Mercury amalgam as a restorative material

Health and Safety Executive did not have the information requested.

Dear Health and Safety Executive,

Please provide details about the physical and chemical/metal/alloy properties of Mercury amalgam used by the NHS in 1996 as a restorative material in dental surgical procedures.

Please include data about NHS use of biocides as sealer's when mercury amalgam was used in 1996:

1.The name of manufacturer(s)
2.The name of each substance in the product including the name of it's active substance and the amount of each substance as a percentage of the whole.
3.The classification of the biocidal/heavy metal/alloy product.
4.Particulars of any likely direct or indirect adverse side
effects.
5.Procedures to be followed and measures to be taken in the case of spillage or leakage of the biocidal product and the active substance contained in that biocidal product.
6. Safety data sheets for mercury amalgams and biocidal/paraformaldehyde based sealer's.

Is mercury amalgam as a restorative material used for pulp cavity fillings used currently?.

Yours faithfully,

Granito

Yours faithfully,

Granito

Health and Safety Executive

Dear Granito
 
Please see the attached response to your request.
 
Regards
 

Helen McGlown | Information Management Unit | Freedom of Information
Unit Health & Safety Executive | Knowledge Centre 1G Redgrave Court,
Merton Road, Bootle L20 7HS |

 

 

show quoted sections

 

 

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

Dear Health and Safety Executive,

Thank you for your response. However there does not appear to be an attachment with it as you stated.

Please advise.

Yours faithfully,

Granito

Health and Safety Executive

1 Attachment

Dear Granito

Apologies, please see attachment.

Regards

Helen McGlown | Information Management Unit | Freedom of Information Unit Health & Safety Executive | Knowledge Centre 1G Redgrave Court, Merton Road, Bootle L20 7HS |

(: +44(0) 151 951 4263 (VPN 523) | *: [email address]

show quoted sections

Dear Health and Safety Executive,

Thank you for your reply.

Who has the responsibility to issue biocide and heavy metal licences? Paraformaldehyde is produced from formaldehyde which is a pesticide and Mercury is a heavy metal, which is highly hazardous and extremely toxic. Some of these materials have industrial origins like Calcium Hydroxide. Are any of the chemicals listed here within your remit?

Thermoplastic polymers like Polyester, bioactive glass, bismuth oxychloride, barium sulphate.

Zinc oxide eugenol: Zinc oxide, eugenol, bismuth, barium

Polyketones: Zinc oxide, propionylacetophenone, vinyl copolymer

Epoxy: Bisphenol-A diglycidylether, bismuth oxide/zircon oxide.

Calcium hydroxide:Ca(OH)2, colophonium, different oxides, salicylate-based activator.

Silicone

Resin Based:Bis-GMA, UDMA, hydrophilic difunctional methacrylate, CaOH, Barium Sulphate, Barium Glass

Glass ionomer: Fluoroaluminosilicate glass, polyacrylic acid

Resin modified glass ionomer: Fluoroaluminosilicate glass, polyacrylic acid, water-soluble methacrylate monomer(HEMA)

Kind regards,

Granito

Health and Safety Executive

Dear Granito

I will pass this request for further information to the relevant team
for a response.

Regards

Helen McGlown | Information Management Unit | Freedom of Information
Unit Health & Safety Executive | Knowledge Centre 1G Redgrave Court,
Merton Road, Bootle L20 7HS |

show quoted sections

Dear Health and Safety Executive,

Thank you for your time and consideration of these matters.

Kind regards,

Granito

Health and Safety Executive

Dear Granito,

Thank you for your enquiry which has been passed on to the Chemicals
Regulation Directorate of the Health and Safety Executive, as the UK
Competent Authority for the registration of chemicals under EU REACH
legislation, and the UK regulator for pesticides, plant protection
products and biocides.

