[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]





   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

                               __________

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              COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

                 HENRY A. WAXMAN, California, Chairman
TOM LANTOS, California               TOM DAVIS, Virginia
EDOLPHUS TOWNS, New York             DAN BURTON, Indiana
PAUL E. KANJORSKI, Pennsylvania      CHRISTOPHER SHAYS, Connecticut
CAROLYN B. MALONEY, New York         JOHN M. McHUGH, New York
ELIJAH E. CUMMINGS, Maryland         JOHN L. MICA, Florida
DENNIS J. KUCINICH, Ohio             MARK E. SOUDER, Indiana
DANNY K. DAVIS, Illinois             TODD RUSSELL PLATTS, Pennsylvania
JOHN F. TIERNEY, Massachusetts       CHRIS CANNON, Utah
WM. LACY CLAY, Missouri              JOHN J. DUNCAN, Jr., Tennessee
DIANE E. WATSON, California          MICHAEL R. TURNER, Ohio
STEPHEN F. LYNCH, Massachusetts      DARRELL E. ISSA, California
BRIAN HIGGINS, New York              KENNY MARCHANT, Texas
JOHN A. YARMUTH, Kentucky            LYNN A. WESTMORELAND, Georgia
BRUCE L. BRALEY, Iowa                PATRICK T. McHENRY, North Carolina
ELEANOR HOLMES NORTON, District of   VIRGINIA FOXX, North Carolina
    Columbia                         BRIAN P. BILBRAY, California
BETTY McCOLLUM, Minnesota            BILL SALI, Idaho
JIM COOPER, Tennessee                JIM JORDAN, Ohio
CHRIS VAN HOLLEN, Maryland
PAUL W. HODES, New Hampshire
CHRISTOPHER S. MURPHY, Connecticut
JOHN P. SARBANES, Maryland
PETER WELCH, Vermont

                     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               DARRELL E. ISSA, California
ELIJAH E. CUMMINGS, Maryland         DAN BURTON, Indiana
DIANE E. WATSON, California          CHRISTOPHER SHAYS, Connecticut
CHRISTOPHER S. MURPHY, Connecticut   JOHN L. MICA, Florida
DANNY K. DAVIS, Illinois             MARK E. SOUDER, Indiana
JOHN F. TIERNEY, Massachusetts       CHRIS CANNON, Utah
BRIAN HIGGINS, New York              BRIAN P. BILBRAY, California
BRUCE L. BRALEY, Iowa
                    Jaron R. Bourke, Staff Director















                            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, co-chair, 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

 
   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 
certain 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.
    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:]



[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    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.
    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 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 two-thirds, 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?
    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:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    
    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.
    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:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    
    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 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?
    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.
    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?
    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.
    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.
    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 estimated 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 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.
    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.
    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.''
    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 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.
    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.
    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?
    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.
    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 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.
    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.
    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 numerous 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.
    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:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    
    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 cost-effective 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 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 
thousands 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.
    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.
    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.
    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 
recommendations. 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.
    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 
environment-up 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.
    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 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.
    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 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.
    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. 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.
    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 
imagine 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?
    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.
    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 assistant-hygienist 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-the-counter?
    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.
    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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