Disclaimer: This summary consists of informal notes compiled by OSHA notetakers at the designated stakeholder meeting. They are not verbatim records and are intended merely to summarize the major points raised at the meeting. All issues related to a proposed rule for silica are still being discussed within the Agency and with interested stakeholders; no final decision on any issue has been reached.
OSHA SILICA STAKEHOLDER MEETING
SESSION 4 - September 16, 1999
1:30 a.m.-5 p.m.
SESSION 4 - September 16, 1999
1:30 a.m.-5 p.m.
The format of the stakeholder sessions followed the questions in a stakeholder document that is also available on the Web page. There were four general areas of discussion: scope, controlling exposures to crystalline silica, monitoring and sampling, and health screening and surveillance.
The OSHA panel began the conversation about silica regulation by stating that the Agency is open to discussing all issues but is particularly interested in several issues:
- Controls for high hazard operations
- Qualified person requirements
- Sampling and analytical methods
- Research on different forms of crystalline silica.
The panel then posed these questions:
- Are there other industries, of which the Agency is currently unaware, that are likely to be affected by the rule?
- Should the Agency regulate different forms of silica in the same way?
- How should the Agency treat encapsulated materials?
A foundry representative asked the OSHA panel:
- Does the Special Emphasis Program (SEP) for Silica reveal the number of establishments that have exposures above the PEL?
- Has there been any prior effort to enforce at those workplaces?
He said that stronger enforcement might improve the situation.
The OSHA panel responded that enforcement was ongoing before the SEP and is still continuing, but enforcement alone is not enough. The Agency has preliminarily concluded that a comprehensive standard is necessary to address the health risks from crystalline silica. The IMIS system tracks OSHA's compliance inspections and maintains some data on them.
A representative from an employee-owned foundry stated that his company had been inspected by OSHA and has spent almost $3 million on engineering controls. He wanted to know if they could rely on respiratory protection, given the high cost of these controls. There are some operations for which they must rely on PPE (personal protective equipment) for employee protection; for example, maintaining and cleaning bag houses. He further stated that some of his competitors have not been inspected, and his foundry is, therefore, at a competitive disadvantage.
The OSHA panel responded that its standards generally follow the hierarchy of controls, which requires that feasible engineering and work practice controls be used, before PPE is used. However, as guidance for the Agency in developing the standard, OSHA needs exposure information to use in evaluating the effectiveness of various control methods.
The foundry representative replied that there are a total of 120 employees at his facility; of these, 35 employees are exposed near, or above, the current PEL. However, there is considerable variation in exposure results in the day-to-day sampling of employees in some jobs.
A representative from a large, captive foundry said that his company produces a high volume of relatively complex castings. He said the company has continually made large investments in the process for better quality, higher productivity, greater environmental awareness, and other reasons. Over the past 20 years they have made tremendous advances, such as: the enclosure of foundry processes, automation, and using substitutes for sand. He stated that his facility is in compliance with the current PEL and employees do not use respirators.
Another foundry representative stated that his company had never had a case of silicosis, and the need for a standard is not apparent to him. OSHA should explain why a comprehensive standard is necessary. The representative said he had attended conferences for information, but had never gotten feedback on the results of the SEP.
The OSHA panel responded that the information and documentation to justify the proposal will be in the preamble to the proposed rule, and that OSHA will provide outreach material. The SEP information is entered into OSHA's IMIS system, and is available to the public through OSHA's home page; however, the data is not specifically identified as SEP data. The Agency is preparing a summary of the data and will post it on the web-site when it is complete. The OSHA panel explained that the Agency has requested copies of the SEP case files for closer analysis.
Another foundry representative stated that engineering controls are not always effective. He said:
- If OSHA lowers the PEL, will there be flexibility in controls to comply with the new PEL?
- If OSHA lowers the PEL to 50 micrograms per cubic meter (50 ug/m3), we will not be able to measure effectively at that level.
The OSHA panel replied:
- The Agency usually develops performance-based standards except in some specific situations.
- The Agency needs stakeholders to provide data showing that there have been no health problems connected with silica. OSHA could then consider that data.
- Currently, the Agency quantifies the risk based on the data available. It is not unusual in health standards--where ten or twenty out of every 1,000 employees may have an adverse health impact--that many employers, or even most, may not have a case of disease in their plant. This is especially true in the case of silicosis because of the long latency of the disease.
