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Standard Interpretations 

02/06/1997 - The dental industry's concerns regarding 

compliance with certain provisions of the Hazard Communication 

Standard (HCS). 

Standard Interpretations - Table of Contents

• Standard Number: 1910.1200

February 6, 1997 

Linda M. Chatwin, Esq. 

General Counsel 

Ultradent Products Incorporated 

505 West 10200 South 

South Jordan, Utah 84095 

Dear Ms. Chatwin: 

The Occupational Safety and Health Administration (OSHA) has, over the past year and a 

half, undergone extensive discussions with the American Dental Trade Association (ADTA) 

in an attempt to resolve the dental industry's concerns regarding compliance with certain 

provisions of the Hazard Communication Standard (HCS). 

One such concern was the necessity of MSDSs for dental devices, as these devices are 

already regulated under Food and Drug Administration (FDA) labeling provisions. As fully 

explained in the enclosed letter to Mr. Thomas Fise of the American Dental Trade 

Association (ADTA), OSHA has determined that MSDSs are required for dental devices 

which are not exempt from coverage under the "article" or "consumer products" provisions of

the HCS. 

As you correctly note, the agency's stay of enforcement was lifted on December 16, 1996, 

and the dental industry is therefore expected to comply with the provision of the HCS. 

OSHA does not envision a change in its position on this issue, which resulted from a 

thorough and exhaustive analysis of the issues raised by the ADTA. If we may be of further 

assistance, please do not hesitate to contact us. 

Sincerely, 

Stephen Mallinger, Acting, Director 

Office of Health Compliance Assistance 

December 11, 1996 

Ms. Ruth McCaulley 

OSHA Office of Health Compliance Assistance 

200 Constitution Avenue N.W.

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Washington D.C. 20210 

Dear Ms. McCaulley: 

I would appreciate receiving an update of OSHA's position regarding MSDS requirements 

for dental devices. I understand that the 120 day stay of enforcement as to FDA regulated 

dental devices has now passed. Please let me know whether OSHA is now in a position to 

make this stay permanent or whether other solutions for the MSDS problem in the dental 

field are at hand. 

I appreciate your help and response in this matter. 

Thank you. 

Sincerely, 

Linda M. Chatwin, Esq. 

General Counsel 

January 7, 1997 

Thomas F. Fise, Esq. 

Special Council, Regulatory Affairs for the American Dental Trade Association 

4900 B South 31ST Street 

Arlington, Virginia 22206 

Dear Mr. Fise: 

Thank you for your letter of November 21, addressed to Ms. Ruth McCully of my staff and 

sent as a follow up to the October 11 meeting between yourself, representatives of the 

Occupational Safety and Health Administration (OSHA), Office of Solicitor (SOL), and the 

Food and Drug Administration (FDA). This letter provides a recapitulation of the Hazard 

Communication Standard (HCS) issues that have been under discussion with the ADTA, the 

Agency's conclusions, and brief explanations for those conclusions. 

FDA and OSHA Jurisdiction 

One of the ADTA's issues concerned the perceived overlap between FDA and OSHA in the 

regulation of dental devices. Throughout this process, we have worked closely with FDA to 

ensure that the integrity of jurisdictional boundaries was respected and maintained, and we 

hope that, with the assistance of the FDA representatives, we were able to provide you with a 

better understanding of our respective jurisdictional boundaries regarding dental devices. 

OSHA's jurisdiction is limited to employees' exposure due to handling or use of hazardous 

chemicals in the workplace. FDA is concerned with product efficacy and patient safety. 

Given these different statutory and regulatory mandates, OSHA and FDA were unable to 

identify any clear areas of regulatory overlap. One issue of specific concern to the ADTA 

was labeling. We informed you that dental devices which require labeling under FDA 

regulations are exempt from OSHA's HCS labeling requirements (29 CFR 1910.1200(b)(5)). 

In your December 12 correspondence, we note your position that Material Safety Data Sheets 

(MSDSs) fall within FDA's definition of labeling. As we have discussed in earlier meetings, 

this is unfounded. As the FDA has neither prescribed nor enforced regulations requiring 

manufacturers to transmit information on the hazards of chemicals to downstream users by 

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means of MSDS's, FDA's labeling provision for Dental Devices is not duplicative and would 

not meet the criteria of a (4)(b)(1) pre-emption of the OSH Act. 29 USC Section 653(b)(1). 

This is further discussed in the preamble to the HCS final rule. 59 Federal Register 6126, 

6149-50 (Feb. 9, 1994) (package inserts accompanying FDA regulated dental devices cannot 

be considered to be material safety data sheets (MSDS)). 

Dental Devices Covered by HCS 

Another issue concerned the identification of dental devices that are covered by the HCS. In 

our communication of August 22, 1995, from Assistant Secretary Joseph A. Dear, we made a 

commitment to "provide further compliance assistance to the ADTA to ensure that the 

industry is fully applying all the existing HCS exemptions." OSHA worked closely with 

FDA in this effort. We conducted a broad hazard determination of the FDA's defined classes 

of dental devices, beginning with a review of FDA regulation, 21 CFR 872, Dental Devices. 

