Wednesday, December 15, 2010

NIOSH Announces Upcoming Survey for IAHCSMM Members

At the end of next month, the National Institute for Occupational Safety and Health (NIOSH) will launch their online Health and Safety Practices Survey of Healthcare Workers. The survey will collect data from a random sample of International Association of Healthcare Central Service Materiel Management (IAHCSMM) members concerning “health and safety practices and types of exposure controls used by healthcare workers who handle or come in contact with hazardous chemical agents,” specifically aerosolized medications, antineoplastic agents, chemical sterilants, high level disinfectants, surgical smoke, and anesthetic gases. NIOSH plans to release a report to all IAHCSMM members detailing aggregate data from all survey respondents.

We join NIOSH in encouraging all IAHCSMM members who are asked to complete the survey to do so, as the data provided will be invaluable in determining the best practices to keep employees safe from exposure to chemical agents in the workplace. The more data that is shared, the more educated in chemical safety employers and employees alike will become. As we’ve discussed on this blog before, education is the single most important component of employee safety. Surveys like this one play a key role in increasing awareness of the potential dangers of chemical agents, as well as the best ways to prevent exposure.

For more information on NIOSH and the work they are doing to keep healthcare workers safe, visit:

Monday, December 6, 2010

How will the Results of the Midterm Elections affect Workplace Safety?

There has been a lot of talk over the last several weeks concerning how the Republican takeover of Congress will affect OSHA’s activity over the next 2 years. Worker safety is, should, and always will be a nonpartisan issue. However, how many tax-payer dollars are given to organizations that enforce regulations of the workplace is a partisan issue, for better or worse. Since the Obama Administration began, funding for OSHA enforcement has increased, as has the number of inspectors and overall inspections. Many fear that with the continuing economic struggles of the country, a Republican Congress will not continue the pattern of increasing OSHA’s budget as the Democrats have. Even if that is the case, it shouldn’t be anything to worry about in terms of worker safety.

Workplace safety is a matter of law, but as we have pointed out in the past, it is also a matter of employer responsibility. If an accident were to occur at a facility, the blame always falls on the employer, not OSHA, as the responsible party. The reason for this can be understood quite simply by reviewing the General Duty Clause in the Occupational Safety and Health Act of 1970. It states, “Each employer shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.” Thus, whether OSHA reduces the number of inspections they conduct or not, the employer still has a duty to ensure the safety of their workers. Decreased OSHA activity is not an excuse for decreased worker safety.

Recently, OSHA published the results of its informal survey on what chemicals should be regulated. The optional survey received a great response from employers and experts about chemicals that are not currently regulated, but should be because of their harmful effects to humans when exposed. Seeing as new information is constantly being revealed, employers have a duty to protect their workers from new threats, whether OSHA establishes a permissible exposure limit or not. Thus, education of employers about such chemicals is a key issue as well. As a government bureaucracy, OSHA moves slowly, and cannot possibly set a regulation for everything that could be potentially harmful in the workplace. Some element of responsibility needs to fall on the individual employers themselves.

The bottom line is that just because OSHA does not say an employer has to structure the workplace a certain way, establish rules to prevent employee injuries, or monitor a chemical they use, does not mean it isn’t the right thing to do, and even the lawful thing to do under the General Duty Clause. If an employer has evidence that something may cause harm to their employees, they should take the appropriate steps to prevent it.

Employee safety has nothing to do with who controls Congress.

Thursday, November 4, 2010

EPA Solicits Requests for Chemical Substance Nominations

Recently, the Environmental Protection Agency (EPA) published a notice on the Federal Register calling for public “nominations for substances to be considered for an assessment or reassessment in its IRIS Program”, similar to the request made by OSHA a couple of months ago (see: The EPA’s IRIS (Integrated Risk Information System, Program collects data and evaluates risk information on effects that may result from exposure to environmental contaminants. The database itself contains searchable documents describing the health effects of exposure to more than 540 different chemical substances for which the EPA issues exposure level recommendations.

According to the EPA, nominations are evaluated on 5 factors:

(1) Potential public health impact
(2) EPA statutory, regulatory, or program-specific implementation needs
(3) Availability of new scientific information or methodology that might significantly change the current IRIS information
(4) Interest to other governmental agencies or the public
(5) Availability of other scientific assessment documents that could serve as a basis for an IRIS assessment

We are encouraging readers to submit nominations for Peracetic Acid (PAA) as well as Ortho-phthalaldehyde (OPA), which are both used in the sterilization and disinfection of medical instruments, and whose potential adverse health effects have been well-documented.