A representative from the Silica Coalition asked if analysis of exposures and any resulting silicosis cases would be available before the regulation is promulgated. He asked for reports on silicosis cases and the exposures of those employees developing silicosis. He also mentioned the issue of polymorphs and the different effects that may result from exposure to each.
The OSHA panel explained that the Agency has yet to determine what reports would be prepared from the exposure data; however, the results would be used for a feasibility analysis. In answer to the request for data on silicosis cases, the panel referenced the SENSOR project (seven states, 640 cases of silicosis).
A physician with experience in the granite industry stated that the PEL is critical. He explained:
- The granite industry has controlled dust since 1940, investing 10 to 20 million dollars to that effort.
- Exposure levels were brought down: Fifteen to 20 percent of employees are exposed at, or above, 60 ug/m3 (as an 8-hour time-weighted average (TWA)) and 80-85 percent of employees are experiencing lower exposures.
- Previously, Vermont had the highest death rates from silicosis, 31 deaths in 15 years, however, all of these workers were employed prior to 1940. Back then, 27 percent of employees in the industry had silicosis.
- Medical surveillance of the granite industry in 1983, after controls were in place, showed that 6 out of every 1,000 workers tested showed some nodules, and this group of workers was exposed for an average of 20 years at OSHA's current PEL.
He concluded by saying that it seems clear that the high rates of silicosis in the past were a result of exposures well above OSHA's current PEL. Having industries comply with OSHA's current PEL would vastly reduce cases of silicosis.
An MSHA representative reported that she had seen silicosis cases in 6-9 percent of workers who are between 40 and 50 years old in surface mines.
A representative from clay manufacturing stated he had never heard of silicosis occurring in that industry. He continued:
- There is a problem with lab sample analysis.
- One can analyze for the silica polymorph, but the analysis says nothing about what actually gets into the lungs.
- In this industry, silica is usually encapsulated, or occluded, in clay particles. He referred to a study conducted on the silica content of kitty litter, and he offered to provide a copy of the study to OSHA.
He concluded by urging OSHA not to regulate all crystalline silica, only the forms that are hazardous. He remarked that IARC (International Agency for Research on Cancer) had ignored a codicil from its own working group in its determination that crystalline silica was carcinogenic.
A representative from the color pigment industry said that this industry has low exposures to crystalline silica, although there is evidence of trace quantities of silica bound to a matrix of other materials. He said the industry does not manufacture products that generate crystalline silica.
The OSHA panel responded that if the color pigment industry exposures to silica were non-detectable, the rule would have little impact on that industry.
A representative from the Silica Coalition urged OSHA to do a study of the SEP data, mentioning that NIOSH had performed a study showing the frequency of exposures above the current PEL.
A representative from a foundry society said:
- His industry is so diverse that a 'one-size-fits-all' approach in a regulation will not work.
- In the past 25 years, the number of foundries in the U.S. has declined from 5,000 to 3,000, and many have moved to other countries.
- Most of the foundries still rely on green sand for molds. This sand is a combination of river sand, bentonite, and other materials.
- The industry needs good, open dialogue with OSHA, DOE, and EPA.
- It is critical that Federal agencies co-ordinate their regulatory efforts so that industry can more easily comply.
A union representative asked for a separate construction standard. He referred to the New Jersey Partnership study of silica exposures in road repair and construction. The study results showed three to five times the PEL in jackhammer and drilling operations.
The OSHA panel replied that the Agency was considering a construction and maritime tier but one single rulemaking.
Responding to comments from a clay manufacturing representative regarding freshly fractured quartz, the OSHA panel said that current technology does not tell us whether or not silica is freshly fractured. The OSHA panel said that NIOSH is trying to identify the toxic mechanisms of aged silica.
A road building equipment manufacturer stated that there are widely different exposure levels resulting from different processes in the industry.
The OSHA panel asked for feedback on controls for specific processes, such as cutting and drilling, and regulated areas. The panel asked if the use of compressed air (for blowing down) should be prohibited.
A representative from an employee-owned foundry stated that olivine sand is four to five times more costly than silica sand, and it may not be safer. Studies have not been done on olivine sand; the industry will need to perform the studies, especially if the PEL is lowered. For protection from silica, the respirators and ventilation equipment required are expensive to maintain, the LEV (local exhaust ventilation) wears out, and replacement equipment is expensive. Although his company has been able to expand, global competition has caused the industry overall to lose business (to China, for example). To clean the air further will render the industry even less competitive due to the high costs.
