ADA: Beryllium in Dentalmaterialien verboten!
10.1.2003
Zitat aus http://www.dimensional.com/~mhj/1999.html:
------------------------------------------------------------------------------- Beryllium Support Group 1999 Beryllium Related Journal Articles Balkissoon, R. C. and L. S. Newman (1999). Beryllium copper alloy (2%) causes chronic beryllium disease. J Occup Environ Med 41(4): 304-8. We describe two newly confirmed cases of chronic beryllium disease who presented to our clinic from a facility that only used 2% beryllium copper alloy. These cases illustrate that the 2% beryllium copper alloy continues to cause chronic beryllium disease and that appropriate preventive measures must be taken to control exposures and educate industries and their workers about the hazards of beryllium alloys. -------------------------------------------------------------------------------
Bei der Bearbeitung von Beryllium und Beryllium-haltigen Legierungen durch Sägen, Fräsen, Bohren und Feilen entstehen feine Späne, die in der Lunge die unheilbare Beryllium-Krankheit, eine Krebs-Art, verursachen können.
Beryllium ist enthalten in Beryllium-Kupfer, aus dem Kühlkörper und Kontaktfedern für Elektronik hergestellt werden.
Wieviel Beryllium ist in Dental-Legierungen ?
Mit Datum vom 10.1.2003 teilt die ADA mit :
------------------------------------------------------------------------------- [/QUOTE] ADA News Posted Jan. 10, 2003 Court denies injunction of ADA Seal program By James Berry A federal judge Dec. 31 rejected a dental manufacturer's plea for an injunction that would have prevented the ADA from going public with a decision to lift its Seal of Acceptance from all products containing the base metal beryllium. In denying the preliminary injunction sought by CMP Industries LLC, Judge John A. Nordberg of the Northern Illinois U.S. District Court said the Association's Council on Scientific Affairs relied on a "significant amount of new evidence" in deciding to withdraw the ADA Seal from products containing beryllium alloy. New York-based CMP sued the ADA in October 2002, alleging that the council had unlawfully revised its requirements for acceptance of base metal alloys to exclude beryllium as a component of an ADA-accepted product. The company also sought an injunction to bar the Association from making its decision public knowledge (see related story, Change of requirements for ADA Acceptance of base metal alloys). Judge Nordberg noted in a six-page opinion that, in making its decision, the council reviewed a warning on beryllium from the U.S. Occupational Safety and Health Administration, as well as other information on beryllium safety. In April 2002, OSHA issued a Hazard Information Bulletin warning that beryllium exposure posed a serious potential health threat in dental workplaces. The agency also recommended, for the first time, that alternatives to beryllium be used. CMP is one of nine companies with a total of 14 beryllium-containing products granted the ADA Seal since the mid-1960s. Used in fabricating some partial dentures and crowns, beryllium has been linked to respiratory ailments in humans. ADA Chief Counsel Peter M. Sfikas hailed Judge Nordberg's decision as a victory for both the Association and the public at large. "The court's decision recognizes the importance of the ADA as a respected and impartial body, and reaffirms the right of the ADA to express its opinion on matters affecting public safety," Mr. Sfikas said. CMP argued that the ADA's proposed statement on beryllium constituted "trade disparagement" because it implied that CMP's products are unsafe. Judge Nordberg said he found it "hard to see how the implied statement is untrue." He added, "The ADA correctly states that the only implied statement that can be taken from the proposed announcement is that the ADA believes that beryllium products pose enough of a safety concern to justify removing the Seal. This statement cannot be untrue; the ADA's opinion is what it is." CMP also argued that the ADA must have a "significant amount of new evidence" that a product is no longer safe or effective before revoking the Seal or declining to renew it. "The argument," said Judge Nordberg, "boils down to whether the OSHA bulletin could be considered significant new evidence. The ADA council thought it was, and this court agrees." If CMP were to prevail in this case, he said, "the harm to the ADA would be significant. It would be unable to express a truthful opinion on an important public safety issue, its reputation as an impartial body could be questioned, and it would be subject to lawsuits from those harmed from products bearing the ADA Seal." The Council on Scientific Affairs "acted in a conscientious manner," Judge Nordberg said. "Its decision was not specifically targeted at CMP but applied to all applicable companies." He added, "The reason that the Seal is so respected—and, in fact, the reason why CMP is fighting so hard to keep it—is that it represents the independent and respected opinion of the ADA." CMP's lawsuit contending the ADA wrongfully terminated the Seal is still pending before the court. The ADA has filed a motion to dismiss the lawsuit. [/QUOTE] -------------------------------------------------------------------------------