Nominations are being accepted via email ( as well as online ( , enter Docket ID No. EPA-HQ-ORD-2010-0744, and select “submit a comment”).

The notice on the Federal Register and complete instructions can be found here:

Friday, October 15, 2010

What is the difference between a REL and a PEL?

There is often confusion between exposure limits put out by different agencies even within the same administration. For example, the National Institute for Occupational Safety and Health (NIOSH) establishes Recommended Exposure Limits (RELs) whereas the Occupational Safety and Health Administration (OSHA) issues Permissible Exposure Limits (PELs). Realizing the difference between the two is as easy as looking at the names themselves: What is “recommended” vs. what is “permissible”.

NIOSH RELs are supposed to be based on the best available science (using human or animal health effects data). According to the CDC’s website, “To the extent feasible, NIOSH will project not only a no-effect exposure, but also exposure levels at which there may be residual risks. This policy applies to all workplace hazards, including carcinogens, and is responsive to Section 20(a)(3) of the Occupational Safety and Health Act of 1970, which charges NIOSH to ‘. . .describe exposure levels that are safe for various periods of employment, including but not limited to the exposure levels at which no employee will suffer impaired health or functional capacities or diminished life expectancy as a result of his work experience.’”

OSHA PELs, on the other hand, are subject to the rulemaking and political process, meaning that the interests of all parties involved are taken into consideration. Thus, OSHA does not have the luxury of relying strictly on science. Establishing PELs sometimes even come down to court rulings.

Take, for example, the extremely popular disinfectant and preservative Formaldehyde, a known human carcinogen according to the International Agency for Research on Cancer (IARC). The OSHA PEL is set at 0.75ppm as an 8 hour time-weighted average. In contrast, the NIOSH REL is a 0.016ppm 8 hour time-weighted average with a ceiling set at 0.1ppm. This difference reflects the disconnect between what the political process deems appropriate for exposure and what hard science says is harmful.

What is the takeaway here? To be frank, the OSHA PEL is not the safe limit below which harm cannot occur. Rather it is the legal limit (i.e. what is “permissible”), below which serious harm should not occur to most people. Thus, while the OSHA PEL represents the legal exposure limit, it does not necessarily represent the desired exposure level. To that extent, the NIOSH REL is the more appropriate number.

Everyday we do activities that carry risk of injury including workplace practices. Formaldehyde use offers many benefits, but the employer must reduce the risk of employee exposure to below the OSHA PEL and should reduce the risk to below the NIOSH REL.

Employers can reduce the risk of formaldehyde exposure through implementation of sufficient engineering controls, monitoring devices, personal protective equipment, worker training, good work practices, regular equipment maintenance etc. For those compounds which are potentially hazardous at levels below that of reliable human perception, continuous gas monitors should be used. Where possible, employers should strive to meet the NIOSH RELS, rather than the OSHA PELs.

Wednesday, October 6, 2010

New Book on AEGLs Published by the National Academies Press

The National Academies Press published a book recently discussing the Environmental Protection Agency’s (EPA’s) Acute Exposure Guideline Levels (AEGLs) for Selected Airborne Chemicals. The book provides comprehensive summaries of studies and experiments that the EPA used when determining exposure limits for certain chemicals.

One chemical discussed in the book is Peracetic Acid (PAA), which we have discussed in detail on this blog before. PAA has been receiving increased attention in recent years, as its use as a disinfectant against bacteria, fungi, and viruses is becoming more widespread in both the healthcare and food industries. PAA can be quite harmful in the event of exposure as it is corrosive and irritating to the eyes, mucous membranes of the respiratory tract, and skin. As the chapter states, “extreme discomfort and irritation” can occur in humans after exposure to just 5ppm for 3 minutes. Lethal concentrations of PAA can cause hemorrhage, edema, and consolidation of the lungs of those exposed.