An auto manufacturer representative said his company has substituted materials, as well as enclosing processes and installing LEV. The sand-substitute particles are more uniform than are silica particles, and they are heavier, so exposures may be lower. Exposures in his foundries are below the PEL; however, he did not know how significant the exposure reduction is. Enclosures are a high priority and ventilation is used. For older processes, employees need to wear respirators in the vicinity of the operations. Also, wet methods often cannot be used in a foundry. He recommended quarterly exposure monitoring.
Regarding hygiene facilities, a Silica Coalition representative questioned the value of--or rationale for--requiring hygiene facilities, such as showers and changing rooms. He asked whether or not gastric cancer had been carefully studied. He then went on to report that in his experience journals exhibit publication bias. For example, he submitted an article about an authoritative study showing no correlation between silica and lung cancer, and the article was rejected. However, that same journal accepted a study showing a positive correlation that was statistically insignificant. The latter study attempted to show a relationship between gastric cancer and silica exposure.
The OSHA panel replied that hygiene facilities are necessary to prevent stirring up dust, spreading it to the car, taking it home, and inhaling it. Gastrointestinal cancer through ingestion would not be the focus of the standard.
The Silica Coalition representative responded that their searches of the literature had failed to find any relationship between gastrointestinal (GI) cancer and silica.
A small foundry representative said it is easier for a small parts manufacturer to have engineering controls. He said:
- His company uses respiratory equipment and practices job rotation; however, employees do not want to wear respirators all day. It is already hot in foundries, and becomes hotter for the employee when PPE is used.
- Foundries are cited for not having engineering controls.
- Foundries would like guidance on how much money they are expected to spend. OSHA has the power to put us out of business. We have 425 employees at 3 facilities.
The OSHA panel explained that an economic analysis is done on each affected industry. OSHA has the burden of showing economic and technical feasibility. Once OSHA makes this finding, the burden shifts to the employers to explain why they cannot meet the standard in their specific case. The panel said that the impact of a new standard is not designed to upset the competitive balance of industry. The Agency estimates the cost of the program, and considers the impact of costs on prices and profits. The more knowledgeable OSHA is about the industry, the better the economic analysis can be.
A representative from a foundry society stated that many facilities are old, although there are some new plants. He added that:
- One cannot simply place new ventilation systems into old facilities with old processes.
- There is a shortage of technical people for designing good ventilation systems.
- The abrasive nature of silica wears out the duct work on a periodic basis; elbows may last only one or two years. Duct work is not really a long-term capital expense.
- It is already burdensome to comply with EPA's air cleaning equipment requirements, namely, a bag house and scrubbers; complying with OSHA's requirements would be an additional burden.
Another foundry representative added that his company has invested heavily in order to comply with OSHA's Lead Standard. It has added many engineering controls and pays a lot more attention to housekeeping. He said:
- The company has done a lot of work with ventilation.
- Wetting sand for sweeping doesn't work.
- A centralized vacuum system cost $52,000 at a facility of 50 employees. Experts were unable to predict how well it would work, and it didn't. Another $20,000 was necessary to reconfigure the system.
- One problem is that portable vacuum hoses clog.
- Dust sits on the joists of roof trusses, and vibration causes it to become re-suspended in the air.
- To protect against lead exposure, the company cleans once a year; vacuuming is ineffective.
- Vacuuming overhead results in ergonomic problems.
- Much of our work has gone offshore. The company has been able to maintain production in niche markets for non-ferrous products, but opportunity for economic growth is not there.
A representative from the Silica Coalition suggested that they could wash down the trusses in their plants.
Another foundry stakeholder stated that he would prefer a performance-type standard; however, for high exposure operations, OSHA should identify which controls foundries need to have, and should make it clear that foundries will not be cited if they do have those controls and yet still exceed the PEL.
A representative from a small foundry asked OSHA to consider the little guy, saying: there is a big difference between a small foundry and a major corporation.
A representative from a union urged that the Agency should be sure to address drivers of ready-mix concrete trucks. The union has anecdotal data that suggests there is a problem. A dispatcher at a concrete plant in Region Two developed silicosis. The representative suggested that OSHA talk to its representatives in Region Two for information about this case. She further stated that workers periodically have to enter mixing vessels to clean them. Workers are not protected while performing these tasks. There is no surveillance, and only dust masks are provided.
In response, a representative from the Silica Coalition reported that NIOSH has information on ready mix concrete.
The OSHA panel replied that OSHA would look at concrete facilities carefully.
An equipment manufacturing representative asked how specific the standard would be in specifying controls. Will it address each industrial procedure to demonstrate feasibility?