All chemicals manufactured within or imported into the EU (and therefore
the UK) in quantities of more than 100 tonne per year must be registered
under REACH (Registration, Evaluation, Authorisation and restriction of
Chemicals) legislation; this will be extended within the next few years
to cover chemicals manufactured or imported in quantities of 1 tonne or
more per year.

Registration is a requirement on the manufacturers or importers to
collect and collate specified sets of information on the properties of
those substances that they manufacture or supply. This information is
then used to perform an assessment of the hazards and risks that a
substance may pose in use and how those risks can be controlled. REACH
also imposes a requirement on those manufacturing or supplying
registered substances to provide information in the form of data sheets
to help those to whom they supply the substances to handle and use them
safely. Without registration, a substance may not be manufactured or
imported, so to this extent registration might be considered to be a
licence, though the term is not used within the REACH system, and it
does not automatically permit use of the substance in any situation or
for any purpose; there may, for example, be other legislation which
controls. Restricts or prohibits the use of a substance in specific
circumstances. In addition, substances used as or in human and
veterinary medicines, in foods and as foodstuff additives, and as or in
plant protection products and biocides are not evaluated in quite the
same way under REACH as other substances because they are subject to
their own specific regulatory regimes which impose alternative, usually
more extensive, evaluation processes.

As far as the substances listed in your enquiry are concerned, some
fairly extensive checking indicates that they are all used in or as
dental materials - indeed, the list appears to have been taken from
"Toxicity of endodontic filling materials" by Jon E. Dahl - see
http://www.rpcendo.com/45va9r1lkl7/Modul... (Table 1 on page
40). This means that, as indicated in the response to your earlier
enquiry, you should contact the Medicines and Healthcare Products
Regulatory Authority (MHRA) since they regulate dental materials and
'licence' them for use - please see
http://www.mhra.gov.uk/Howweregulate/Dev...
tiveImplantableMedicalDevicesDirective/index.htm (1st bullet point in
second list) - and they, and not the Health and Safety Executive should,
therefore, be in a position to provide you with information relating to
the substances in which you are interested.

Yours sincerely,

Ian Rowland

Ian Rowland
Access to Information Team
Regulatory Strategy and Communications Branch
Health & Safety Executive, Chemicals Regulation Directorate
Ground Floor, Mallard House, Kingspool, 3 Peasholme Green, York YO1 7PX
*: +44 1904 455954 (GTN 5138, VPN 528) | *: [email address]

show quoted sections

Dear MR Rowland,

Thank you for your reply.

Does that mean the Chemicals Regulation Directorate of the Health and Safety Executive, will get in touch with me with an answer?

You mentioned that 'they are all used in or as dental materials'

That may be the case and they are used in a number of other commercial industries and professions. Perhaps you already know many of the 'dental' products are produced from pesticides and industrial materials before they end up as medicines and 'medical disinfectants'? All of which, are potentially toxic and harmful to human and animal health. Most come with hazardous health & safety instructions. For example industrial cements and sealer's and alloys and heavy metals such as mercury.

I look forward to hearing from you further with regards Health and Safety Executive?

Kind regards

Granito

Health and Safety Executive

Dear Granito,

Thank you for your email. I apologise if it wasn't clear but I was responding to your email on behalf of the Chemicals Regulation Directorate of the Health and Safety Executive.

I also apologise if you feel that you are not getting the answers you expect to the questions you are posing. In my previous response, I inferred that you were asking the questions in your previous email within a dental use context, given that both it and your previous enquiry to the Health and Safety Executive seemed to relate to the use of dental materials, and so responded from that perspective. If that was incorrect, then if you could explain further in detail about the information you are asking for, we might be able to provide a more useful answer.

Similarly, I am not entirely clear what response you are expecting to the statements in your email below or what responsibilities you believe that the Health and Safety Executive has in respect of the substances mentioned, and therefore why the Health and Safety Executive is the appropriate body to which to address your email.