------------------------------------------------------------------------------- [QUOTE] ADA News Posted Jan. 10, 2003 Change of requirements for ADA Acceptance of base metal alloys The Council on Scientific Affairs recently changed the requirements for ADA Acceptance of base metal alloys. Products containing beryllium will no longer be considered for Acceptance. This action was taken in response to an April 2002 OSHA Hazard Information Bulletin (HIB) titled, Preventing Adverse Health Effects for Exposure to Beryllium in Dental Laboratories. The OSHA HIB makes the following points: * Cases of chronic beryllium disease (CBD) are continuing to occur among dental laboratory technicians working with dental alloys containing beryllium. Recent studies have questioned whether the Permissible Exposure Limit (PEL) is adequate to prevent CBD among exposed workers. The current PEL limits occupational exposure to 2.0 μg/cubic meter over an 8-hour time weighted average. * Extensive engineering, work practice and other controls are recommended to protect workers exposed to beryllium in dental laboratories and dental offices where appliances containing beryllium are fabricated or modified. However, the very first OSHA recommendation is, "Where possible, alloys that do not contain beryllium should be substituted for beryllium-containing alloys in dental work." There are many substances used in dentistry that require proper handling by dental care workers to avoid occupational risk. However, this is the first time that OSHA has gone on record recommending substitution of one dental product for another as the first level of control. The Council concluded that suitable base metal alloys without beryllium are available to replace beryllium-containing alloys in all dental applications. Consequently, beryllium-containing base metal alloys will no longer be considered for ADA Acceptance. The Council saw no evidence to suggest that dental devices made from items made from beryllium-containing alloys (e.g., crowns, bridges, partial dentures) cause any ill effects in patients. For more information, see the statement on the proper use of beryllium-containing alloys. --> LINK: http://ada.org/prof/prac/issues/statements/alloys.html [/QUOTE] -------------------------------------------------------------------------------
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Proper Use of Beryllium-Containing Alloys
Many dental prosthetic restorations placed in the United States are
made of a variety of base metal alloys. Base metal alloys are composed
of metallic elements other than gold, silver, platinum, palladium,
ruthenium, iridium, rhodium, and osmium.
Beryllium is added to some base metal alloys for use in crowns, bridges
and partial denture frameworks. Incorporation of beryllium into the
base metal alloy formulation facilitates castability (lowering the melting
temperature and surface tension) and increases the porcelain metal
bond strength.1,2 Beryllium also allows the alloys to be electrolytically
etchable for bonding veneers in conjunction with resin-bonded
restorations.3
However, exposure to beryllium vapor or particles is associated with a
number of diseases from contact dermatitis4,5 to chronic
granulomatous lung disease, known as chronic beryllium disease
(CBD). In addition, beryllium and some beryllium compounds in vapor
and particulate form have been shown to be carcinogenic based on
human epidemiological and animal experimental models.6 Tumors
linked to beryllium include lung carcinoma6 and osteosarcoma.7
Potential hazards or risks from exposure to beryllium result from
melting, grinding, polishing and finishing procedures. The risk is
greatest during the casting process in the absence of an adequate
exhaust and filtration system. Both the National Institute of
Occupational Safety and Health (NIOSH) and the ADA8 have
promulgated standard practices for the safe management of
beryllium-containing alloys. These practices have focused on dental
laboratories where beryllium-containing alloys are routinely used for the
fabrication of crowns, bridges and partial dentures.