The EPA typically sets 3 different AEGL values for chemicals. In general, the first level refers to the concentration of a chemical which would cause discomfort, the second long lasting adverse health effects, and the third life-threatening health effects. AEGL 1 for PAA is set at 0.17ppm, which is considered to be the threshold for irritation to mucous membranes and eyes. AEGL 2 is set at 0.5ppm, the concentration at which “slight to tolerable discomfort to nasal membranes and eyes” begins to occur. AEGL 3 is set at 4.1mg/m3 (which is not converted to ppm because values are based on exposure to aerosol). While the data for AEGL 3 was based on studies in animals (rats and mice), there is evidence that humans may be slightly more sensitive to PAA.

As we have pointed out before, there is currently no OSHA Permissible Exposure Limit (PEL) for PAA. With the recent actions taken by the administration, there is reason to believe that a new round of PELs may be issued in the near future. However, it is important to remember that OSHA PELs are not an all inclusive list of chemicals that could be harmful to humans if exposed. Data reported by the EPA in articles and books like this serve as practical reminders that chemicals used to protect us can also hurt us if we don’t protect ourselves from potential exposure.

A link to a free PDF download of the new book about AEGLs can be found here:

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:

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, 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.

Monday, August 30, 2010

CDC Releases New Study on Chemical Exposure

Recently, the Centers for Disease Control and Prevention (CDC) updated information on the levels of 51 chemicals reported in the Fourth Report on Human Exposure to Environmental Chemicals, which was originally released in December of last year. This study examined human exposure to many common chemicals which present potential health risks.

Potentially hazardous chemicals that were found in a large majority of subjects included Polybrominated Diphenyl Ethers, found in many manufactured products, Bisphenol A, often found in plastic food containers such as PC and PVC based water bottles, and Perfluorooctanoic Acid, which is found in the polymer used to produce heat-resistant, non-stick coatings in cookware. On the bright side, the study also found that levels of Lead in children’s blood were declining, as is exposure to environmental tobacco smoke. Levels of the toxic elements Arsenic, Mercury, Cadmium, as well as volatile organic compounds were also explored in the report.

The CDC points out that the report provides “unique exposure information to scientists, physicians, and health officials to help prevent effects that may result from exposure to environmental chemicals.” They plan to use the study to learn more about which chemicals get into Americans’ bodies and at what concentrations, establish reference values in order to determine if an individual or group has an unusually high exposure, and track exposure levels over time.

Little information is currently available about the effects of exposure to environmental concentrations of many of chemicals in everyday use. Studies like this one are essential for providing the information necessary to make good policy decisions.

A summary of the report is available at:

Wednesday, August 18, 2010

Where did the OSHA PEL for H2O2 Come From?

As most of you know, OSHA establishes Permissible Exposure Limits (PELs) in order to protect workers who have the possibility of being exposed to harmful chemicals. PELs are usually expressed as ceiling limits or time-weighted averages for the short-term and long-term – 15 minutes and 8 hours respectively. While knowing these limits are important for anyone that could potentially come in contact with the chemicals, it is also both interesting and helpful to understand where the numbers themselves came from.

In 1954, three scientists performed a series of experiments at the Army Chemical Center in Maryland intended to shed more light on the toxicity of hydrogen peroxide (H2O2) vapor. The study, “Inhalation Toxicity of Ninety Per Cent Hydrogen Peroxide Vapor: Acute, Sub acute, and Chronic Exposures of Laboratory Animals”, involved exposing animals to various levels of H2O2 and observing the health effects. The paper they produced is considered classic research on H2O2 exposure and was the basis for the American Conference of Government and Industrial Hygienists’ (ACGIH’s) threshold limit value (TLV) of 1 ppm for H2O2. OSHA was created in 1970 and it adopted the ACGIH TLV’s as the OSHA PELs a couple of years later.

In the first experiment, rats were exposed to a very high (2880 ppm) concentration of H2O2 for 8 hours. While none of the rats died, they all showed severe congestion of lungs and trachea immediately following exposure. Within 3 days, pulmonary edema occurred and within 14 days, the majority of lungs showed many areas of alveolar emphysema as well as severe congestion. What the scientists learned was that while there was initially minor irritation, more severe symptoms developed later. There were similar results when the concentration of H2O2 was reduced to 243 – 308ppm for 8 hours.

In the second experiment, rats and mice were exposed to about 67ppm of H2O2 vapor for 6 hours a day, 5 days a week, for 6 weeks. Results included profuse nasal discharge after 2 weeks of exposure, hair loss around the nose in the 5th week (most likely due to animals scratching to relieve irritation), high rates of death among mice (80% after 18 exposures), and some congestion in the lungs.