As I tried to explain in my previous response, the Health and Safety Executive, through its Chemicals Regulation Directorate, is the competent authority for the registration of chemicals under REACH legislation, but this does not mean that it has any powers to regulate the use of particular substances in particular circumstances such as, for example, medicines, including dental materials (which, as indicated, are regulated by the MHRA), or veterinary medicines (which are regulated by the Veterinary Medicines Directorate of Defra), or food additives (which are regulated by the Food Standards Agency), even if the same substance is involved. Similarly, the fact that some materials are or might be used in different 'areas' does not automatically mean that any one body has responsibility for regulating those materials in every area in which they are used. For example, an incident involving pesticides on a farm would be investigated by the Health and Safety Executive but an incident involving pesticides in someone's garden might well be investigated by the local authority.

To a great extent, this division of responsibilities is a reflection of the different risks that the substance might pose in different areas, and this, in turn may have a bearing on how that substance is regulated in those different areas and by whom. So mercury has more or less been phased out as a material used in thermometers and barometers because of the possible risk of exposure to the user should the instrument be damaged and the mercury escape whereas it is still used in dental fillings because of certain properties that mercury amalgam has - I should point out that the mercury forms an alloy with the other components of the amalgam and does not remain as pure mercury - and the risk to individual patients from the mercury is felt generally to be low, yet there are strict controls on the disposal of waste (including dental waste) containing mercury because of its possible effect on the environment (this aspect would be regulated by the Environment Agency).

I hope this makes at least some sense and helps explain why we might not have answered your questions to the extent you might have hoped for, but if you can explain more about what you are asking for we might be able to provide a more useful answer.

Yours sincerely,

Ian Rowland

Ian Rowland
Access to Information Team
Regulatory Strategy and Communications Branch 
Health & Safety Executive, Chemicals Regulation Directorate
Ground Floor, Mallard House, Kingspool, 3 Peasholme Green, York YO1 7PX
G: +44 1904 455954 (GTN 5138, VPN 528) | :: ian[email address]

show quoted sections

Dear MR Rowland

You wrote:

'Similarly, I am not entirely clear what response you are expecting to the statements in your email below or what responsibilities you believe that the Health and Safety Executive has in respect of the substances mentioned, and therefore why the Health and Safety Executive is the appropriate body to which to address your email.'

Please forgive my ignorance of such matters. Practise makes perfect. This is all new to me and quite the merry-go-round-and-round. There are such an array of departments one is so easily confused and overwhelmed by it all. Your time and help is much appreciated.

My recent correspondence was about the use of the chemicals mentioned previously in industrial environments. The MHRA deal with medical materials/substances that is clear. Do you deal with industrial substances and do they include any of the aforementioned chemicals/metals. How specific do I need to be?

Thank you for your time.

Kind regards

Granito

Health and Safety Executive

Dear Granito,

Thank you for your email. I'm wondering if it might help if you could explain something about the information you are looking for, what you hope it will tell you and what you are trying do with it. So far you have asked if HSE has some sort of responsibility for a number of substances, and have made a number of statements which imply that certain substances are dangerous but I am still unclear what the questions are that you are trying to answer or what actual information you are after, and I am still uncertain that HSE is actually the right organisation to answer those questions.

For example, no one in HSE will deal with any of the substances you list, in the sense of being involved directly in the manufacture or supply of them but part of HSE does deal with regulation of the manufacture, supply and use of chemicals, from a risk-management perspective to ensure that, as far as possible, this is done as safely as possible, so it is quite likely that HSE has inspection and/or enforcement responsibilities for companies manufacturing and/or supplying some of the substances in which you are interested, and another part of HSE is responsible for ensuring that companies which manufacture or import more than a certain quantity of a substance per year have registered that substance under REACH regulations. But does knowing this help you to find the answers to the questions you have? And does this mean that these substances fall within our remit in the sense in which you were asking the question or not?