Next, we excluded devices that failed to meet the HCS definition of a hazardous chemical. 

We also excluded those devices that met the "article" and "consumer product" exemptions 

under the HCS (29 CFR 1910.1200(b)(6)). 

In this regard, articles are exempt under the HCS if they are "a manufactured item other than 

a fluid or particle: (i) which is formed to a specific shape or design during manufacture; (ii) 

which has end use function(s) dependent in whole or in part upon its shape or design during 

end use; and (iii) which under normal conditions of use does not release more than very small

quantities, e.g., minute or trace amounts of a hazardous chemical (as determined under 

paragraph (d) of this section), and does not pose a physical hazard or health risk to 

employees." If a dental device does not potentially release hazardous chemicals during 

normal use, it would be considered an article, e.g., an endosseous implant, a dental chair, a 

dental handpiece, an x-ray unit, all would be considered articles and would be exempt from 

the HCS. If hazardous chemicals are released during normal use, the manufacturer is required 

to create an MSDS. 

Likewise, consumer products are exempt, "where the employer can show that it is used in the 

workplace for the purpose intended by the chemical manufacturer or importer of the product, 

and the use results in a duration and frequency of exposure which is not greater than the 

range of exposures that could reasonably be experienced by consumers when used for the 

purpose intended." The standard requires the employer to ascertain whether the workplace 

use is more frequent or of longer duration than would be expected in normal consumer use. 

Exposures in workplace situations can be greater than a consumer would experience, and 

thus, the need increases for additional information for employee protection. 

In order for the exemption to be applied, the consumer product must have the same chemical 

composition, intended use, and potential for exposure as a specific dental device. In this 

regard, let me stress that to qualify for the consumer product exemption, the Standard 

provides two criteria which must be met. These are that the dental device, 1) must be used by 

the consumer and dental professional in the manner intended by the manufacturer, and 2) is a 

consumer product as that term is defined in the Consumer Product Safety Act, 15 U.S.C. 

2051 et seq. In your November 21 correspondence, we note that although consumer products 

were identified which contain chemicals also found in dental devices, the items fail to meet 

criteria for a consumer product under the HCS. For example, stove-gasket cement and joint 

crack sealant have a different intended use by a consumer than the use of porcelain powder 

by a dentist or a dental technician. 

Our hazard determination effort generated two tables of dental devices referenced by class 

(enclosed). The first table identifies "Dental Devices Which Require Manufacturer's 

Determination for Presence of Hazardous Chemicals and, if Present, Would Then Require a 

MSDS." The second table identifies "Dental Devices Not Covered by the Hazard 

Communication Standard." Please bear in mind that these lists represent a preliminary hazard 

determination performed on a broad category of dental devices. The device manufacturer or 

importer maintains the responsibility and right to perform a more specific hazard 

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determination to decide whether or not a particular device may be considered a hazardous 

chemical(s) under the HCS. The HCS requires that a MSDS be generated only if the device 

contains a hazardous chemical as shown by the manufacturer's or importer's hazard 

determination. 

Small Quantity Use 

ADTA was also concerned regarding the HCS coverage for dental devices that are often used 

in relatively small quantities. As proposed by Assistant Secretary Joseph A. Dear in his letter 

of November 22, 1995, this issue was referred to the National Advisory Committee on 

Occupational Safety and Health (NACOSH) Hazard Communication Workgroup. This 

Workgroup was established in response to The President's Report, "The New OSHA," issued 

in May, 1995, and was composed of professionals with expertise in hazard communication 

representing small and large businesses, unions, state governments, and consulting firms (see 

pages 13 and 14 of the enclosed report for a listing of Workgroup members.) The mission of 

the Workgroup was to provide OSHA with recommendations to simplify MSDSs, reduce the 

amount of required paperwork, improve the effectiveness of worker training, and revise 

enforcement policies so that they focus on the most serious hazards. In all our meetings and 

correspondence we invited and urged ADTA's participation in this process. In your absence, 

we presented to the NACOSH Hazard Communication Workgroup the "small quantity 

issues" on ADTA's behalf. The NACOSH Workgroup issued its report on September 12, 

with their findings and recommendations. The "small quantity issue" is discussed on pages 

84 through 86 of the report. The Workgroup's conclusion on this issue follows: 

"...that a small quantity exemption that could be uniformly applied in all workplaces could 

not be identified. In addition, workgroup members agreed that all workers deserve equal 

protection, and they could not quantify any small quantity exception at this time that would 

balance the above factors appropriately. Therefore, the workgroup does not agree that an 

across-the-board small quantity exemption should be developed, and further believes that 

such an exemption could actually increase the compliance burdens associated with the 

standard." 