According to the Occupational Safety and Health Administration
(OSHA) the current Permissible Exposure Limits (PELs) for beryllium
allow exposure to 2 micrograms per cubic meter of air (2 mg/m3) as an
8-hour time-weighted average (TWA), between 5 mg/m3 and 25
mg/m3 exposure for up to 30 minutes at a time, and 25 mg/m3 as a
maximum peak limit that can never be exceeded. However, some
recent studies and reports have questioned whether the current 2
mg/m3 PEL for beryllium in the workplace is adequate to prevent the
occurrence of CBD among exposed workers.9,10 A recommendation
of 0.1 mg/m3 for the 8-hour TWA has been made based on a study of
unaffected populations near a beryllium plant.11
In a recent Hazard Information Bulletin entitled Preventing Adverse
Health Effects from Exposure to Beryllium in Dental Laboratories
("OSHA Bulletin"), 12 OSHA expressed concern that cases of CBD are
continuing to occur among dental laboratory technicians and cautioned
the nation's dental laboratories and lab technicians to be alert to the risk
of developing CBD from exposure to dust from beryllium.
With regard to the dental office, reports of toxicity to
beryllium-containing alloys are limited to a few cases of transient
contact dermatitis.4,5 The recent OSHA Bulletin does not appear to
question the fundamental safety and effectiveness of
beryllium-containing alloys when handled appropriately, and no cases
of CBD have been documented to date in dental practitioners, dental
office employees, or patients. The OSHA Bulletin does, however,
indicate that the precautions regarding the use of beryllium-containing
alloys apply to dental offices if these are fabricated or modified there.
So in cases where beryllium-containing dental prostheses are ground or
polished in the dental office, precautions should be considered to
minimize any exposure to beryllium-containing dust.
The following OSHA recommendations should be taken by dental
practitioners using beryllium-containing alloys for dental prostheses:
* Obtain Material Safety Data Sheets (MSDSs) for all dental alloys
used in the dental office;
Where possible, alloys that do not contain beryllium should be
substituted for beryllium-containing alloys in dental prostheses (a
number of other non-beryllium-containing alloys have been
granted the ADA Seal of Acceptance);
* All procedures related to grinding or polishing
beryllium-containing dental alloys should be conducted using
properly designed and installed local exhaust ventilation;
Vacuum systems and local exhaust ventilation systems should be
equipped with high-efficiency particulate air (HEPA) filters;
* When possible, use local exhaust ventilation (hoods) properly to
minimize the generation of dust when working with
beryllium-containing alloys;
* Use HEPA vacuums to clean equipment and the floor around the
work area;
* Monitor employee exposures to airborne beryllium dust, using
personal sampling techniques on a regular basis, to ensure that
beryllium exposures are below the OSHA PELs and are as low
as feasible;
* Limit the number of office staff who have access to areas where
beryllium-containing alloys are being ground or polished;
* To minimize skin contact and to reduce take-home exposures
and beryllium contamination of non-work areas, ensure that
protective clothing is worn in areas where dental prostheses
containing beryllium alloy are being ground or polished;
* Recent studies suggest that exposure to beryllium at levels below
OSHA's 2 mg/m3 PEL may have caused CBD in some
individuals. Therefore, even in the dental office where exposures
are likely to be considerably below the 2 mg/m3 limit, dentists
should consider providing their beryllium-exposed staff with
National Institute of Occupational Safety and Health
(NIOSH)-approved air-purifying respirators equipped with
100-series filters (either N-, P-, or R-type as applicable) or,
where appropriate, powered air-purifying respirators equipped
with HEPA filters. Clinicians should also note that short-term
exposures may exceed the 2 mg/m3 PEL.11
* Use of a surgical type mask does not provide adequate
respiratory protection because it does not seal the face or
effectively filter out fine particles.
Dentists and their staffs may obtain additional information about
beryllium-containing products directly from manufacturers or at the
OSHA Web site ( www.osha.gov ). This informational statement is
advisory in nature and intended to assist dentists in providing a safe and
healthful workplace.
References
1. Leinfelder K. An evaluation of casting alloys used for restorative
procedures. JADA 1997;128:37-45.
2. Covington J et al. Beryllium localization in base metal dental casting
alloys. J Biomed Mat Res 1985;19:747-750.
3. Perez A. Given the recent controversy concerning beryllium, what
should be our concern or not be our concern as dental lab managers. J
Dent Tech 2000;17(5):28-29.
4. Haberman A et al. Contact dermatitis from beryllium in dental alloys.
Contact Dermatitis 1993;28(3):157-62.
5. Vilaplana J et al. Occupational and non-occupational allergic contact
dermatitis from beryllium. Contact Dermatitis 1992;26(5):195-8.
6. Kuschner M. The carcinogenicity of beryllium. Environ Health
Perspect 1981;40:101-5.