Similarly, the fact that a substance is used in an industrial environment and then subsequently used in a medical environment, is not likely to tell you very much about the potential health risks to which you might be exposed in the medical environment. The risk posed by a substance to someone is usually dependent on the level and/or duration of the exposure, and part of risk management is determining what the 'safe' levels of use of a substance over time are in a given situation; in addition, practices and knowledge change and it can be misleading to compare, for example, how the risks posed by the use of a particular substance now are understood, compared to how those same risks were understood 10 or 15 years ago - knowing more about a substance now does not automatically mean that the substance is more dangerous now or that the risks were not managed properly then.

Would it also help to use a different email address, if you have or can obtain one? While I am quite happy to continue responding to the WhatDoTheyKnow? website, I am aware that correspondence with the website is in the public domain and appreciate that there may be things relating to your enquiry that you would not want to discuss in public.

Yours sincerely,

Ian Rowland

Ian Rowland
Access to Information Team
Regulatory Strategy and Communications Branch 
Health & Safety Executive, Chemicals Regulation Directorate
Ground Floor, Mallard House, Kingspool, 3 Peasholme Green, York YO1 7PX
G: +44 1904 455954 (GTN 5138, VPN 528) | :: ian[email address]

show quoted sections

Dear Ian Rowland Health and Safety Executive,

You mentioned data. How do you or anybody else know what health effects mercury amalgam (elemental mercury) is causing when no data is being collected or collated by the DOH or HSE or MRHR. Data that is necessary to determine whether a material is 'safe'. Agencies like WHO rely on it. There is a duty of care to consider that chronic chemical and metal poisoning is not being recorded at the national Poisons Centre. GP's are making the diagnosis's and therefore nobody is getting treatment. You are woefully and dangerously out of touch. Please cut the crap and do your research before you deliberately mislead me and the public.

“An understanding of the events that have shaped the last decade are predicated not such so much on acts to be learned but secrets to be discovered”

The objective of the Minamata Convention on Mercury is “to protect the human health and the environment from anthropogenic releases of mercury and mercury compounds” (Article 1).

The new treaty is an important step forward in the control of mercury pollution worldwide and represents a global consensus that mercury pollution is a serious threat to human health and the environment, and that action is needed to minimize and eliminate mercury emissions and releases in order to reduce that threat. The treaty also progresses the ambit of international chemical conventions in that it specifically provides for and highlights the need to protect human health, a provision that is often absent in other chemical treaties.

Significantly, this treaty includes a specific article related to human health (Article 16) with measures and activities that can be undertaken to assess and protect human health from mercury. It outlines an important requirement that information related to mercury and human health must not be kept confidential thereby underscoring the public Right To Know about mercury impacts on their health.

A new lawsuit claims that despite growing evidence of harm caused by dental amalgam, the US Food and Drug Administration (FDA) continues to delay the protection of public health against mercury tooth fillings.
The case has a number of plaintiffs, including the International Academy of Oral Medicine & Toxicology, which claim that the FDA has failed to respond within a reasonable time to petitions calling for either a formal ban of dental amalgam use, or placement in FDA's Class III, which requires: 1) additional restrictions for vulnerable individuals; 2) more stringent proof of safety; and 3) an Environmental Impact Statement.
According to attorney James M. Love, who filed the lawsuit on March 5, 2014, American consumers and dental professionals are being misled by the American Dental Association (ADA) the largest and most powerful advocate for continued amalgam use.

"The ADA has misrepresented FDA's lack of regulation as proof of safety, and continues to use this toxic dental filling, despite scientifically demonstrated risks," said Love. "Most individuals remain unaware that those 'silver' fillings, prevalently used as a dental restoration and covered by insurance policies, consist of 45-55% metallic mercury, and that there are health and environmental risks associated with those fillings."