Please remember, that the HCS is an information transmittal standard triggered whenever a 

substance is covered as a hazardous chemical. The fact that a chemical poses a potential 

hazard is different from the concept of risk. The risk that a chemical presents is dependent 

upon the concentration, frequency, and duration of exposure. The standard requires the 

development of MSDSs based on the intrinsic properties (i.e., corrosivity, irritation, 

sensitization, etc.) of a hazardous chemical, not on predictions about the level of risk 

experienced by particular employees. 

Transmission of MSDSs 

Another concern discussed was the transmission of MSDSs for dental devices by 

manufacturers, importers, or distributors. In our October 11 meeting, we discussed options 

that would reduce compliance costs. The HCS requires MSDSs to be sent with the initial 

shipment of a hazardous chemical and when the MSDS is updated. An alternative method of 

sending MSDSs to downstream users is by electronic transmission. For example, MSDSs 

may be transmitted by available technology such as telefaxes, electronic bulletin boards, 

Internet, and CD-ROM/floppy disks to eliminate the need to send paper copies. Both the 

MSDS sender and receiver must be equipped and agreeable to the electronic transmission. 

We have been informed that there are a number of manufacturers in a variety of industries 

that are successfully using electronic transmission of MSDSs. 

Conclusions 

In summary, based upon our discussions, the information provided by FDA and ADTA and 

our extensive review of the issues, the Agency has concluded the following: 

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(1) HCS-covered dental devices are exempt from HCS labeling requirements (but not exempt 

from MSDS requirements) whenever there is an existing FDA labeling requirement for that 

device. 

(2) Dental devices meeting the definition of a hazardous chemical are covered by the HCS. 

The enclosed tables represent a broad hazard determination for classes of dental devices 

rather than for specific items in each class. Manufacturers or importers of HCS-covered 

dental devices have the responsibility and right to conduct a specific hazard determination for 

specific dental devices. 

(3) Employees who handle dental devices covered under the HCS are entitled to the 

protections provided under the Standard. The HCS requires that these employees have access 

to information regarding the hazards of the chemicals to which they are exposed, independent 

of the risk or quantity of the chemical present. 

(4) Electronic transmission of MSDSs can reduce compliance costs and is an accepted 

alternative to sending paper copies. 

Finally, as you know, the Agency issued a temporary enforcement stay on May 16. This 

allowed OSHA the opportunity to conduct a broad hazard determination for the FDA classes 

of dental devices. During this interval, NACOSH proceeded with its task of reviewing 

pertinent HCS issues and published its final report. In addition, the stay permitted OSHA to 

carefully consider all other issues raised by ADTA. We believe that with the assistance of the 

FDA, ADTA, and NACOSH, the Agency has conducted a thorough evaluation of these 

issues within the parameters of the HCS and the OSH Act. As a result, OSHA ended its 

temporary enforcement stay on dental devices effective December 16. 

We appreciate your cooperation throughout our discussions and the industry perspective you 

presented. We valued your participation in the process and your interest in worker safety and 

health. 

Sincerely, 

John Miles, Jr., Director 

Directorate of Compliance Programs 

Enclosures 

Table No. 1. Dental Devices Which Required Manufacturer's Determination for Presence of 

Hazardous Chemicals, and if Present, Would Then Require a MSDS 

FDA Class No. Device Class Name 

872.3050 Amalgam alloy 

872.3060 Gold based alloys and precious metal alloys for clinical 

 use 

872.3300 Hydrophillic resin coating for dentures 

872.3310 Coating material for resin fillings 

872.3690 Tooth shade resin material 

872.3200 Resin tooth bonding agent 

872.3260 Cavity Varnish 

872.3600 Partially fabricated denture kit 

872.3700 Dental mercury 

872.3710 Base metal alloy 

872.3660 Impression material 

872.3645 Subperiosteal implant material 

872.6200 Base plate shellac 

872.6660 Porcelain powder for clinical use 

872.3750 Bracket adhesive resin and tooth conditioner 

872.3760 Denture relining, repairing, or rebasing resin 

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872.3765 Pit and fissure sealant and conditioner 

872.3770 Temporary crown and bridge resin 

872.3250 Calcium Hydroxide cavity liner 

872.3820 Root canal filling resin 

872.3930 Tricalciun phosphate granules for dental bone repair 

Table No. 2 Dental Devices Not Covered by the Hazard Communication Standard 

FDA Class No. Device Class Name 

872.3275 Denture Cement 

872.3640 Endosseous implant 

872.3400 Karaya and sodium borate with or without acacia denture 

 adhesive 

872.3410 Ethylene oxide homopolymer and/or carboxymethyl-cellulose 

 sodium denture adhesive 

872.3420 Carboxymethylcellulose sodium and cationic polyacrylamide 

 polymer denture adhesive 

872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive 

872.3480 Polyacrylamide polymer (modified cationic) denture 

 adhesive 

872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid 

 copolymer, and carboxymethlcellulose (NACMC) denture 

 adhesive 

872.3490 Carbomethylcellulose sodium and/or polyvinylmethylether 

 maleic acid calcium-sodium double salt denture adhesive 

Standard Interpretations - Table of Contents

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