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Standard Interpretations 02/06/1997 - The dental industry's concerns regarding compliance with certain provisio ns of the Hazard Communication Standard (HCS).

Standard Interpretations

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• 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 Administra tion (OSHA) has, over the past year and a half, undergone extensive discussions with the American Dental Trad e Association (ADTA) in an attempt to resolve the dental indust ry's concerns regarding co mpliance with certain p rovisions of the Hazard Comm unication Standard (HCS).
One such concern was the necessity of MSDSs for dental devices, as these devices are already regulated under Food and Drug Admini stration (FDA) labeling provisions. As fully explained in the enclosed le tter to Mr. Thomas Fise of the American Dental Trade Association (ADTA), OSHA has determined th at MSDSs are required for dental devices which are not exempt from coverage under the "article" or "consumer products" provisions o f 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 pos ition 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 he sitate to contact us.
Sincerely,

Stephen Mallinger, Acting, Director Office of Health Compliance Assistance

December 11, 1996
Ms. Ruth McCaulley OSHA Office of Health Co mpliance 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 OS HA is now in a position to make this stay permanent or whether other so lutions 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 meeti ng between yourself, re presentatives of the Occupational Safety and Health Administration (OSHA), Office of Solicitor (SOL), and the Food and Drug Administration (FDA). This le tter provides a recapitulation of the Hazard Communication Standard (HCS) issues that have been under discussion with the ADTA, the Agency's conclusions, and brief e xplanations for those conclusions.

FDA and OSHA Jurisdiction
One of the ADTA's issues concerned the per ceived overlap between FDA and OSHA in the regulation of dental devices. T hroughout this process, we have worked closely with FDA to ensure that the integrity of jurisdictional bounda ries was respected and maintained, and we hope that, with the assistance of the FDA represent atives, we were able to provide you with a better understanding of our respective jurisdic tional boundaries regarding dental devices. OSHA's jurisdiction is limite d to employees' exposure due to handling or use of hazardous chemicals in the workplace. FDA is concerne d 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 defin ition of labeling. As we have di scussed in earlier meetings, this is unfounded. As the FDA has neither prescribed nor enforced regulations requiring manufacturers to transmit information on th e hazards of chemicals to downstream users by 

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...means of MSDS's, FDA's labeling provision for Dent al Devices is not duplicative and would not meet the criteria of a (4)(b)(1) pre-emp tion 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 accompanyi ng FDA regulated dental devices cannot be considered to be material safety data sheets (MSDS)).
Dental Devices Covered by HCS

Another issue concerned the iden tification of dental devices that are covered by the HCS. In our communication of August 22, 1995, from Assistant Secretary Jo seph A. Dear, we made a commitment to "provide further compliance assi stance to the ADTA to ensure that the industry is fully applying al l 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 regulati on, 21 CFR 872, Dental Devices. N ext, we excluded devices that failed to meet the HCS definition of a hazardous chemical. We also excluded those devices that met th e "article" and "consumer product" exemptions under the HCS (29 CFR 1910.1200(b)(6)).
In this regard, articles are exempt under the HC S 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 w hole 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 tr ace amounts of a hazardous chemical (as determined under p aragraph (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 implan t, a dental chair, a dental handpiece, an x-ray unit, all would be considered artic les 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 th e 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 p urpose intended." The standard requires the emp loyer 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 great er than a consumer would experience, and thus, the need increases for additiona l 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 expos ure as a specific dent al device. In this regard, let me stress that to qualify for the consumer product ex emption, the Standard p rovides two criteria which must be met. These ar e 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 ta bles of dental devices referenced by class (enclosed). The first table identifies "Den tal Devices Which Require Manufacturer's Determination for Presence of Hazardous Chemicals and, if Present, Would Then Require a MSDS." The second table identifies "D ental Devices Not Covered by the Hazard Communication Standard." Please bear in mind th at 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 par ticular 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 show n by the manufacturer's or importer's hazard determination.
Small Quantity Use
ADTA was also concerned regarding the HCS cove rage for dental devices that are often used in relatively small qua ntities. As proposed by Assistant Secr etary Joseph A. Dear in his letter of November 22, 1995, this issue was re ferred to the National Advisory Committee on Occupational Safety and Health (NAC OSH) Hazard Communication Workgroup. This Workgroup was established in response to The Pr esident's Report, "The New OSHA," issued in May, 1995, and was composed of professiona ls with expertise in hazard communication representing small and large businesses, unions , state governments, and consulting firms (see p ages 13 and 14 of the enclosed report for a listing of Workgroup members.) The mission of the Workgroup was to provide OSHA with recomme ndations to simplify MSDSs, reduce the amount of required paperwork, improve the effect iveness 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 urge d ADTA's participation in th is process. In your absence, we presented to the NACOSH Hazard Communication Workgroup the "small quantity issues" on ADTA's behalf. The NACOSH W orkgroup 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 coul d be uniformly applied in all workplaces could not be identified. In addition, workgroup members agreed that all workers deserve equal p rotection, and they could not quantify any s mall quantity exception at this time that would balance the above factors appropriately. Th erefore, 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 chemi cal poses a potential hazard is different from the concept of risk. Th e risk that a chemical presents is dependent upon the concentration, frequency, and dura tion of exposure. The standard requires the development of MSDSs based on the intrinsi c properties (i.e., corrosivity, irritation, sensitization, etc.) of a haza rdous chemical, not on predicti ons about the level of risk experienced by particular employees.

Transmission of MSDSs

Another concern discussed was the tran smission 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 re quires 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 el ectronic transmission. For example, MSDSs may be transmitted by available technology such as telefaxes, elec tronic 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 num ber of manufacturers in a variety of industries that are successfully using elec tronic transmission of MSDSs.

Conclusions
In summary, based upon our discussions, th e 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 requi rements (but not exempt from MSDS requirements) whenever there is an existing FDA labeling requirement for that device.
(2) Dental devices meeting th e definition of a hazardous chemical are covered by the HCS. The enclosed tables represent a broad hazard determination for clas ses of dental devices rather than for specific items in each cl ass. Manufacturers or importers of HCS-covered dental devices have the respons ibility and right to conduct a specific hazard determination for specific dental devices.
(3) Employees who handle dental devices c overed under the HCS are entitled to the p rotections provided under the Standard. The HCS requires that these em ployees have access to information regarding the hazards of the chemi cals 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 sendi ng paper copies.
Finally, as you know, the Agency issued a temporary enforcement stay on May 16. This allowed OSHA the opportunity to conduct a broa d hazard determination for the FDA classes of dental devices. During th is interval, NACOSH proceeded with its task of reviewing p ertinent HCS issues and published its final re port. In addition, the stay permitted OSHA to carefully consider all other issu es 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 discus sions and the industry perspective you p resented. We valued your partic ipation in the process and your in terest in worker safety and health.
Sincerely,

John Miles, Jr., Director Directorate of Compliance Programs

Enclosures
Table No. 1. Dental Devices Which Require d Manufacturer's Determination for Presence of Hazardous Chemicals, and if Presen t, 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 Covere d 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

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