Top scientists have repeatedly warned the FDA of the risk of harm caused by dental fillings, the lawsuit notes. For example, a February 2014 study, "[n]ew science challenges old notion that mercury dental amalgam is safe," published in the peer-reviewed journal, Biometals, uses the same studies cited by FDA in 2006, demonstrating that children are particularly at risk for mercury poisoning. The lawsuit suggests that the largest user of dental amalgam is the U.S. government, which uses amalgam for welfare recipients, prisoners, those residing on Indian Reservations, and the military, serving largely low-income people, including women and children, who are given no other options.

http://www.sott.net/article/275145-Lawsu...
http://link.springer.com/article/10.1007...

‘Progress in research has therefore made it clear that the RfD and the PTWI for methyl mercury are no longer valid definitions of “safe” exposure. They provide no margin at all below harmful doses, and do not protect public health. In fact, new research has often led to downward revision of environmental health criteria, and it seems evident that the time has come to update official definitions of tolerable methyl mercury exposure, to better align them with currently available epidemiological evidence.’

An Overview of Epidemiological Evidence on the Effects of Methyl mercury on Brain Development, and A Rationale for a Lower Definition of Tolerable Exposure Groth report 2012

WHO figures estimate that 6% of all global injuries were caused by poisoning. One third of these injuries occurred in Europe and involved
young adults and children suggesting accidental poisoning played a significant role. As such poisoning was preventable and poisons centres had an important role to play. While use of human observational data was a long-standing part of risk assessment practices, some sources of data remained under-utilized. Poisons centre data was one of many sources which had not been sufficiently explored in the past, others included injury data and data from biological monitoring. http://www.who.int/ipcs/publications/met...

In January 2013, governments from 140 countries agreed on final text for a global treaty on mercury, the first global treaty on the environment in well over a decade. The Treaty was then adopted in October 2013, and named the Minamata Convention. This Treaty reflects a global consensus that mercury poses a serious threat to human health and the environment, and applies pressure to eliminate mercury use from the global economy.

The related health clause under Article 17 which concludes, “For the purposes of this Convention, information on the health and safety of humans and the environment shall not be regarded as confidential” may provide leverage for those who wish to seek information from government on known sources and impacts of mercury on men, women and children in the UK. Information that has previously been classified may be released and publicised, raising awareness about mercury pollution in communities.

The hazards associated with mercury added products cannot be underestimated. The potential for mercury to be released at every stage from manufacture through useful life and disposal phase means that the potential for exposure during daily use of these products is high.

In 1833 the Crawcour brothers, two Frenchmen, brought amalgam to the United States, and in 1844 it was reported that fifty percent of all dental restorations placed in upstate New York consisted of amalgam. However, at that point the use of dental amalgam was declared to be malpractice, and the American Society of Dental Surgeons (ASDS), the only US dental association at the time, forced all of its members to sign a pledge to abstain from using the mercury fillings. This was the beginning of what is known as the first dental amalgam war. The dispute ended in 1856 with the disbanding of the old association. The American Dental Association (ADA) was founded in its place in 1859, which has since then strongly defended dental amalgam from allegations of being too risky from the health standpoint. The ratio of the mercury to the remaining metallic mixture in dental amalgam has not always been 50:50. It was as high as 66:33 in 1930. Relative ratios between the other metals used in dental amalgams has also been highly variable.

Conventional (or gamma 2)-amalgams have 32% silver and 14% tin, and they are most susceptible to corrosion due to their low copper content. Non-gamma-2 dental amalgams have been developed that were, however, found to release higher levels of mercury vapour compared with traditional amalgams. Amalgam is the dental material that has the strongest tendency to create galvanic currents and high electric potentials as it ages. The rate of mercury release with the corrosion is accelerated when the amalgam filling is in contact with old restorations or coupled with gold artefacts present in the mouth. (both of which apply to me)

In 2008, Sweden, Norway and Denmark deliberated a ban of mercury dental amalgam in favour of composite fillings. Since 1 April 2008, dentists in Denmark are forbidden to use mercury in fillings. The Swedish amalgam ban is for both environmental and health issues, according to the Swedish authorities.