His experience in construction was that most people prefer to follow general guidelines when complying with standards.
The OSHA panel responded that the feasibility analysis looks at each process separately.
MONITORING AND SAMPLING
The OSHA panel expressed its interest in monitoring strategies as well as in sampling and analytical methods. The panel asked for suggestions on more cost-effective ways to assess exposures. Also, it asked whether or not there should be an action level in the standard.
A representative from the Silica Coalition stated that American Industrial Hygiene Association (AIHA)-accredited laboratories need to be included in any round robin testing. The coalition thinks the current variability between labs is a serious problem. A 16 percent variation between labs is too high; the variation should not exceed 12.8 percent. The representative asked that OSHA speak to NIOSH regarding variation between labs to clarify the issue. He suggested that OSHA have a public meeting on the variability issue.
A foundry representative said his company uses personnel from the State of Ohio to sample once a year, at no cost. OSHA found levels 5 to 15 times higher than the State. Who should the employers believe? How will they know what to do, or how to proceed?
The OSHA panel replied that the Agency would address the issues of sampling and analytical methods and recognizes that these are serious issues in the case of silicosis.
In response, the representative from the Silica Coalition asked OSHA to examine the reference standard. If Brazilian quartz is used, the measured exposures go up 30 percent, he said. Comparison of 400 paired samples had resulted in a coefficient of variation of 40 percent. Further, there is a problem with National Institute of Standards & Technology (NIST) running out of crystalline silica reference material, which labs need to calibrate their instruments.
A stakeholder from an automotive foundry asked if the standard would be flexible so that the industry can use new technology when it is available. His foundry supports the action level concept, as long as it is high enough to measure. However, with a PEL of 50 ug/m3, an action level of 25 ug/m3 is too low to measure accurately. His company now monitors homogeneous groups on a set schedule. Monitoring frequency is reduced when exposures become very low.
A representative from the foundry society asked if rulemaking would be delayed until laboratory analysis is improved. There are several developments in technology that may become available, for example, the new cyclone. The members of the foundry society need the following:
- A clear understanding of the matrix interferences, compounds, and the amount of quartz in the sample.
- Guidance on how to collect air samples, how to calculate the results, and information on the reliability of quartz analyses.
- Knowledge of the exposure variability of the epidemiological studies on which the risk assessment will be based.
The OSHA panel replied that the Agency would look into all these sampling issues and would explain them as well as possible in the preamble.
HEALTH SCREENING AND SURVEILLANCE
The OSHA panel asked:
- Should health surveillance information be reported to NIOSH?
- Should medical removal protection (MRP) be included in the rule?
- Whether or not to require second opinions.
A B-reader from the Vermont granite sheds stated that:
- Exposures in the industry today are about 60 ug/m3 as an 8-hour time weighted average (TWA).
- He recommended X rays in 5 year increments for at least 20 years. X rays are not necessary on the first day of work if the exposure level is below the PEL.
- Under the International Labor Organization (ILO) system, a reading of an X ray as 1/0 will usually be related to age, smoking, and other things, such as asthma. However, aging and smoking usually affect the lung's lower lobes, while silica affects the upper lobes.
- Since the measurement 1/0 is tentative, it is more accurate to use 1/1.
- A questionnaire will not tell us if the patient has silicosis.
- No deaths have been reported from silicosis since 1940 out of 4,500 people exposed.
- Many of his patients with silicosis do not have much impairment in lung function or lifestyle for 10 or 15 years after onset. In most cases the disease is not as terrible as its reputation.
An MSHA representative commented on the progression of silicosis, saying that the severity may be determined by whether or not the X rays change over a period of time.
A representative from the Silica Coalition said the 1/0 should not be the threshold for a determination of silicosis. The ILO 1/0 criterion should be used only to "suspect" silicosis; it is not necessarily indicative of silicosis. A reading in one year could be 1/0, and the following year be 0/1. Therefore, OSHA should have 1/1 as the criterion because it is a better indication of silicosis. He recommended baseline X rays. Then, based on the date of first exposure and the individual's age, take X rays every two years.
A representative from an automotive foundry said that his company can establish programs for their employees, yet unions are still suspicious of their efforts. Also, dentists and doctors usually prescribe X rays less frequently than every two years. People fear radiation from X rays; therefore they need an explanation of why an X-ray test is beneficial more often.
An MSHA representative said that coal miners are provided X rays by law. Therefore OSHA should do the same for silica-exposed employees. While employees may be reluctant, they do have to be concerned about contracting disease.