists to know how to install separators.

Mr. KUCINICH. You do want to do something about this, don’t

you?

Dr. MACKERT. Yes, we do, and we will. We are.

Mr. BURTON. Mr. Chair.

Mr. KUCINICH. Sure, of course, Mr. Burton. It is your time.

Mr. BURTON. Let me just thank you for yielding.

That study went on from 1995 to 2000. It was 6 or 7 years ago.

Has it changed a great deal since then? Do you have any statistical

data on showing how many voluntarily decided to go along with the

separators?

Dr. MACKERT. I mentioned the case in Minnesota.

Mr. BURTON. I am talking about nationwide. We have 50 States.

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Dr. MACKERT. There are, as far as I know, about 15,000 separators in use currently. There are 10 States that have laws on the

books or have passed legislation which is not yet effective.

Mr. BURTON. Mr. Bender, do you have the statistics on that?

Mr. BENDER. I have an estimate from one amalgam manufacturer that approximately 56 percent of dentists in the United

States have amalgam separators today.

Mr. BURTON. Five, and that includes the States that have some

kind of mandatory requirement?

Mr. BENDER. That is correct.

Most of the Northeast States, although very admirable that I am

from the Northeast, but we are very small States. The States with

the big populations like California, Pennsylvania, the Great Lakes

States, none of those States have those requirements. So we are

talking about a relatively small part of the overall population that

has those mandates.

I might add that in each State where we have proposed legislation the ADA has fought us tooth and nail to oppose any kind of

mandatory programs, and they have consistently done that for the

last 5 years.

Mr. BURTON. Thank you.

Thank you, Mr. Chairman.

Mr. KUCINICH. To Dr. Mackert, on your testimony, on page 2, you

say that, well, I will start with page 1: ‘‘I don’t want to overlook

the obvious, so I will define what we are here to discuss. Dental

amalgam is an alloy made by combining silver, copper, tin and zinc

with mercury. It has been studied and reviewed extensively and,

based on the best available science, dentists continue to rely on it

as a safe and effective option for treating dental decay.’’

Would you concede that science is an ongoing process of an accumulation knowledge that causes people to evaluate and then reevaluate certain hypotheses that lend to certain conclusions and

that the progress of science inevitably means that things that

maybe you did yesterday, you don’t do today?

Dr. MACKERT. Well, science is knowledge, and we have knowledge of the studies that have been done. We have looked at this

issue. There have been two large studies published last year in

JAMA that looked at the effects of amalgam on children, and both

of these studies concluded.

Mr. KUCINICH. What about the environment?

Dr. MACKERT. Well, you know we have the numbers here from

the EPA 2002 report. There is dental mercury is a half of 1 percent

of the total mercury entering the environment. If we eliminate dental mercury, we will still have 99.5 percent of the mercury currently entering the environment after dental mercury is eliminated.

Mr. KUCINICH. Let me just say that I appreciate your being here,

and some of my closest friends are dentists based on the childhood

I had. So I appreciate the work that dentists do. It is important.

You know we are dealing with something here that basically is

a technology that you are stuck with. I mean this is it, and this

is what you use.

If all of a sudden this huge environmental movement starts moving up about mercury contamination here and there, I would imagVerDate 11-MAY-2000 11:32 Jun 05, 2009 Jkt 000000 PO 00000 Frm 00112 Fmt 6633 Sfmt 6633 U:\DOCS\49626.TXT KATIE PsN: KATIE
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ine that dentists do real well when they are not sitting in the chair,

and so you are in the chair today. I am not trying to pull teeth.

I am just trying to get some answers.

I want to go to Mr. Bender.

Now, you have testified because Dr. Mackert pointed out, look,

this is what the EPA says, not quite so bad, but you have testified

that the actual environmental emissions of mercury from source of

dental mercury is somewhere between seven and more than nine

tons per year. That is a lot higher than EPA’s estimate of about

1.5 tons per year.

Your number is an estimate. EPA’s number is an estimate. Why

should we believe your estimate is any more valid than the U.S.

EPA’s?

Mr. BENDER. Well, first of all, because the model that my consultant was using to project that estimate was based on an EPA

Region 5 scientist’s approach, and so we are not pulling these numbers out of thin air. We are actually following what the EPA scientist is using for an approach.

The other point I think that is important to point out here is that

there has been a lot of talk about mercury in the water, and that

was the focus in 2003. I think it seems like one of the criteria that

EPA uses is mercury releases to the air, and I think this testimony

today demonstrated very clearly that in the case of dental mercury

there is a significant doubt about the EPA numbers and there is

a range of numbers that are out there.

It also seems that EPA and the Congress are motivated by mercury air release issues, and so I would submit that it is time to

take another look at the air releases and not base it on 2002 or

2004.

Mr. KUCINICH. Let’s assume your estimate is closer to reality.

What then can we say about the significance of dentist use of mercury as a source of mercury pollution of the environment?

Mr. BENDER. Well, it is compared to the 50 tons that we are talking about from the coal-fired power plants, we are talking about a

10 ton number which is very significant.

Mr. KUCINICH. Is that significant in terms of the potential bioaccumulation?

Mr. BENDER. It absolutely is and in terms of the methylation of

mercury which gets into the fish that people eat.

Mr. KUCINICH. If actual emission are between 7 and 9 tons, you

have estimated that some 31 tons of mercury from dentists’ offices

are calculated to go into emissions and waste. Where does it all go

and where does the difference between the emissions and the total

go?