The third experiment, however, was perhaps the most telling. In this series, dogs were exposed to 7ppm of H2O2 for six hours a day, five days a week, for 6 months. It was found that while there were no toxicity signs for the first 23 weeks, long-term exposure caused baldness, hair bleaching, and permanent lung damage, as well as general irritation such as sneezing and lacrimation.

Because of these results, the scientists concluded that long term exposure to even low concentrations of ~7ppm or more will produce impermanent lung damage in animals. Furthermore, one of the most important results from the study is that health effects resulting from exposure often do not appear immediately, and often present themselves days, or weeks later. From an occupational health perspective it should be noted that hydrogen peroxide has almost no odor and so is imperceptible until well above the OSHA PEL of 1 ppm. Therefore, continuous monitoring of the workplace to prevent exposures before they occur is recommended for all facilities using high concentrations of H2O2 where there is the potential for employee exposure.

Thursday, August 12, 2010

Should OSHA’s Standard for Ethylene Oxide be Revised?

We touched on this topic a couple of weeks ago when discussing generally if OSHA should consider updating its regulations of chemical sterilants. We came to the conclusion that it should, as there has been a large amount of new data on many chemicals commonly used in sterilization and disinfection, but that enforcement would be a key issue as well. This week, we’ll take a closer look at OSHA’s standard for Ethylene Oxide (1910.1047), which exists to protect those who may potentially be exposed to the sterilant gas. Specifically, we will focus on section d of that standard – “Exposure Monitoring”.

While the ultimate goal of the standard is to promote worker safety, section d serves to create a false sense of security for those using EtO at their facility. This section requires employers to take initial measurements and then, if the standards are met at that time, states that it is not necessary to measure again for as long as 6 months in some cases. Going against all logic, this section seems to claim that if there is not a problem now, there will not be one in the future. As we all know too well, equipment can fail, and accidents can and do occur.

What is the solution to this problem? Enforcing a simple Permissible Exposure Limit (PEL) would require employers to ensure that there is a safe work environment. Continuous monitoring of the workplace would ensure that employees are safe at ALL times, instead of just the times samples are taken as currently required in the standard. The bottom line is that accidents are always somewhat unexpected events. Telling employers that they “may rely on such earlier monitoring results to satisfy the requirements” greatly increases the likelihood that accidental leaks will not be detected.

When 1910.1047 was drafted in the early 1980s, continuous monitors were not readily available, which is certainly not the case today. Revising the EtO standard to match current technology is something that must happen if the goal of the document is to promote worker safety above all else.

1910.1047 can be found here:

Monday, August 2, 2010

Why do people think Hydrogen Peroxide is less hazardous than Ethylene Oxide?

When you look at the EtO standard, 1910.1047, the first thing that comes to mind is that it is an enormous amount of information. The standard is very long and detailed concerning the use, storage, and monitoring of EtO. When you then research the H2O2 standard, it appears to be a simple one liner in 1910.1000. It would follow from this observation that H202 is much less hazardous than EtO because OSHA did not dedicate an entire standard to it as they did with EtO.

However, what you may not realize is that H2O2 is covered by more than just 1910.1000. It is also covered by the hazard communication standard (1910.1200), the emergency action plan standard (1910.38) and other standards. If you combine all these other standards, then the EtO standard does not look so much larger. It is important to remember that in the 1980s, EtO became recognized as a probable and later as a known human carcinogen, so OSHA developed individual standards for several known human carcinogens including EtO. H2O2 is generally not considered to be carcinogenic, although ACGIH says it is an animal carcinogen, and so hydrogen peroxide is covered under 1910.1000, where EtO used to be.

For comparison, OSHA’s 8 hour Permissible Exposure Limit (PEL) for both EtO AND H2O2 is 1ppm. However, NIOSH’s Immediately Dangerous to Life and Health Level is only 75ppm for H2O2, but 800ppm for EtO. While H2O2 is not a known human carcinogen, it can still inflict serious harm on those who are exposed such as permanent lung damage and neurological deficits.

To peruse the relevant standards, follow these links:


Wednesday, July 21, 2010

Should OSHA Update Regulations of Chemical Sterilants?

