June 2012

International Regulatory Influences

International Regulatory Influences

GHS finally arrives in the U.S: Part 1

On March 19, the moment we have been patiently waiting for arrived: The U.S. Occupational Safety & Health Administration (OSHA) released the final version of their Globally Harmonized System (GHS) regulation. The rule, which OSHA is informally calling Hazcom 2012, replaces the previous Hazard Communications Standard (HCS) and radically alters hazard communication in the U.S. A new 16-section format of Material Safety Data Sheets, now simply called Safety Data Sheets (SDSs), is the required standard in the U.S. Workplace industrial labels are radically altered as well, though the  regulations do not apply to consumer products. Workers will need to be trained in a new complex system of hazard groups, classes and categories. Required hazard statements will appear on SDSs and labels, along with nine pictograms, each contained within a red diamond.

The change will be a costly one for industry, as workers will need to be trained in the new standard and labels and SDSs will need to be created. For instance, OSHA estimates the cost of labor and software to author new SDSs to be $406 per SDS for large businesses (500+ employees) to $462 per SDS for small businesses (fewer than 99 employees). Companies will need to ensure they set aside sufficient resources to comply with the new regulations.

Hazcom 2012 Timeline

We are fortunate that OSHA extended the timeline for GHS compliance from the draft regulations. The important dates are as follows:

• Dec.1, 2013: All employees must be trained on SDS and labels.
• June 1, 2015: Compliance with the final rule for SDSs and workplace labels. This is the same date as EU’s deadline date for mixtures.
• Dec. 1, 2015: Distributors must stop shipping products with “old” labels.

Note that unlike the EU, there is no staggered phase in date for (pure) substances and mixtures of more than one GHS finally arrives in the U.S: Part 1 substance. This presents a bit of a problem, as you need the classifications for the individual substances in order to properly classify the mixture. There is no official or mandatory U.S. inventory of classifications, but OSHA believes the vast majority of substances have already been classified for GHS in Europe, Japan and Korea.

Differences Between GHS and Hazcom 2012

Although GHS is The Globally Harmonized System, it is neither truly global nor truly harmonized. There are substantial differences between the OSHA implementation, the EU implementation and the UN’s Purple Book.

Much of GHS falls outside of OSHA’s bailiwick, such as the environmental provisions; the entire GHS environmental hazard group is left out of Hazcom 2012. Furthermore, Hazcom 2012 does not require any information that would normally appear on Sections 12–15 of a GHS SDS, however these section headings still need to appear on the document.

Unlike most other jurisdictions, such as the EU, trade secret provisions in Hazcom 2012 allow companies to keep chemical names and concentrations as “proprietary” without needing to register those proprietary claims with the government. There are a number of significant additions to Hazcom 2012, including that the American Conference of Industrial Hygienists (ACGIH) Threshold Limit Values will need to be referenced on Hazcom 2012 SDSs, as they are under the existing HCS.

OSHA has added four classes to Hazcom 2012, which do not appear in other implementations of GHS:
• Combustible Dust
• Simple Asphyxiants
• Pyrophoric Gases
• “Hazards Not Otherwise Classified”

The last classification is particularly problematic, as SDS and label authors are required to list hazards that do not have Hazcom 2012 classifications on labels and SDSs. It is not clear what these hazards will be (OSHA gives the example of static accumulators). It will now be necessary to not only classify hazards that are listed in the regulations, it will be necessary to see which supplemental classifications become “industry standard” and ensure those are being classified as well.

Having a single SDS that will cover both the U.S. plus the EU will be possible, but difficult. An author will need to ensure that the SDS is compliant with the EU’s 453/2010 format. The document will need to cover information that is unique to each jurisdiction, such as California Prop 65 and the German Water Regulations. It will be necessary to include the environmental classes that are in the EU and the four U.S. classes not found in the EU. Finally, a joint document will not be able to take advantage of the U.S. trade secret provisions unless they obtain permission from the EU to claim trade secret status.

Hazcom 2012 –Industry Seeing Red

Under Hazcom 2012, it is mandatory that the red diamond border around pictograms be printed in red. Having red diamonds pre-printed onto labels will likely be difficult, as different labels will have different numbers of pictograms and it is not permitted under the regulations to have blank diamonds or to fill in the diamonds with information such as “THIS DIAMOND INTENTIONALLY LEFT BLANK.” As such, we expect many companies will need to upgrade their equipment in order to print in both red and black.

Hazcom 2012 – Stay Tuned, Stay Up-To-Date

There are still a number of unanswered questions with Hazcom 2012, particularly around creating single documents that are compliant in both the EU and the U.S. We expect that OSHA will issue a number of clarifications and guidance documents in the next two years. The U.S. Department of Labor has created a portal where the newest information on GHS is posted; it is available at: http://www.osha.gov/dsg/hazcom/index.html

In the next article, we will get “into the weeds” and examine some of the specifics of the regulations as they pertain to the aerosol industry.