What is most disturbing is that the UK government already have the data and know about the hazards of mercury added products and their cost to society in terms of human health impacts and environmental damage but we have yet to see the Minamata Treaty ratified and implemented. The UK government went against it’s own regulators in 2009, after they lobbied to stop it’s widespread use. Mercury and its compounds are highly toxic to humans, especially to the developing nervous system. They are also harmful to ecosystems and wildlife populations. Microbial metabolism of deposited mercury can create methyl mercury, which has the capacity to collect in organisms (bio-accumulate) and to concentrate up food chains (biomagnify), especially in the aquatic food chain. Methyl mercury is a well documented neuro-toxicant, which may in particular cause adverse effects on the developing brain. It readily passes both the placental barrier and the blood-brain barrier, therefore, exposures during pregnancy are of highest concern. It may also cause adverse effects on the cardiovascular system, thereby leading to increased mortality. Methyl mercury compounds are considered possible carcinogenic to humans according to the International Agency for Research on Cancer. Furthermore, inhalation of elemental mercury vapour includes symptoms such as tremors, insomnia, memory loss, neuromuscular changes, and headaches. Kidney and thyroid may be affected. http://www.zeromercury.org/

A product to be “phased-down” is dental amalgam. The mercury treaty clearly identifies the products that contain mercury. Many are scheduled for phase-down and phase-out and some are exempt. A progressive form of treatment known as Atraumatic Restorative Treatment (ART) has proven to be very effective for basic caries. ART is endorsed by the World Health Organization and used in 25 countries.

“A number of EU member states have also signed a new global treaty in 2013, the Minamata Convention on Mercury, added Attorney Edith Bon of Paris, European Union Counsel for the World Alliance for Mercury-Free Dentistry also. “It is now time for the Commission to act on this.”

The main alternative to amalgam in Europe is composites. This final opinion, also confirms that in contrast to amalgam, any adverse environmental impact of composites is "very limited."

Dr. Bent Christiansen, a dentist from Denmark’s Jutland, said “Amalgam alternatives are now used in the overwhelming majority of cases. From a dentist’s perspective, the alternatives are plainly superior to amalgam, which requires invasive removal of good tooth matter. By contrast, alternatives are minimally invasive. No earthly reason exists for using amalgam for any kind of cavity in a child or adult.”

Mercury is a highly neurotoxic product which can cause brain damage or even death to children and foetuses. Dental amalgam is about 50% mercury. Its use has increasingly been discredited, and it is virtually forbidden in Scandinavian nations.

the World Health Organization has collectively defined these conditions as “idiopathic environmental intolerances”(IEI), namely multiple chemical sensitivity (MCS), fibromyalgia (FM), chronic fatigue syndrome (CFS), dental amalgam disease, and others, among which the intolerances to microbial and environmental allergens or toxins, drugs, vaccines, specific foods, synthetic implants, and possibly new biomaterials are also included. In view of the progressively increasing knowledge and awareness regarding these diseases, they are presently better described collectively as “sensitivity-related illnesses” (SRI).

SRI symptoms appear mainly in adult life, with higher prevalence in women, although a growing number of paediatric cases has been recently registered, and evidences are accumulating for a role of in-uteri sensitization . For the prototypical MCS, the disease onset is commonly self-reported as a single precipitating event following a severe intoxication, or as a chronic exposure to lower doses of an environmental pollutant , either in the occupational or in the domestic setting.

Then, the intolerance becomes chronic, with symptoms elicited by the same incident, but also by different, multiple incidents, resolving at their removal. Challenges for establishing differential diagnostic criteria for various SRI lie in: (i) the absence of consensus on case definition in all SRI conditions, with the exception of FM; (ii) the wide variety of multi-organ symptoms, including psychosomatic, neurological, memory loss, mood disorders, post-traumatic distress, chronic fatigue, muscular, chronic bronchitis and asthma, eye-nose-throat, gastro- intestinal, cardiac, autoimmune disorders.

