Wednesday, March 28, 2012

OSHA Globally Harmonizes Hazard Communication Standard

On March 26th, OSHA published its final rules for amending the Hazard Communication standard (HCS) 29 CFR 1910.1200 to implement the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in the Federal Register, 3/26/12.

This new standard is intended to simplify hazard communication requirements. Within the US several federal agencies regulate the use and transportation of chemicals and each agency has its own hazard communication requirements, resulting in chemical producing or importing companies having to prepare duplicates sets of documents etc. to meet the various requirements. Companies doing business abroad have a greater problem since each country has its own hazard communication requirements. The principle idea behind the GHS changes is to provide a common framework for categorizing risks from chemicals and methods of labeling, and safety data sheets. Therefore the same labels or safety data sheets should meet the requirements around the world.

The new HCS will include classification of chemicals by hazard, new labeling requirements, employee training and safety data sheets.

Categorization of Chemicals
Under the GHS, each hazard (e.g., Explosives, Carcinogenicity) is considered to be a hazard class and the classes are generally sub-divided based on the degree of the hazard. For example, Carcinogenicity has two hazard categories. Category one is for known or presumed human carcinogens while category two encompasses suspected human carcinogens.

The hazard communication requirements under the GHS are directly based on the hazard classification. For each class and category of hazard, a harmonized signal word (e.g., Danger), pictogram (e.g., skull and crossbones), and hazard statement (e.g., Fatal if Swallowed) must be used. Thus, once a chemical is classified, the GHS provides the specific core information to convey to users of that chemical.

In addition to precautionary statements, labels will include up to eight different pictograms. Each of these pictograms consists of a different symbol in black on a white background within a red square frame set on a point (i.e., a red diamond). The specific pictograms to be used on a label are determined based on the hazard classification of the substance in question.

Safety Data Sheets
The GHS adopted the ANSI Z400.1 sixteen section format for the safety data sheet (SDS) (no longer called material safety data sheet). While many chemical suppliers already use this format, they are not currently required to. Chemical manufacturers and importers will have to re-evaluate chemicals to ensure they are classified appropriately. Chemicals will have to be assigned to the appropriate health hazard category as described above, and for their physical hazards. The criteria for physical hazards are generally consistent with current DOT requirements for transport.

The training requirements under the new standard are similar to the old other than to include the new GHS elements.

State Plans
Those States which have adopted their own plans in partnership with OSHA will have to update their plans within six months of publication of the final rule. Each State's existing requirements will continue to be in effect until it adopts the required revisions.

This rule becomes effective on May 25, 2012 and all employers will have to complete training of their employees by December 1, 2013. The new format labels and safety data sheets must be in place by June 1, 2015, however, distributors will have an additional six months (by December 1, 2015). In the interim employers will be considered to be in compliance as long as they are complying with either the existing Hazard Communication Standard or the new one.

This blog is a very short summary of the new hazard communication standard. For those people who want more information, OSHA has created a web page with more information, the Federal Register page mentioned above goes into great detail about the development of this new regulation; and OSHA has prepared a side by side comparison of the current HCS with the new one.

Wednesday, March 14, 2012

Comparison between OSHA PELs and EH40 Occupational Exposure Limits

Here in the US we are used to thinking about OSHA and permissible exposure limits (PELs), but every industrialized country has their own occupational exposure limits. Many countries or provinces either base their exposure limits on the ACGIH TLVs or reference them exactly.

The European Union has developed its own set of occupational exposure levels which are implemented in each EU country. The UK workplace exposure levels (WELs) are summarized in a document called EH40. The EH40 document is regularly updated and the last version was published in 2011 and is available from the UK’s Health and Safety Executive (analogous to OSHA) for £15 paper copy or free download. The EH40 also has a lot of useful information, such as how exposure limits are calculated etc.

It is interesting to make a comparison between the EH40 exposure values and the OSHA PELs in 29 CFR 1910.1000 and other OSHA standards for a few select compounds relevant to disinfection and sterilization in food and healthcare. In general the exposure limits are similar, which is to be expected since published research reports relevant to the effect of chemical occupational exposure is available world wide and neither standard is developed in a regulatory vacuum.

