Thursday, September 30, 2010

The New Administration is Walking the Walk When it Comes to OSHA

A good read this week for those interested in OSHA enforcement is “There’s a New Sheriff in Town – President Obama’s Enforcement-Driven OSHA”, written by Edwin G. Foulke. It is interesting because, written a little over a year ago, it gives us a chance to review whether or not OSHA really is stepping up its game, and not just giving lip service to the concerned parties.

The article makes the argument that the Obama Administration is getting serious about OSHA; that enforcement would increase and new standards would be put into place. In regards to the latter, we talked on this blog just a couple of weeks ago about OSHA’s solicitation for suggestions of which chemicals to create or update permissible exposure limits for. This action is certainly a positive sign for employee safety in occupations that involve the risk of exposure to dangerous chemicals – such as toxic sterilant gases in the healthcare industry. As far as enforcement is concerned, OSHA received more funding focused on enforcement, hired more inspectors, and has increased the number of overall inspections. In addition, OSHA opened up four new regional offices earlier this month in Las Vegas, Phoenix, San Diego, and Oakland, CA.

As we’ve discussed on this blog before, OSHA enforcement is vital, especially in the healthcare industry. Our post dated July 21, 2010 entitled “Should OSHA Update Regulation of Chemical Sterilants?” cited a study that found decreased enforcement can lead to a decrease in measurement and monitoring by employers as well as an increased probability of exceeding the permissible exposure limit for Ethylene Oxide. The simple explanation here is that if OSHA is lax on enforcement, employers in turn lighten up their actions to keep employees safe, which leads to an increased probability that their workers will be exposed to harmful chemicals.

Only time will tell if this recent surge in OSHA enforcement will last. Regardless, it is encouraging to see the federal government taking employee safety more seriously across all industries. However, primary responsibility for employee safety will always fall on the employers themselves. Hopefully this recent step-up in enforcement by OSHA will remind all of us to put safety as a top priority and act accordingly.

Foulke’s article can be found here: http://www.martindale.com/legal-library/Article_Abstract.aspx?an=occupational-safety-health-law&id=747318

Wednesday, September 22, 2010

Times of Change for Healthcare Providers Must Not Distract Focus from Employee Safety

As many of you know, the FDA issued a recall of the Steris System 1 sterilizer late last year because changes to the system over the years were not evaluated and approved by the FDA. Thus the FDA was unable to validate the effectiveness and safety of using that particular system. Because of this recall, hospitals have been transitioning to new sterilizer systems such as Steris Corporation’s System 1E and Advanced Sterilization Products’ Sterrad line of peracetic acid and hydrogen peroxide based sterilizers, respectively.

When switching from one sterilization system to another, hospitals often focus on sterilization efficacy and materials compatibility, but it is important to remember that all sterilants are used to kill microbial life, making them harmful to humans if exposure should occur. Therefore, whatever sterilizer is used, both employers and employees should be aware of potential exposure issues to liquid or gaseous chemical sterilants. Where gas exposure is a risk factor, continuous monitoring may be needed – especially where the odor threshold of the sterilant used is near or greater than the OSHA PEL or other recognized exposure limit such as the EPA’s AEGLs.

This is not a knock against the safety claims of sterilizer producers, but only to say that accidents can and do happen, due to equipment malfunction or wear and tear, as well as human error. Monitoring systems are not intended for when sterilizers are working properly, but to protect health care workers when an accident occurs.

In summary, as a healthcare facility is reviewing its sterilization system or process, it is very important to include questions about employee safety, including whether continuous monitoring of the workplace for sterilant gases and vapors is necessary.

Tuesday, September 14, 2010

OSHA Recognizes its Shortfalls

Recently, OSHA opened up their virtual doors and allowed experts across the US to express their concerns about the shortcomings of the organization’s current permissible exposure limits (PELs). For two weeks at the end of last month, the OSHA website provided a forum for people to “help the Agency identify the chemicals of concern on which (OSHA) can focus (their) initial efforts…” The website called for the nomination of chemicals that have a “particularly inadequate” PEL or none at all, and that “are putting workers at risk for occupational illness.” The nominating website is still up at http://www.osha.gov/pelforum.html, but it is unclear if OSHA will accept late entries.

What is so interesting about this step by OSHA is the fact that the agency explicitly recognizes that their standards are not adequate in some cases. As the website states:

“Unfortunately, most of OSHA's PELs that were adopted when the Agency was first created have remained unchanged. Meanwhile, science has moved forward and health data indicate hazards below the levels permitted by many OSHA PELs. Like the occupational health community at large, OSHA realizes the inadequacy of many of its PELs and is seeking creative solutions, both long term and short term, to address this inadequacy.”

This statement from OSHA clearly refutes the common misconception of many employers who think that if there is not a PEL for a given chemical there is no need to monitor it or take other precautions because OSHA does not think it is a threat to worker safety. It is perfectly clear now more than ever that simply because OSHA does not have standards for certain chemicals does not mean that they are safe. With the help of chemical experts across the country, OSHA standards are beginning to catch up to modern technology and data, and workplaces are becoming safer than ever.

ChemDAQ’s own Dr. Richard Warburton submitted recommendations for Peracetic Acid, Glutaraldehyde, and Ortho-phthalaldehyde on the site.

While we are certainly aware that these processes take time, it is encouraging to see OSHA take the initiative in leading the way for updated PELs to keep workers safe.

Tuesday, September 7, 2010

Should OSHA Develop a PEL for Peracetic Acid?

As we have discussed on this blog before, peracetic acid, also known as peroxyacetic acid (PAA), can be quite hazardous if workers are exposed to even a small concentration of the gas. Research has confirmed that PAA is a primary irritant and a known tumorigen, as well as a possible animal carcinogen. Exposure to the gas can be severely irritating to the eyes, nose, throat, and lungs as well as cause circulatory collapse. For these reasons and more, we feel strongly that OSHA should develop a permissible exposure limit (PEL) for PAA.

The current PEL for hydrogen peroxide (H2O2) is 1ppm, due to its classification as an oxidizer. However, PAA is a stronger oxidizer than H2O2 and the effects of exposure to H2O2 are mitigated by the action of the catalase enzyme in the body, which helps to decompose the compound into hydrogen and water. In light of this, the PEL for PAA should certainly be lower than that of H2O2, hence, less than 1ppm.

The Environmental Protection Agency sets Acute Exposure Level Guidelines (AEGL’s) for hazardous gases like PAA. The first AEGL is similar to an 8 hour PEL that OSHA uses in that it represents the “airborne concentration…of a substance above which it is predicted that the general population, including susceptible individuals, could experience notable discomfort, irritation, or certain asymptomatic nonsensory effects.” For PAA, the EPA sets the 8hr AEGL 1 at 0.17ppm. Furthermore, a 2001 study published by the British Occupational Hygiene Society recommended a Threshold Limit Value (TLV) of 0.2ppm, based on effects researchers observed in mice after exposure to PAA. Lastly, Solvay, a large manufacturer of PAA, recommends a time weighted average of 0.15ppm as the exposure limit.

In light of this evidence, it seems fitting to establish an OSHA PEL for PAA somewhere between 0.1 and 0.2 ppm. This would help to increase worker awareness and safety in facilities that utilize high concentrations of this potentially hazardous gas.