The Globally Harmonized System Unveiled (Regulatory Standards CE)

Renata Budny, MBA, MDT, CDT

December 2018 Issue - Expires December 31st, 2019

Inside Dental Technology

Abstract

Unlike medicine or dentistry, the dental laboratory profession has been vastly unregulated for many years. However, this trend is changing. In recent years, more emphasis is being placed on the health risks associated with dental products; thus, the manufacture and safety of dental goods has become subject to increased scrutiny. To protect public health and the safety of workers, numerous national and international agencies have begun enforcing new or, in some instances, improved regulatory standards covering product labeling systems.

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The more that products have been developed and transported around the world, the more obvious it has become that not much was known about their safety. In different countries, workers and consumers were subject to each country's laws and regulations and often had no understanding of what types of dangers were posed by imported products. In one country, a product could be considered carcinogenic (cancer-causing), whereas in another it was not. As new goods were introduced to national and international markets, it was impossible for one nation to identify and regulate all the hazardous products. The United Nations Economic Commission for Europe clearly identified this risk: "Chemicals, through the different steps from their production to their handling, transport, and use, are a real danger for human health and the environment. People of any ages, from children to elderly, using many different languages and alphabets, belonging to various social conditions, including illiterates, are daily confronted to dangerous products (chemicals, pesticides, etc.)"1

The idea of creating one synchronized warning system started with bringing existing systems together and creating a single, globally harmonized structure to address the classification of chemicals, labels, and safety data sheets in the workplace, transportation, and for the end consumer. At first, product classification and labeling harmonization were utilized for physical hazards and acute toxicity in the transport sector based on the work of the United Nations Economic and Social Council's Committee of Experts on the Transport of Dangerous Goods (UNCEDTG). However, the workplace and consumer sectors were nowhere near the standards that transportation adopted.2

Worldwide Historical Perspective

Development of a worldwide system for hazardous communication that would encompass as many nations as possible emerged in 1992 during the United Nations Conference on Environment and Development (UNCED) in Brazil, where the mandate set the scope of the Globally Harmonized System (GHS). Based on further research, the mandate was examined and refined to distinguish GHS parameters.3 Three final parameters agreed upon included:

Parameter 1:The GHS covers all hazardous chemicals. The mode of the application of the hazard communication elements of the GHS (eg, labels, safety data sheets) may vary by product category or stage in the lifecycle. Target audiences for the GHS include consumers, workers, transport workers, and emergency respondents.

Parameter 2: The mandate for development of a GHS does not include the establishment of uniform test methods or promotion of further testing to address adverse advance health outcomes.

Parameter 3: In addition to animal data and valid in vitro testing, human experiences, epidemiological data, and clinical testing provide important information that should be considered in the application of the GHS.3

Ultimately, in 2003, the United Nations (UN) adopted the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and made it available for all countries to adopt. The GHS included criteria for the classification of health, physical, and environmental hazards, as well as what information should be included on labels of hazardous chemicals and safety data sheets.

The Sub-Committee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS Sub-Committee) is responsible for maintaining, promoting implementation, and providing guidance and support to the GHS. The GHS Sub-Committee also regularly revises and updates the GHS to reflect national, regional, and international laws concerning its implementation as well as the experiences of those classifying and labeling. Since 2002, the GHS has been updated every 2 years, and its seventh revised edition was published in 2017.

Even though this system was promoted for worldwide implementation as soon as possible upon its 2003 adoption, today the GHS is implemented in most but not all countries.*

United States Historical Perspective

In the United States, the workplace system is regulated by the Department of Labor, specifically by the Occupational Safety and Health Administration (OSHA). Hence, it was OSHA that implemented GHS in the workplace in the form of the Hazard Communication Standards (HCS), revised and published in the Federal Registrar in 2012. The Hazard Communication Standard (HCS) was set in line with the third revised edition of GHS, and it became mandatory in 2015.

The GHS system was also fully implemented in United States national and international transport of dangerous goods (including maritime, air, and land transport of food and agriculture). The agency responsible for implementation of GHS for transport of dangerous goods is the Department of Transportation (DOT): Pipeline and Hazardous Materials Safety Administration through the Hazardous Materials Regulations (Title 49 CFR Parts 100-185) legislature.6 However, the implementation of GHS for consumer products is much more complex. The agency responsible for consumer products safety is the Consumer Product Safety Commission (CPSC); two related legislatures are the Consumer Product Safety Act and Federal Hazardous Substances Act.