The first and most obvious reason why OSHA should update its regulations is to increase employee safety. Since the federal permissible exposure limits were first promulgated in 1971, new data has emerged about both the short and long-term effects of exposure to chemical sterilants, and this new data should be reflected in the OSHA standards. One of the reasons that many hospitals are phasing Ethylene Oxide (EtO) out of their sterile processing is that the risks associated with EtO are very well known (carcinogen, mutagen, spontaneous abortions, etc). As EtO is phased out, alternatives like hydrogen peroxide, ozone, and peracetic acid are often thought to cause fewer health risks in part because the regulations concerning them are less specific than those that regulate the use of EtO. However, these chemicals can be just as, if not more, dangerous than EtO.

With the exception of a few standards for carcinogenic compounds like EtO, the OSHA PELs of today are largely unchanged from when they were first adopted from the ACGIH TLV values back in 1972. The OSHA PELs should be updated to reflect the new chemical hygiene information of almost four decades and new chemicals used in the work place. If OSHA were to update their regulations reflecting that fact, hospitals would likely be more educated and responsible with their use as the transition to such alternatives continues.

Consistent OSHA enforcement of their regulations is equally important for ensuring workplace safety. A study conducted in 2004 that was published in the American Journal of Public Health followed long-term EtO exposure trends in US hospitals and its relationship with OSHA regulatory and enforcement actions. The study found that exposures declined steadily for the first several years after OSHA set new standards and measurement and monitoring increased. Between 1996 and 2004, however, the probability of exceeding the short-term exposure limit increased while measuring and monitoring decreased, coinciding with a decline in enforcement of the EtO standard. The study’s conclusion states that the data “indicates the need for renewed regulatory and other intervention efforts to protect health care workers from EtO’s carcinogenic, allergic-sensitizing, reproductive, and other hazards.” We argue that the same logic applies to other chemical sterilants in addition to EtO. Furthermore, as the study suggests, updated regulations alone would not automatically reduce the risk of worker exposure; enforcement is equally as important.

In summary, to improve workplace safety for those who use chemical sterilants in healthcare, we need to have updated regulations that reflect the current chemicals used and the current knowledge of their exposure risks and consistent enforcement of those regulations. Thus, while proper regulations and enforcement are important, what actually protects employees is having all parties concerned focusing on creating and maintaining a safe work environment, meeting the regulations, providing the engineering controls (ventilation, continuous gas monitors etc), using the personal protective equipment, and developing and using good work practices.

For more information about the American Journal of Public Health study, visit:

Wednesday, July 14, 2010

Are Federal Ozone Standards About to be Lowered?

Currently, the Environmental Protection Agency is in the process of reviewing the ozone national ambient air quality standard. The regulations were last updated in March of 2008, when the agency established a standard of 0.075 parts per million for average exposure over an 8-hour period. In January of this year, the EPA proposed lowering the standard to one in the range of 0.060 to 0.070 ppm in order to “provide requisite protection of public health and welfare,” i.e. the ozone concentration above which exposure is potentially harmful. Since that time, the agency has been accepting comments and supporting materials as well as public submissions both in favor of and opposing the proposed increase in standards. The EPA is due to release the final rules by August 31, 2010.

As you know from our last post, Ozone is currently used as a sterilant gas in the healthcare industry. Because of the health affects that exposure to ozone can have on the eyes and respiratory system, OSHA has set an 8 hour time-weighted average permissible exposure limit (PEL) of 0.1ppm. The OSHA PEL has not been updated for nearly forty years, and perhaps it is time for OSHA to revise its PEL for Ozone in light of the current scientific data. With such minute amounts of gas able to cause significant health problems (the NIOSH immediately dangerous to life and health limit is just 5ppm), it would be extremely difficult if not impossible to immediately identify a leak without a continuous area monitor. Continuous monitoring is about to become even more important to employee safety, assuming the proposed regulations become final.

For access to the proposed regulations and supporting materials, visit:

Thursday, July 8, 2010

Why Do We Have Ozone Action Days?

Yesterday, over 50 cities in the United States declared Air Quality Action Days to protect their population from potential over exposure to hazardous gases and particles in the air. One such harmful gas found in the air we breathe is Ozone (O3). Here in Pittsburgh, we’re in the middle of quite the heat wave, with high temperatures in the low to mid 90’s the last several days. Yesterday’s Air Quality Index (AQI) reached 115, which converts to 81 parts per billion of Ozone in the air. The government considers this number to be unhealthy for sensitive groups, such as those with lung diseases (including asthma), children, older adults, and people who are active outdoors.