Ethylene oxide:
OSHA 1 ppm 8hr TWA, 5 ppm 15 min TWA
EH40 5 ppm 8 Hr TWA

OSHA 0.75 ppm 8 Hr TWA, 2 ppm 15 min TWA
EH40 2 ppm 8 Hr TWA, 2 PPM 15 min TWA

OSHA n/a
EH40 0.05 ppm 8 Hr TWA, 0.05 ppm 15 min TWA

Hydrogen Peroxide:
OSHA 1 ppm 8 Hr TWA
EH40 1 ppm 8 Hr TWA, 2 ppm 15 min TWA

OSHA 0.1 ppm 8 hr TWA
EH40 0.2 ppm 15 min TWA

This limited comparison shows that the OSHA standard is more stringent for ethylene oxide and formaldehyde (both fairly recent standards). Glutaraldehyde is not listed by OSHA, though OSHA recognizes the harmful effects of glutaraldehyde and provides guidance for its safe use. Unlike the EH40 values which are periodically updated, the OSHA PEL s are still largely the same as they were when first promulgated in 1972. OSHA is aware of the senior status of its PELs and is planning to update them.

One notable difference of note is the short term exposure limit (STEL) for hydrogen peroxide in the EH40. Hydrogen peroxide is widely used in healthcare and food processing for sterilization and disinfection and the STEL emphasizes the importance of avoiding even short term exposure to low ppm concentrations of hydrogen peroxide vapor.

While the EH40 WELs have no legal standing in the US, they can be used to provide an industry standard for what constitutes an safe level, in similar manner to other industry standards such as the ACGIH’s threshold limit values (TLVs); and are particularly useful for those compounds for which there are no OSHA PELs or for which the OSHA PELs are particularly obsolete.

However, several new compounds finding use in healthcare and the food industry such as peracetic acid and o-phthalaldehyde are listed in neither the OSHA PELs nor the EH40. While the EH40 is updated more regularly than the OSHA PELs, as with any government action, the regulatory wheels move slowly. Users should therefore consult other reliable sources to find appropriate safety information. The ACGIH had led the development of occupational exposure standards for over five decades and continues to lead today for example with its proposed STEL for PAA of 0.2 ppm (15 min TWA).

Wednesday, March 7, 2012

OSHA’s Regulatory Agenda

Towards the end of 2011, OSHA published its regulatory agenda for the upcoming year. Two items are especially relevant to gas detection in healthcare, food processing and other industries: The revision of the HazCom standard and the revision of the OSHA Permissible exposure limits (PELs).

The Hazard Communication standard applies to all companies using chemicals and requires appropriate material safety data sheets (MSDSs), labels, employee training etc. One problem facing the HazCom Standard is that different government agencies apply different standards and across the world the standards differ significantly from country to country, meaning that different labels and MSDSs are needed from one location to the next. The United Nations has developed a global harmonization standard (GHS) that can be used to classify chemicals according to their properties. OSHA is working towards updating the HazCom standard to be compliant with the GHS.

Most of the current OSHA PELs were adopted under the 1970 Occupational Safety and Health Act (OSH Act) from the 1968 ACGIH TLV values, since they were already federally recognized consensus standards. With a few exceptions, the majority of the PELs today are unchanged since they were first adopted even though a considerable amount of chemical safety data has been collected since then and the ACGIH TLVs have been regularly updated. In 1989 OSHA attempted a broad updating of the PELs, introducing 164 new PELs and lowering 212 existing ones. However, these changes were subsequently overturned by the Eleventh Circuit Court of Appeals in 1992, on the grounds that OSHA failed to show the health benefits versus the cost of implementation for each individual compound, as required under the OSH Act. The PELs thus reverted back to their prior values. OSHA is again looking at revising the PELs, but the legal framework remains to be seen.

The ChemDAQ blog will be following both of these themes over time and will provide updates as more information becomes available.