According to OSHA, the current Hazard Communication Standard (HCS) is fully aligned with the GHS. The HCS requires the information about chemicals used in a workplace to be available to and understandable by all employees through labels and safety data sheets, as well as through employee training. Furthermore, the manufacturers and importers of chemicals are also required to provide labels and safety data sheets to communicate hazard information to their customers.

The latest update to the HCS delivers a logical and easily comprehensible method of classifying chemicals and communicating hazard data on labels and safety data sheets. It helps reduce trade barriers, results in productivity improvements, and provides cost savings for American businesses.7

The major changes implemented within the Hazard Communication Standard include:

Hazard classification: Specific criteria for the classification of health and physical hazards, as well as classification of mixtures, are provided.

Labels: Chemical manufacturers and importers are required to provide a label that includes a harmonized signal word, pictogram, and hazard statement for each hazard class and category. Precautionary statements must also be provided (Figure 1 and Figure 2).

Safety data sheets (SDSs): These now have a specified 16-section format (Figure 3).

Information and training: Employers were required to train workers by December 1, 2013, on the new label elements and safety data sheets format to facilitate recognition and understanding.7

The changes implemented in the HCS continue to bridge the United States with the GHS of Classification and Labeling of Chemicals (GHS). As far as the old standard allowed chemical manufacturers and importers to include hazard information on labels and material safety data sheets in the format of their choice, the current modification agrees on a set of harmonized criteria for classifying chemicals according to their health and physical hazards, and identifies hazard communication elements for labeling and safety data sheets. The latest changes improve the quality and consistency of hazard communication in the workplace, enhance comprehension and reduce confusion of hazards, provide quicker and more efficient access to information on the safety data sheets, and result in safer handling and use of chemicals.

These increased safety and health efforts also help avoid injuries, illnesses, and fatalities among American workers and improve trade conditions for chemical manufacturers. The savings of more than $475 million bring enhancements in productivity, in fewer safety data sheet and label updates, and in simpler hazard communication training. The improvements then continue by reducing the trade barriers by harmonizing with systems around the world. According to the 2012 OSHA Hazard Communication report, "The Hazard Communication Standard in 1983 gave the workers the ‘right to know,' but the new Globally Harmonized System gives workers the ‘right to understand.'"8 The benefits of the new standard encompassed over 43 million employees exposed to hazardous chemicals in more than 5 million workplaces across the United States. In the 2012 report, this modification was expected to prevent over 500 workplace injuries and illnesses and 43 fatalities annually.8

HCS and Dental Laboratories

Dental laboratories, just as any other businesses, are under the jurisdiction of OSHA and must adhere to health and safety protocols that include proper labeling and hazard communication. Being that there are over 50 OSHA standards that pertain to the dental laboratory industry, the Hazard Communication Standard that deals with Toxic and Hazardous Substances is designated as 29 CFR 1910.1200. This standard has been updated to align with the GHS, Revision 3. It was issued in the Federal Register on March 26, 2012, and became effective on May 25, 2012. By December 1, 2013, all employers were required to train workers on the new label elements and safety data sheet format. According to OSHA's Quick Fact Sheet: Hazard Communication Standard Final Rule, "The transmittal of information is to be accomplished by means of comprehensive hazard communication programs, which are to include container labeling and other forms of warning, safety data sheets and employee training."9

From a regulatory perspective, some of the dental laboratory employer's responsibilities include the preparation, implementation, and maintenance of the written Exposure Control Plan with annual review, chemical hygiene plan (CHP), hazard identification, and employee information and training. Similarly, the dental laboratory employees have to comply with training, hazard identification, understanding the labels and signs, and reporting any exposure to bloodborne pathogens and hazardous chemicals, among other duties. The communication between employers and employees involves training upon hire and the availability of current safety data sheets (SDSs) and labels on products readily available to all employees and in emergency cases to emergency respondents.

According to Bennett Napier, Chief Staff Executive of the National Association of Dental Laboratories (NADL), OSHA inspections have increased slightly over the years. Public data offered on the OSHA inspection website lists 31 OSHA inspections from 2017 and earlier 2018. Some dental laboratories had more than one inspection during that time period, so, while the number of dental laboratories inspected is modest, it indicates an upward trend. States where inspections have occurred include Alabama, Alaska, Florida, Hawaii, Minnesota, New York, North Carolina, Oregon, and Virginia. Thirteen of the 19 were in Minnesota; however, several of the ones that occurred there were planned visits where dental laboratories asked for OSHA to visit as part of monitoring compliance.