According to, even low levels of ozone can cause health effects for those exposed. These effects include:
• Difficulty breathing deeply
• Shortness of breath or painful breathing
• Coughing and sore throat
• Inflammation and damage to lung lining
• Aggravation of lung diseases
• Increased frequency of asthma attacks
• Continuing damage to the lungs even when the symptoms have disappeared

In terms of occupational exposure, OSHA set an 8 hour permissible exposure limit at 0.1 parts per million, which is only .019 parts per million higher than what was in the air in Pittsburgh yesterday. Furthermore, NIOSH set an Immediately Dangerous to Life and Health number at 5 parts per million.

What should we take away from this? The government monitors the air we all breathe because of the harmful effects of gases like Ozone. Shouldn’t employers monitor the air that workers breathe too? Considering that Ozone sterilizers used in healthcare can have tens of thousands parts per million in the chamber, it wouldn’t take much of a leak to cause serious health problems or even death!

Visit to learn more about Air Quality Action Days, and other harmful effects of air pollution.

Tuesday, July 6, 2010

Sterilization Industry Trends

Last week, MD Publishing posted a new Roundtable discussion about sterilization equipment, in which 3 experts explained trends in the industry. Dr. Richard Warburton, our CTO and General Counsel, used the opportunity to discuss a major trend in the sterilization industry that the experts neglected to point out: that of increased awareness of employee safety. Dr. Warburton explains that “With greater education and awareness of the hazards, improved design of the sterilizers, increased use of continuous gas monitors, and wider implementation of engineering controls and PPE, the use of sterilant chemicals in healthcare is becoming safer every day.” Unfortunately, while this seems to be one of, if not the, most important trends over the last several decades, it was barely mentioned in the article.

To read Dr. Warburton’s full comments, as well as the article, visit:

Tuesday, June 29, 2010

NIOSH Report Contains Interesting Information

The National Institute for Occupational Safety and Health (NIOSH) released a report in August of last year titled, “Evaluation of Worker Exposures to Peracetic Acid-Based Sterilant during Endoscope Reprocessing.” The document analyzes a 2006 visit to a hospital that requested a health hazard evaluation because of health problems being reported among employees in their sterile processing department. The report contained a few interesting things relevant to the work that is currently taking place at ChemDAQ.

First was NIOSH’s acknowledgement of the possibility of chemical spills, leaks and processor malfunctions. The report states that exposure is “unlikely”, however at the same time instructs hospital managers to “make sure that processors are inspected periodically for worn parts that can cause leaks” and urges employees to “follow standard operation procedures for processor problems, leaks, and sterilant spills.” While many manufacturers will assure their customers that continuous monitoring of sterilant gases is unnecessary because their equipment cannot malfunction, the NIOSH report makes it very clear that is not the case. According to the report, “processor malfunctions and improper handling and disposal of … containers can result in dermal or inhalation exposures”, as can what NIOSH terms “nonroutine events.”

The second is that this particular hospital had inadequate ventilation of their sterilization rooms and the employees had insufficient training. Without proper training, these workers could experience increased exposure in the event of an adverse incident, which was what prompted the NIOSH evaluation in the first place.

This report once again confirms that sterilizers can and do malfunction and that many workers have insufficient training when it comes to dealing with chemical leaks in the workplace. Without a continuous gas monitoring system, employees would have no way of knowing when chemical sterilants are in the air. This particular report mentions detection of Peracetic Acid by odor, but if you can smell it, it is too late as exposure has already occurred. Furthermore, with inadequate ventilation of the workplace, as in this case, odors from various other chemicals could be in the air, making it difficult to distinguish the harmful from the innocuous. Continuous monitoring enables immediate notification of a leak, allowing employees to exit the area quickly and safely.

To read the full report, visit:

Thursday, June 24, 2010

Environmental Working Group Study

In December 2007, Environmental Working Group published a study entitled “Nurses’ Health and Workplace Exposures to Hazardous Substances”. The study was based on a survey of nurses who reported varying levels of exposure to common chemicals found in hospitals. What they found was quite remarkable, and speaks to the importance of area monitoring in the workplace. A few interesting excerpts:

“Participating nurses who were exposed frequently to sterilizing chemicals, housekeeping cleaners, residues from drug preparation, radiation, and other hazardous substances report increased rates of asthma, miscarriage, and certain cancers, as well as increases in cancers and birth defects, in particular musculoskeletal defects, in their children.”