7. Fodor I. Histogenesis of beryllium-induced bone tumors. Acta
Morphol Acad Hung 1997;25(2-3):99-105.
8. Moffa, J. P. and Jenkins, W. A. Status report on base-metal crown
and bridge alloys. JADA 1974; 89: 652-55
9. Balkissoon, R. C. and Newman, L. S. Beryllium Copper Alloy (2%)
causes chronic beryllium disease. J. Occup Environ Med 1999; 41:
304-8.
10. Martyny J. W. Hoover, M. D. Mroz, M. M. Ellis, K. Maier, L. A.
Sheff, K. L. Newman, L. S. Aerosols generated during beryllium
machining. J. Occup. Environ. Med. 2000; 42: 8-18.
11. Wambach P.F. and Tuggle R.M. Development of an eight-hour
occupational exposure limit for beryllium. Appl. Occup. Environ Hyg.
2000, 15. 581-87.
12. Occupational Safety and Health Administration. OSHA Hazard
Information Bulletin: Preventing Adverse Health Effects from Exposure
to Beryllium on the Job. Available at:
http://www.osha-slc.gov/dts/hib/hib_data/hib19990902.html
Accessed April 12, 2002.
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U.S. Department of Labor
Occupational Safety & Health
Administration
www.osha.gov
OSHA Hazard Information Bulletins
Preventing Adverse Health Effects From Exposure to Beryllium on the Job.
OSHA
Hazard Information Bulletins - Table of Contents by Year
Information Date: 1999 09 02
Record Type: Hazard Information Bulletin
Subject: Preventing Adverse Health Effects From Exposure to
Beryllium on the Job.
September 2, 1999
WARNING!
INHALING BERYLLIUM DUST OR FUMES MAY CAUSE SERIOUS,
CHRONIC LUNG DISEASE AMONG EXPOSED WORKERS;
THIS LUNG DISEASE CAN BE FATAL.
BERYLLIUM CAN ALSO CAUSE LUNG CANCER.
The Occupational Safety and Health Administration (OSHA) has recently
obtained information suggesting that OSHA's current 2 micrograms per cubic
meter of air (micrograms/m3) eight-hour time-weighted average (TWA)
permissible exposure limit (PEL) for beryllium in the workplace may not be
adequate to prevent the occurrence of chronic beryllium disease (CBD), a
disabling and often fatal lung disease, among exposed workers.
OSHA is publishing this Hazard Information Bulletin to alert employees
working with beryllium about the hazards associated with their work. It
describes engineering controls, work practices, and personal protective
equipment recommended for controlling exposures to beryllium through
inhalation and skin contact. It also suggests health surveillance methods to
identify workers who may have become sensitized to beryllium, or who may
have CBD.
BACKGROUND
Beryllium is a metal that is found in nature, especially in beryl and
bertrandite rock. It is extremely lightweight and hard, is a good conductor
of electricity and heat, and is non-magnetic. These properties make beryllium
suitable for many industrial uses, including: metal working (pure beryllium,
copper and aluminum alloys, jet brake pads, aerospace components); ceramic
manufacturing (semi-conductor chips, ignition modules, crucibles, jet engine
blades, rocket covers); electronic applications (transistors, heat sinks,
x-ray windows); atomic energy applications (heat shields, nuclear reactors,
nuclear weapons); laboratory work (research and development, metallurgy,
chemistry); extraction (ore and scrap metal); and dental alloys (crowns,
bridges, dental plates); and sporting goods (golf clubs, bicycle frames).
CURRENT EXPOSURE LIMITS
The current OSHA PELs for beryllium are 2 micrograms/m3 as an 8-hour
TWA, 5 micrograms/m3as a ceiling not to be exceeded for more than 30
minutes at a time, and 25 micrograms/m3as a peak exposure never to be
exceeded. The OSHA limits have been in place for nearly 30 years and have
not been revised in that time. The American Conference of Governmental
Industrial Hygienists (ACGIH) has recently published a Notice of Intended
Change for its Threshold Limit Value (TLV) for beryllium that would lower
the TLV from the current level of 2 micrograms/m3 to 0.2
micrograms/m3averaged over an 8-hour work shift.