According to Napier, those dental laboratories that were cited for not complying with OSHA Standards 29 CFR 1910.1200 received moderate or no financial penalties. One-third of the inspections were triggered by complaints. Most fines received by dental laboratories averaged between $1,000 to $2,000. The laboratories penalized with $10,000 fines were charged based on multiple violations; oftentimes, though, the fines were reduced upon appeal. OSHA fines can range from $100 to over $100,000 (Figure 4), and states that implement their own OSHA plans must comply with minimum penalty levels set by federal OSHA.10-14

Education and Training

Regulatory compliance in dental laboratories is often overseen by designated employees. Laboratories can also seek information directly from the OSHA website, which provides clarifications and examples on many topics. Created as a national network of nonprofit organizations authorized by OSHA to deliver occupational safety and health training to public and private sector workers, supervisors, and employers on OSHA's behalf, OSHA Training Institute (OTI) Education Centers can provide specialized training for any profession. The OTI Education Centers can deliver training at OSHA sites located throughout the country or directly to companies at their locations on a contract basis. In 2016, OTI Education Centers instructed 52,433 trainees.15

As a boutique industry, the dental laboratory profession in the United States established strong ties with the NADL, the National Board for Certification in Dental Laboratory Technology (NBC), and the Foundation for Dental Laboratory Technology (FDLT). As Bob Savage, the current NADL president, says, "Through the combined efforts, the three organizations are working diligently every day to advance the role of the dental technician, foster an environment of formal education, and administer professional standards for certification."16

To acknowledge its closely aligned compliance with OSHA Standards, a dental laboratory can become a Certified Dental Laboratory (CDL) through NBC. The CDL is a voluntary, national certification program which requires an initial written application with one independent review ($300 fee), annual renewal fee ($200), and 5-year revalidation application ($300 fee).17 The CDL certification adheres to the strict infection control; health, safety, and case management standards; as well as a Certified Dental Technician (CDT) being on the premises. According to NBC, "CDL standards closely align with legal requirements with the OSHA standards for hazard communication and bloodborne pathogen exposure control that are laws for employers today. By implementing the equipment elements of the CDL standard, your laboratory will be better prepared for an OSHA audit."18 The NBC also supports CDLs by offering approved continuing education courses taking place across the country on a variety of topics. Currently, there are 193 CDLs in the United States certified by NBC.19

Training in health and safety standardsincluding training in proper labeling of products utilized in dental laboratoriescan also be provided by private consulting firms, some of which are listed on the NADL website.

Conclusion

Today, the dental laboratory profession is no longer excluded from regulations. On the contrary, the profession has to comply with a vast number of standards pertaining to proper product identification. The health and safety of patients, employees, employers, and manufacturers has become a priority endorsed by all industry leaders. Compliance is a small price to pay for the peace of mind knowing that current and future generations of patients and workers are protected from diseases and deaths caused by improperly marked and handled products.

About the Author

Renata Budny, MBA, MDT, CDT
Associate Professor
Chair, Restorative Dentistry
New York City College of Technology
Brooklyn, NY

References

1. UNECE. About the GHS. The United Nations Economic Commission for Europe. http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html.  Accessed July 19, 2018. 

2. UNECE. Historical Background. The United Nations Economic Commission for Europe. http://www.unece.org/trans/danger/publi/ghs/histback_e.html 

3. UN. (2009). Globally Harmonized System of Classification and Labeling of Chemicals(GHS). United Nations. Economic Commission for Europe. Secretariat. 3 ed. New York and Geneva. https://books.google.pl/books?id=V1W5NDcXa8sC&printsec=frontcover&hl=pl#v=onepage&q&f=false. Accessed July 19, 2018.

4. CRS. The UN Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  Chemical Inspection and Regulation Services.http://www.cirsreach.com/GHS/Index_UN_GHS_Global_GHS_Implementation.html. Updated July 2014. Accessed July 18, 2018.

5. UNECE. GHS Implementation. The United Nations Economic Commission for Europe. http://www.unece.org/trans/danger/publi/ghs/implementation_e.html#c25752. Accessed July 19, 2018.

6. Wikipedia. Globally Harmonized System of Classification and Labelling of Chemicals: Implementation. https://en.wikipedia.org/wiki/Globally_Harmonized_System_of_Classification_and_Labelling_of_Chemicals#GHS_label_elements

7. UNECE. Transport. The United Nations Economic Commission for Europe.  http://www.unece.org/trans/areas-of-work/dangerous-goods/legal-instruments-and-recommendations/ghs/transdangerpublighsimplementation-e/legal-inst-list.html#c25883. Accessed July 20, 2018.