Mr. BENDER. As we detail in our extensive testimony, there are

several avenues. Clearly, the one that rises to the top is cremation,

and the new estimates are over three tons per year. If you were

to just do a simple mass balance and that is really what has been

lacking from all these equations, the mercury that goes in has to

go somewhere.

The question is, where does it go and how does it get there, and

a large question is how much goes into the air?

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Mr. KUCINICH. Well, we have a persistent toxin we are talking

about here. What safe way is there to dispose of mercury to prevent it from getting out into the environment?

Mr. BENDER. I am sorry.

Mr. KUCINICH. What is a safe way to dispose of mercury to prevent it from being released into the environment?

Mr. BENDER. Well, in the case of crematoria, it is a rather difficult situation because if you were to require these control devices

on crematoria, then you would be closing down all the small

crematoria in the country. So I would submit the long term answer

is to stop using dental mercury.

Mr. KUCINICH. You have said previously it is far preferable to

keep mercury from reaching the wastewater plant in terms of mercury reduction. Can you spell out for us from least cost per ton

emitted to most, what are the policy options for reducing mercury

emissions from dental use of mercury?

Mr. BENDER. Oh, absolutely, the first step is installation of amalgam separators in combination with best management practices.

We have seen example after example where when the dentists are

required to put in amalgam separators and once they comply with

that requirement, that we are seeing a 50 percent reduction, and

we are talking about $100 a month per dentist.

Mr. KUCINICH. I am going to just conclude with this comment,

and I want to go back to Dr. Mackert because I think what we need

to do is to look at this from the standpoint of having the ADA countenance this advancing science and the data that is available with

respect to effect in air.

I would imagine that when somebody trained to be a dentist

years ago, they weren’t thinking about mercury emissions from

crematoriums. It just doesn’t seem to me that would necessarily be

something in the books. I don’t know.

I am not a dentist, but it would seem to me that you are in an

area of effects that may not be something that had really years ago

been of great concern and significance, but now we know that there

are impacts.

So what I would just respectfully suggest to you—knowing that

America has the best dentistry, has people who are really committed to their patients, has dentists who really care about the health

of people because, after all, you are doctors—that you take into account this advancing science and, as Mr. Burton pointed out, to

look at the potential that participating in a mandatory program

might actually be to further strengthening public confidence in

dentists, which I am sure is already high but helping to secure it.

So thank you, sir.

Mr. Burton and then we are going to conclude the hearing.

Mr. BURTON. Yes. I just have one comment about this study that

took place in Seattle where only 24 out of 900 dentists voluntarily

put those separators in.

There were articles and paid advertisements in the Seattle, King

County Dental Journal. There were seven different editions that

were mailed to all members of the society. There was a guidebook

sent out. There were presentations and workshops at dental conventions within that area.

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There were cash rebates from companies that were selling the

amalgam separators. There were newspaper articles acknowledging

the ‘‘green’’ dentists. There was an outreach to dental supply companies. There was a curriculum prepared for the dental assistanthygienist training programs and technical assistance visits to dental offices.

And, only 24 out of 900 voluntarily complied. So I think they

were pretty well informed about it.

The other thing I would like to say about it is when the ADA certifies something for a company, a new product, a new kind of amalgam, do they get any kind of a fee for that? Does the ADA get any

kind of a fee if they certify from a company that their product gets

their stamp of approval?

Dr. MACKERT. I am sorry. The seal program now only applies to

over-the-counter products anyway. There is no seal program for

professional products.

Mr. BURTON. They don’t get any fee for anything except over-thecounter?

Dr. MACKERT. That is correct. They do not anymore.

There was a program that was run by far and away, primarily

at the expense of dentists through paying their dues. The ADA

charged a small fee for all materials, not just amalgam but any

product just to help defray some of the cost of laboratory analyses

that had to be done in certifying these products. But, as I pointed

out, that is not done anymore.

Mr. BURTON. It is not done anymore?

Dr. MACKERT. No.

Mr. BURTON. Did they ever have a patent on the amalgam?

Dr. MACKERT. The ADA has about 70, last time I checked, about

77 patents. I point out that the ADAD developed the white.

Mr. BURTON. Do any of them involve amalgams at all?

Dr. MACKERT. The two, over 30 years ago, did. They were never

licensed by the ADA. The ADA never made any money on these

patents.

In contrast, the ADA has, and I have the numbers. I can get

them for you, but they not only invented the white filling material

that is a primary alternative. That was developed by Ray Bowen

who is an ADA scientist.

Mr. BURTON. I would like, if you would just submit for the

record, any patents they have and any fees that they get for any

product that they give their stamp of approval on.

Dr. MACKERT. OK.

Mr. BURTON. I really want to thank all of you for waiting so long.

I know the chairman feels the same way I do.

I really would appreciate if you could submit for the record. I

would like to personally see all those statistics you have.

Mr. KUCINICH. I want to thank the gentleman from Indiana for

his contributions to this area of inquiry by the U.S. Congress. You

have been on this for years. You have really made a major contribution as a Member of Congress to further investigating this.

I am Dennis Kucinich, Chairman of the Domestic Policy Subcommittee of the Oversight and Government Reform Committee.

This has been a hearing on the Environmental Risks of and Regulatory Response to Mercury Dental Fillings.

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I want to thank each and every one of our witnesses for their patience and their participation in this. This committee will continue

its oversight of this matter, and I am sure our members of the staff

will be in touch with you. Thank you very much.

This committee stands adjourned.

[Whereupon, at 6:45 p.m., the subcommittee was adjourned.]

[The prepared statement of Hon. Elijah E. Cummings and additional information submitted for the hearing record follows:]

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