POTENTIAL ADVERSE HEALTH EFFECTS FROM BERYLLIUM EXPOSURE
CHRONIC BERYLLIUM DISEASE
Chronic beryllium disease (CBD) primarily affects the lungs. CBD may occur
among people who are exposed to the dust or fumes from beryllium metal,
metal oxides, alloys, ceramics or salts. It occurs when people inhale
beryllium in these forms. CBD usually has a very slow onset, and even very
small amounts of exposure to beryllium can cause the disease in some people.
In some cases, CBD develops while workers are still on the job, but in others
it may not develop until many years after a person has stopped working in the
beryllium industry, or has been transferred to a job that does not involve
beryllium exposure. The amount or length of exposure to beryllium necessary
to cause a specific individual to develop CBD is not known, but recent
information suggests that exposure below OSHA's 2 micrograms/m3 TWA
PEL over a very short time (weeks or months) can lead to CBD in some
workers.
Signs and Symptoms of Chronic Beryllium Disease
Workers with advanced CBD may have one or more of the following
symptoms: unexplained cough; shortness of breath, especially with activity;
fatigue; weight loss or loss of appetite; fever; or night sweats. However,
because the disease may develop slowly over a period of many years,
workers may have the disease for a long time without knowing it.
BERYLLIUM SENSITIZATION
CBD only develops in workers who have become sensitized to beryllium. A
sensitized worker is one who has developed an allergic reaction to beryllium.
A worker may become sensitized at any point during job exposure, or in some
cases may not become sensitized until after leaving a job where there has been
beryllium exposure. Beryllium sensitization can be detected through the use of
a blood test called the BeLPT, which stands for beryllium lymphocyte
proliferation test. This test measures how specific white blood cells called
lymphocytes react to beryllium. A positive test result means that a worker is
sensitized.
ACUTE BERYLLIUM DISEASE
Acute beryllium disease usually has a quick onset and has symptoms that
resemble those of pneumonia or bronchitis. The acute form of the disease is
believed to occur as a result of exposures well above the current PEL. This
form of beryllium disease is now rare.
CANCER
Studies of workers exposed to beryllium have demonstrated significantly
elevated risks of lung cancer. The International Agency for Research on
Cancer (IARC), the expert cancer agency of the World Health Organization,
has concluded that exposure to beryllium can cause lung cancer in humans.
SKIN DISEASE
A skin disease, which is characterized by poor wound healing and a rash or
wart-like bumps, can occur as a result of the skin being exposed to beryllium
dust.
RECOMMENDATIONS
OSHA recommends the following measures to reduce exposure to beryllium in
the workplace and to determine whether workers have beryllium sensitization
or CBD.
1. ENGINEERING CONTROLS
Employers should use appropriate engineering controls and work practices to
ensure that worker exposures to beryllium are maintained below the current
OSHA PELs to the extent feasible. The following engineering controls and
practices should be used by employers:
* enclose processes;
* design and install appropriate local exhaust ventilation;
* use vacuum systems in machining operations;
* use pellets instead of powders wherever possible;
* use product substitution where possible;
* minimize the number of workers who have access to areas where there
is a potential for beryllium exposure;
* monitor employee exposures to airborne beryllium dust and fume, using
personal sampling techniques, on a regular basis to ensure that
exposures are below the PELs and that proper respiratory protection is
being used where necessary.
2. WORK PRACTICES TO REDUCE BERYLLIUM EXPOSURE
Employers should ensure that employees use the following safe practices to
reduce their exposure to beryllium:
* use high-efficiency particulate air (HEPA) vacuums to clean equipment
and the floor around their work areas;
* do not leave a film of dust on the floor after the water dries if a
wet mop is used to clean;
* do not use long vacuum hoses and do not loop the hoses that are used;
* do not disconnect or disable the vacuum system during any machining
operation;
* never use compressed air to clean parts or working surfaces;
* avoid prolonged skin contact with beryllium particulate; and
* do not allow workers to eat, drink, smoke, or apply cosmetics at their
work stations.