“Asthma rates increased by up to 50 percent for nurses reporting high exposure to disinfecting and sterilizing agents (glutaraldehyde and ethylene oxide), housekeeping chemicals, and latex, relative to nurses with lower exposure to these hazards.”

“Nurses reporting high exposures to ethylene oxide and antineoplastic drugs also reported up to 20 percent higher incidence in miscarriage, on average, than nurses with lower or no exposure.”

“46 percent of nurses report feeling that the administrations at their health care facilities are not doing enough to protect them from hazardous exposures, and 37 percent do not think that occupational health is taken seriously at their place of employment.”

In light of these results, Environmental Working Group offered suggestions and recommendations to improve worker safety, saying that “(health care facilities) should monitor the air, surfaces, and even nurses’ bodies for chemicals. They should educate nurses on the hazards and safe use of chemicals and other hazardous agents. And they should not wait for these actions to be mandatory.”

We couldn’t have said it better ourselves.

To read the entire study, visit

Monday, June 21, 2010

AAMI Announces Teleconference Dates

The Association for the Advancement of Medical Instrumentation has announced dates for two important teleconferences next month in order to review remaining comments on their standards. The call for Working Group 40: Steam Sterilization Hospital Practices, will take place on Tuesday, July 20 from 10am – 2pm (EDT). The call for Working Group 61: Chemical Sterilants Hospital Practices will take place 2 days later on Thursday, July 22 from 10am – 2pm (EDT). The two documents being reviewed are ST79 and ST58, respectively.

As you might recall from an earlier post, the meetings in May were not long enough to allow discussion on many of our company’s comments concerning the standards. While we all know that exposure to chemical sterilants can be very harmful, the standards are inconsistent when it comes to how they should be monitored. Our goal is to introduce consistency in the documents on how all sterilants should be monitored, with employee safety at the forefront.

We look forward to healthy discussion via the teleconferences at the end of July.

Friday, June 18, 2010

ChemDAQ Continues Work to Protect Employees from Exposure to Peracetic Acid

It’s been a busy week here at ChemDAQ. On June 15, our company applied for a Peracetic Acid (PAA) sensor to add to our Steri-Trac® gas monitoring system. To read the entire press release, visit: Along with Ethylene Oxide, Hydrogen Peroxide, and Ozone (which we also produce sensors for), PAA can be a potentially dangerous chemical if employees are exposed to it in the workplace. While the effects of PAA are known to authorities, they are largely unknown by the general public. Here at ChemDAQ, we’ve done our due diligence to research exactly how harmful exposure to PAA vapor can be.

PAA is used in many different industries including waste water disinfection, aseptic food packaging, medical device sterilization and disinfection in hospitals to name a few. Production of our new sensor, therefore, will enable employers to protect a whole new category of workers from adverse health effects. According to the National Institute for Occupational Safety and Health (NIOSH), PAA is a primary irritant as well as a known tumorigen and mutagen. The New Jersey Dept. of Health and Senior Services released a study in 2004 citing it as a possible animal carcinogen with ties to cancer of the lungs. The study also found that PAA is very irritating to the skin, eyes, nose, throat, and lungs. In fact, the vapor is so irritating that permanent scarring of the skin, cornea, and throat can occur. Higher exposures in the short term can also cause pulmonary edema as well as liver and kidney effects. The entire New Jersey report can be found at

According to the United States National Library of Medicine, exposure to PAA vapor can cause long term effects as well. Espophageal, gastric, and pyloric strictures and stenoses can occur, which may not appear until months or years later. In addition, exposure could cause circulatory collapse that, if not corrected, could lead to renal failure as well as lesions on the heart and liver.

Needless to say, PAA vapor can be quite harmful. As far as we know, the PAA sensor that we have just applied for a patent for is the first of its kind in the world. It will enable employers to continuously monitor for concentration of PAA in the air, allowing them to adhere to exposure guidelines that do exist. The EPA has issued Acute Exposure Guideline Levels (AEGLs) for PAA and OSHA has Permissible Exposure Limits (PELs) for Hydrogen Peroxide and Acetic Acid, the two main components of PAA. It is important to note that, according to the EPA, “although a contributing affect of acetic acid and hydrogen peroxide cannot be ruled out in the toxicity studies described in this report, it appears, however, that acetic acid and hydrogen peroxide are considerably less toxic than peracetic acid”.