Governments have recognized that mercury poses a global threat to human health and the environment. IAOMT petitioned the World Health Organisation to consider banning mercury. In 2006, the FDA consulted a Joint Panel of physicians and dentists to review the FDA’s own White Paper on dental amalgam. The Panel ruled 13 to 7 that the White Paper did not demonstrate adequate proof of safety. In 2009, in their position statement, the Scientific Advisory Board of the International Academy of Oral Medicine & Toxicology (IAOMT) stated, “[i]t is incompatible with current, valid scientific evidence to continue to endorse or otherwise condone the use of a permanently implanted material in teeth that continuously emits a very potent enzyme inhibitor and metabolic toxin.”

In 2010, at the urging of its own scientific advisory panel, the FDA agreed to review its amalgam rule based on current science.

The agency announced its intention to complete its review by 2011, but still has not acted. A February 2014 study, “[n]ew science challenges old notion that mercury dental amalgam is safe,” published in the peer-reviewed journal, Biometals, uses the same studies cited by FDA in 2006, demonstrating that children are particularly at risk for mercury poisoning. A 2013 study, “Woods et. al. 2013 – Neurobehavioral Data From CATs Reveals Greater Hg Effects In Boys With Metallothionein Gene Variant,” demonstrates that certain genetic factors make young boys more susceptible to adverse neurobehavioral effects from mercury.

Mercury is a persistent toxic chemical that can build up in the body. It is particularly toxic to the kidneys and the nervous system. Young children are more sensitive to mercury and are exposed to mercury through breast milk. The foetus is exposed to mercury from placental transfer of mercury from a pregnant woman’s teeth containing amalgam. “We have banned mercury in disinfectants, thermometers, and many other consumer products,” said Griffin Cole, DDS, President of the IAOMT.

“There is no magic formula that makes mercury safe when it’s put into our mouths. It’s inexcusable to use mercury in dental fillings when there are much safer alternatives.” A previous 2007 lawsuit, Moms Against Mercury v. Eschenbach, alleged that more than thirty years ago the FDA was legally obligated to classify dental amalgam, but did not do so. In direct response to this lawsuit, the FDA agreed to classify dental amalgam. However, FDA classified the device in Class II, assigning no controls or other measures intended to protect the public. http://iaomt.org/lawsuit-filed-today-fda...

Plaintiffs in the current lawsuit include: International Academy of Oral Medicine & Toxicology, Moms Against Mercury, DAMS, Inc., CoMeD, Inc., and several individuals who were adversely affected by the mercury from amalgam fillings. Plaintiffs submitted their first petitions in July 2009, which initially precipitated much promising activity, but have since been ignored by FDA.

This lawsuit culminates the allegations set forth in the previous five petitions submitted to FDA. In 1991 and 2003, the World Health Organization (WHO) confirmed that dental amalgam is the greatest source of human exposure to mercury in the general population, and in 2005, a WHO report listed adverse health effects caused by mercury exposure, cautioning, “Recent studies suggest that mercury may have no threshold below which some adverse effects do not occur.”

On its dental amalgam webpage in 2008, the United States Food and Drug Administration (FDA) warned about dental mercury’s potential neurotoxic effects on children and foetuses, but later removed the warning without explanation. Later, at a 2010 FDA Dental Products Panel meeting to discuss the health impacts of mercury amalgam fillings, Dr. Suresh Kotagal, a paediatric neurologist at the Mayo Clinic, concluded, “…I think that there is really no place for mercury in children.” The global burden of diseases attributed to exposure to hazardous chemicals is already significant and is likely to become more serious. Infants, children and pregnant women are the most vulnerable to the health effects of mercury. The same FDA Panel encouraged consideration for limiting dental mercury for pregnant women and children, as well as labelling to warn consumers of the mercury risks. The public was told that FDA’s ruling on the issue would be made by December 31, 2011. However, no action has been taken to date.