3. HYGIENE AND PERSONAL PROTECTIVE CLOTHING
OSHA is aware of CBD cases that have occurred among family members of
beryllium-exposed workers. To reduce "carry-home" exposures, employers
should provide showers, clean work clothes, and clean areas for storing street
clothes. Protective clothing should be provided to employees who work in
areas where beryllium-containing powders are used and where there is a
potential for spills. In addition, employers should ensure that employees:
* change into work uniforms before entering their work area;
* place their uniforms in a labeled bin with a cover at the end of the work
shift;
* shower and change into street clothes prior to leaving the facility;
* wash their face, hands, and forearms before eating, smoking, or applying
cosmetics;
* keep their work clothes as clean as possible during the workshift;
wipe off their shoes before leaving the work area; and
* do not wear their work uniform (including their work shoes) outside of
the facility.
4. RESPIRATORY PROTECTION
Recent data suggest that exposures to beryllium even at levels below the 2
micrograms/m3 PEL may have caused CBD in some workers. Therefore,
employers should consider providing their beryllium-exposed workers with
air-purifying respirators equipped with 100-series filters (either N-, P-, or
R-type) or, where appropriate, powered air-purifying respirators equipped
with HEPA filters, particularly in areas where material containing beryllium
can become airborne.
5. TRAINING
Employers should give employees exposed to beryllium training and
information about the following items:
* material safety data sheets (MSDSs) for beryllium;
* the fatal lung disease that may occur as a result of exposure;
* the availability of the BeLPT blood test to determine whether an
exposed worker has become sensitized to beryllium;
* the potential for developing lung cancer as a result of exposure;
* the importance of avoiding skin contact;
* the engineering controls the employer is using to reduce worker
exposures to beryllium;
* specific work practices that can be used to reduce exposure to
beryllium;
* the use of appropriate protective equipment, including the use of
respirators;
* the results of any industrial hygiene sampling for levels of beryllium in
the workplace; and
* a copy of this Hazard Information Bulletin.
6. HEALTH SCREENING METHODS FOR BERYLLIUM
SENSITIZATION AND CHRONIC BERYLLIUM DISEASE
To the Employer:
Employers should consider sending beryllium-exposed employees to a
physician or other licensed health care professional to be evaluated for
beryllium sensitization or the presence of CBD. The screening examination for
CBD usually begins with a chest x-ray and a blood test for beryllium
sensitization, namely, the BeLPT, plus any further evaluation considered
appropriate by the health care professional. The blood test can detect an
adverse health response to beryllium exposure earlier than breathing tests or
chest x-rays can. The BeLPT is not routinely done in most medical
laboratories; however, the health care professional may order this test from
any laboratory that has overnight courier service to one of the Medical
Research Centers listed below. If a worker is sent to a health care
professional for health screening, a copy of this Hazard Information Bulletin
should accompany the employee.
To the Employee:
If you work in a place where beryllium is used and have developed any of the
symptoms listed below, you should inform your health care professional of
your past beryllium exposure, or seek information from a health care
professional who specializes in occupational lung diseases to determine
whether you may have developed CBD:
* unexplained cough,
* shortness of breath,
* fatigue,
* weight loss or loss of appetite,
* fevers, and/or
* skin rash.
If you do not have any of the above symptoms but are concerned that you may
have become sensitized to beryllium, you should inform your health care
professional that you would like to be tested with the blood BeLPT. Take a
copy of this Hazard Information Bulletin with you.
BLOOD TESTING FOR BERYLLIUM SENSITIZATION
Only the three medical research centers and the one laboratory listed below
currently offer the blood test to identify beryllium-sensitized workers as
indicated by a positive blood BeLPT. As other research centers and
laboratories develop the capacity to screen workers for beryllium
sensitization, they will be added to the list.
Medical Research Centers
Cleveland Clinic Foundation
9500 Euclid Avenue, L-15
Cleveland, Ohio 44195
phone: (800) 628-6816
Division of Environmental and Occupational Health Sciences
National Jewish Medical and Research Center
Denver, Colorado 80206
phone: (303) 398-1722
Pulmonary Immunology Laboratory
Hospital of the University of Pennsylvania
421 Curie Blvd.
844 BRB II/III
Phliadelphia, Pennsylvania 19104
phone: (215) 573-9875
Testing Laboratory
Specialty Laboratories, Inc.
2211 Michigan Avenue
Santa Monica, California 90404-3900
phone: (800) 421-4449
http://www.osha.gov
http://www.dol.gov
Occupational Safety & Health Administration
200 Constitution Avenue, NW
Washington, DC 20210
USA
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