8. OSHA. (2012 March 26). Hazard Communication. Occupational Safety and Health Administration. https://www.osha.gov/dsg/hazcom/ Accessed August 18, 2018.

9. OSHA. Quick Fact Sheet: Hazard Communication Standard Final Rule. https://www.osha.gov/dsg/hazcom/HCSFactsheet.html. Accessed August 18, 2018.

10. OSHA. Regulations (Standard - 29 CFR). https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099. Accessed August 18, 2018.

11. Napier, Bennett. Written Interview. August 17-September 1, 2018.

12. OSHA. Establishment Search Results: Dental Laboratory.https://www.osha.gov/pls/imis/establishment.search?p_logger=1&establishment=dental+laboratory&State=all&officetype=all&Office=all&p_case=all&p_violations_exist=all&startmonth=08&startday=21&startyear=2013&endmonth=08&endday=21&endyear=2018. Accessed August 22, 2018.

13. OSHA. Industry SIC Search Results. https://urldefense.proofpoint.com/v2/url?u=https-3A__www.osha.gov_pls_imis_industry.search-3Fsic-3D-26sicgroup-3D-26naicsgroup-3D-26naics-3D339116-26state-3DAll-26officetype-3DAll-26office-3DAll-26startmonth-3D09-26startday-3D01-26startyear-3D2018-26endmonth-3D01-26endday-3D01-26endyear-3D2017-26opt-3D-26optt-3D-26scope-3D-26fedagncode-3D-26owner-3D-26emph-3D-26emphtp-3D-26p-5Fstart-3D-26p-5Ffinish-3D20-26p-5Fsort-3D-26p-5Fdesc-3DDESC-26p-5Fdirection-3DNext-26p-5Fshow-3D20&d=DwMGaQ&c=pRW6ZPn_LDv0DnDIAK65Ad0CA4hBS-2mAmNa2_oHfF0&r=H7mVH9eWQoPWg_b4zGrWqxxQACUzwCBUjsZWy6pPeZo&m=nuhRxu9i3x5a51kn4PjgfoFIiO_WZpq0y3fKofe0EYc&s=GhjuRgIoKPWfnAwIvUBN1o4qVhfQZqLI4vDUpB6jBrw&e=. Accessed September 1, 2018.

14. OSHA. OSHA Fact Sheet: OSHA Penalty Adjustments To take Effect After August 1, 2016.  https://www.osha.gov/Publications/OSHA3879.pdf. Accessed August 22, 2018 

15. OSHA. OSHA Penalties. https://www.osha.gov/penalties/. Accessed August 22, 2018

16. OSHA. OTI Education Centers: Program Statisticshttps://www.osha.gov/dte/edcenters/program_statistics.html. Accessed August 19, 2018.

17. NADL. Welcome to the National Association of Dental Laboratories. https://nadl.org/home-page.cfm. Accessed August 18, 2018.

18. NBC. Certified Dental Laboratory Handbook & Application.   https://nbccert.org/pdfs/CDLApplication.pdf. Accessed August 18, 2018.

19. NBC. CDL Application Process. https://nbccert.org/certificants/certified-dental-laboratory/cdl-application.cfm. Accessed August 18, 2018.

20. NBC. NBC Certified Dental Laboratories Who's Whohttps://nbccert.org/directories/nbc-whos-who-cdl/. Accessed August 18, 2018.

Fig 1. The OSHA Quick Card: Hazard Communication Standard Labels can be found at www.osha.gov/
Publications/OSHA3492QuickCardLabel.pdf.

Figure 1

Fig 2. The OSHA Quick Card: Hazard
Communication Standard Pictogram can
be found at www.osha.gov/Publications/
OSHA3491QuickCardPictogram.pdf.

Figure 2

Fig 3. The OSHA Quick Card: Hazard Communication Safety Data Sheet can be found at www.osha.gov/
Publications/OSHA3493QuickCardSafetyDataSheet.pdf.

Figure 3

Fig 4. The OSHA Fact Sheet: OSHA Penalty
Adjustments can be found at www.osha.gov/
Publications/OSHA3879.pdf.

Figure 4

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PROVIDER: AEGIS Publications, LLC
SOURCE: Inside Dental Technology | December 2018

Learning Objectives:

  • Grasp the historical transformations related to product labeling systems
  • Identify and relate the Globally Harmonized System (GHS) introduced by the United Nations and the Hazard
  • Communication Standard (HCS) introduced by OSHA in the United States
  • Appreciate the importance of product labeling in the dental laboratory profession
  • Relate the HCS Standard to the dental laboratory profession

Disclosures:

The author reports no conflicts of interest associated with this work.