Also mentioned in the EPA’s report is the Emergency Exposure Indices (EEI’s) developed by the Belgian PAA manufacturer, SOLVAY. The values correspond to the following:

SLV-EEI-3 (death/permanent incapacity) 50ppm: the threshold above which mortality and/or irreversible effects could be observed for an exposure of up to 60 minutes.
SLV-EEI-2 (disability) 3ppm: the threshold level above which intense lacrimation, extreme nose discomfort and transient incapacitation (inability of self protection but without residual consequences) could be observed for an exposure of up to 60 minutes.
SLV-EEI-1 (discomfort) 0.15ppm: the threshold level above which discomfort could be observed for an exposure of up to 8 hours per day.

Take it from the people who manufacture it – PAA can be quite hazardous, even in small amounts.
For further information, all of the EPA’s findings can be found at

If you or someone you know has had any adverse effects due to exposure to PAA vapor, we invite you to share them here.

Thursday, June 10, 2010

Just What is a Part Per Million of Sterilant Gas?

As you know, here at ChemDAQ we produce toxic gas monitoring systems with the safety of workers as our first priority. You are also probably familiar with the current regulations pertaining to chemical sterilants. For example, the OSHA Permissible Exposure Limits (PELs) for Ethylene Oxide (EtO) and Hydrogen Peroxide (H2O2), two common sterilant gases, are 1.0 part per million (ppm). For Ozone, the PEL is 0.1ppm. In dealing with gas, which has an incredible amount of particles, it is difficult to understand just what a part per million really is. So to make it a little easier to comprehend, we’ve come up with a few analogies:

A ppm is…
The first step of a 380 mile walk.
One hair on your head and on the head of nine of your friends.
One second out of 11.6 days.
One penny out of 19 - 5 gallon water jugs filled with pennies.
One drop of water (.05ml) in a 13 gallon tank.

Now that you have an idea of just how small one ppm really is, consider this. The average sterilizer uses several percent by volume of the active sterilant gas in the chamber. Just one percent of that volume is equivalent to ~10,000ppm. Therefore, even the smallest leak or simply the off gassing of sterilized equipment could release an amount of toxic gas into the breathing zone capable of significantly affecting the health of those exposed. Without a continuous monitoring system, workers wouldn’t know that they were being exposed until the concentrations of gas in the air have reached levels far above the PELs, thus putting their health in jeopardy.

Monday, June 7, 2010

ChemDAQ Continues Work to Update AAMI Recommendations

On May 24th and 25th, representatives from Chemdaq attended the Association for the Advancement of Medical Instrumentation's (AAMI) committee meetings for the Chemical Sterilants Hospital Practices and Steam Sterilization Hospital Practices working groups to contribute to the revisions of ST58 and ST79, respectively. Seeing as these recommendations are only updated every 5 years, there was much to be discussed at the meetings. Understanding the serious health effects of chemical sterilants, and as a leader in the field of continuous gas monitoring, we are seeking to introduce consistency into AAMI's recommendations on how such sterilants are to be monitored. We feel that continuous gas monitoring of substances such as Hydrogen Peroxide, Ozone, and Peracetic Acid is the only way to effectively meet OSHA regulations given today's technology and seek to have those recommendations established by AAMI. Unfortunately, the meeting was not long enough to reach all of our points, and discussion will continue via teleconference in just a matter of weeks. Assuming the other members of the committees see these issues our way, revised versions of ST58 and ST79 will be voted on this coming November with our comments included. We'll keep you updated on our progress.

In the meantime, below I have posted an article writted by our own Dr. Richard Warburton concerning the misconceptions people have regarding today's chemical sterilants. It was published in May 2008 in Infection Control Today. Hopefully this article will provide further justification for why toxic gases should be continuously monitored in the workplace.


Wednesday, April 28, 2010

ChemDAQ Inc. I'm not sure how I missed this article but it supports ChemDAQ's position that Hydrogen Peroxide used in vapor and plasma form should be monitored to assure worker safety. Even though OSHA has established a Permissible Exposure Limit (PEL) many employees and employers allow themselves to be lulled into a false sense of... security by their familiarity with common forms of LOW concentration H2O2.

Chemical leak forces evacuation at Eisenhower Medical Center in Rancho Mirage Inland News
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