Amalgam risk assessments conducted in 1995, 2010, and 2012 by Dr. G. Mark Richardson, an expert to the European Union’s Scientific Committee on Health and Environmental Risks (SCHER), revealed that toxic levels of mercury were released from dental fillings. Other risk assessments confirm these findings. Additional “credible” scientific research released in 2012 includes a Yale University study substantiating occupational dental mercury exposure, two studies corroborating the harmful impacts of mercury fillings on children and adolescents, and a study demonstrating that maternal amalgam fillings release mercury into breast milk.

Opponents to the ADA’s position on mercury fillings cite a 1995 legal brief filed by ADA attorneys asserting, “The ADA owes no legal duty of care to protect the public from allegedly dangerous products used by dentists. The ADA did not manufacture, design, supply or install the mercury-containing amalgams.” Similarly, last year, the ADA lobbied the U.S. Department of State to oppose a ban or limit on the use of amalgam fillings in connection with the United Nations Environment Programme’s legally-binding mercury treaty. However, the treaty text agreed upon in January includes the global phase-down of dental mercury fillings. Dr. William Virtue, DDS, President of the IAOMT, is concerned.

“While worldwide action is being taken to protect humans and the environment from mercury, the ADA continues to mislead the public into believing that one of the most toxic elements on this planet somehow becomes less poisonous when it is placed in their mouths.”

Yours faithfully,

Granito

Health and Safety Executive

Dear Granito,

Thank you for your email and the information you have provided. However, none of the issues you raise fall within HSE's responsibilities so there is little I can comment on other than suggesting whom you should contact if you wish to discuss these issues further

Concerns relating to the use of mercury amalgams and other dental materials: as stated in previous emails, dental materials are regulated by the Medicines and Healthcare Products Regulatory Authority (MHRA) and if you have concerns about the use of mercury amalgam or any other material as a dental material, you should contact MHRA to discuss this matter further. The MHRA is unlikely to be able to comment on decisions made by other countries in respect of particular dental materials.

Concerns relating to information on chronic chemical and metal poisoning not being recorded by the National Poisons Centre: the National Poisons Information Service (NPIS) provides a service under contract to Public Health England (PHE) and it is PHE that sets the terms of the contract - please see http://www.npis.org/uniformservice.html. If you have concerns that NPIS is not recording information on particular types of poisoning incidents, you should contact PHE - please see https://www.gov.uk/government/organisati... - to discuss this matter further.

Concerns relating to the treatment by GPs of chronic chemical and metal poisoning: guidance to GPs and others on health-related treatments is provided by the National Institute for Health and Care Excellence (NICE) – see http://www.nice.org.uk/aboutnice/whatwed... and http://www.nice.org.uk/aboutnice/whatwed.... If you have concerns that chronic chemical and metal poisoning cases are not being treated by GPs, you may wish to contact NICE to discuss any existing guidance..

Concerns about the implementation of the Minamata Convention on Mercury: the Department for Environment, Food and Rural Affairs (Defra) is the UK Government Department responsible for UK policy in relation to the Minamata Convention. You should therefore contact Defra - please see http://www.defra.gov.uk/ - for information on how the UK is responding to the Convention.

Yours sincerely,

Ian Rowland

Ian Rowland
Access to Information Team
Regulatory Strategy and Communications Branch
Health & Safety Executive, Chemicals Regulation Directorate
Ground Floor, Mallard House, Kingspool, 3 Peasholme Green, York YO1 7PX
*: +44 1904 455954 (GTN 5138, VPN 528) | *: [email address]

show quoted sections

Looking for an EU Authority?

You can request documents directly from EU Institutions at our sister site AskTheEU.org . Find out more .

AskTheEU.org