Beryllium Public Forum--Albuquerque
(DISCLAIMER: These meeting notes are not
a word-for-word transcription. In some cases,
speakers have been paraphrased.)
January 15, 1997
C. Rick Jones presented opening statement. Current standards were adopted by the Department in 1970. Subsequently, DOE experienced a significant reduction in incidence rates. New monitoring techniques developed over the past 10 years have enabled DOE to identify workers with signs of beryllium (Be) disease resulting from exposures below the current standard. A small amount of Be work is still being done. As D&D work picks up, this could put more workers at risk.
Purpose: To provide DOE with information and allow speakers to present their views.
Mark Hoover, Industrial Hygienist, ITRI: "IH Experience Supports Controlling Beryllium Exposures to Levels ALARA"
Hoover suggested controlling Be exposures to levels as low as reasonably achievable (ALARA). He maintains that the current permissible exposure limit (PEL) may not be protective for everyone. Workers who are only casually exposed to levels below the PEL have become sensitized and have developed the disease. Among the population, there is a sensitization rate of 2% to 4%. There may be a dose-response relationship that leads to development of chronic beryllium disease (CBD). Therefore, adequate industrial hygiene practices may help in preventing clinical development of CBD.
Critical issues are:
* To minimize inhalation exposures
* To develop guidelines for ALARA practices
* To improve tools for controlling exposures, especially the Be real-time monitor
* To characterize the important aerosol properties in the workplace (size, chemical form, etc.)
* To correlate rates of CBD with exposures to establish a technical basis for controls
DOE should avoid distractions such as arguments over a new value for the PEL. There’s no technical basis for a new value. Artificial selection of a new PEL would divert attention and resources from critical needs. ALARA provides the most expedient route to protection. Hoover thinks that the current ACGIH excursion limit recommendations for substances without STELs are adequate. There is no technical basis for a specific STEL.
In research at Lovelace (formerly ITRI), they have seen no evidence of differences in physical reaction (macrophage kinetics) to episodic vs. continuous Be exposures. There’s no basis in the way the particles are handled in the lungs for saying that there would be any difference, as long as the TLV TWA is maintained.
As for ALARA, proper guidance is necessary so that we don’t fall into the same trap as they did in health physics: you never know when you can stop, and you’re always subject to second guessing. So, it may be necessary to develop a maximum dollar value per avoided exposure. It might be dollars per microgram per cubic meter-hours. It might be tied to the PEL as an action level. As you go lower and lower, the payoffs have to be obvious and the costs have to be lower. An action limit lower than 0.5 mg/m3 would unreasonably divert resources by requiring exceptionally intensive efforts to verify that you are not above the action level because of the sampling times required and the sensitivity and uncertainty of the measurements.
Should the PEL apply to respirable particle mass? We know that the deep-lung deposition of Be particles is of the greatest concern. Particles going in the nose and upper respiratory tract probably have no impact at all on the induction of CBD. However, a change of the current PEL to consider only respirable fraction would require setting a new PEL. There is no technical basis for setting a PEL based on respirable fraction. However, respirable fraction should be considered for focusing control efforts.
Recommendations:
* Develop a Manual of Good Practice.
* Support basic and applied research related to these issues.
* Support development of the Be real-time monitor. (By October, they should have a
commercially available version of the monitor developed by Los Alamos.)
* Continue to support studies involving workplace exposure characterization and the
natural history of CBD. We have to be able to relate the risks to the aerosols so we
know where to focus our limited IH resources.
Question from Weitzman: Do you have additional information about the reasonableness (dollars involved) of using the ALARA principle? Any ideas about developing a useful algorithm for determining what that cost would be?
Hoover: The first thing I would do is put together a series of examples of how jobs could be controlled better; this could be contained in the Manual of Good Practice. It might be very practical lessons learned from around the complex. People can look at the way they’re doing things now and look at whether changes would be economical. Then, it might be possible to develop an algorithm; for example, how much time will it take to do an air-flow study in a room and how much would that cost. There are hazard potential calculations that have been recommended by NRC--NUREG 1400 (Eva Hickey’s work at Pacific Northwest Laboratory). We could adopt some of those. Some of the original indicators like surface contamination are of very limited value (depending on particle size, composition of the surface, etc.). In fact, if we were to have workers spending extra time in the workplace cleaning surface contamination, we could be adding to their overall exposure.
Question from Sikora: Did you have any recommendations for other program elements (e.g., medical surveillance, formal monitoring)?
Hoover: I think it’s best if I defer to other experts who will be addressing the lymphocyte proliferation test (LPT), chest X-rays, pulmonary function tests. However, I would like to relate a couple of my personal feelings about the medical surveillance program. The Department is struggling with the definition of a Be worker and whether such a worker should be required to have an LPT. I worked with Be for more than 15 years at Lovelace and I have not yet had the LPT. I have no clinical symptoms, no indication that I have CBD. I don’t believe I’ve ever been exposed above the PEL. This is a personal decision I have to make, especially as a researcher. The problem I have is, if I should ever become involved in an episodic exposure, where I’m enveloped in a cloud of Be, am I going to wonder at what point did I become sensitized? Should I know this ahead of time; should I get the LPT test now? If a trained IH professional is wondering about that, that is indicative of the controversy over how these numbers might be used.
Question from Nadeau: You mentioned using dollar value per avoided exposure as a basis for cost effectiveness. Can you cite references?
Hoover: If we’re looking at standard OSHA exposure risk, we could use a dollar value. The problem with CBD is the extent of health damage and the value. Is there, say, a third of workers with CBD who have no impairment and lead a normal life, one third who have some sort of change (shortness of breath, etc.), and one third who have more serious impairment? How do we apportion this in a realistic way? For radiation exposures, we may spend a million dollars to eliminate a rem or a millirem of exposure. We know that those have no practical consequence for worker health. There might be a one in a million chance that a worker might come down with cancer from that exposure. The normal risk in industry might be one in 10,000. Why are we spending the money?
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Gregory Finch, Toxicologist, ITRI (Lovelace Respiratory Research Institute):
Animal Toxicology Data with Beryllium Do Not Support a Change in Exposure Standards
Ten investigators are working on these issues at Lovelace. Lab-based animal research is an important component of a program to understand and mitigate Be toxicity.
No one animal model constitutes a good model of human CBD. Some animals respond with many of the features of human CBD. CBD-related effects have been seen in animals only at relatively high exposure levels. There’s no broad mechanistic understanding or correlation between the mechanisms of response in animals vs. humans.
Inhaled metallic Be is a pulmonary carcinogen in rats. Lung burdens as low as 17 mg/g of lung tissue caused substantial incidence of lung cancer in rats. Preliminary results from a dose-response study indicate that a carcinogenic lung burden might be somewhat lower. On the other hand, other studies show that acutely inhaled Be is not carcinogenic in mice. This shows a marked difference between rats and mice. Therefore, use of our rat data in a classical risk assessment process does not appear warranted. I would conclude that animal research in the area of cancer does not support a change in the existing exposure standard.
Other findings: Inhaled Be metal has been shown in rats and mice to decrease the ability of the lungs to clear other inhaled particles. Inhaled metallic Be and 239PuO2 combine in a greater than additive fashion to cause lung cancer in rats. Therefore, we’re very concerned about the ability of Be to modify the health risks from other inhaled materials. This type of effect needs to be better understood and considered when considering complex combinations of exposures.
In vivo and in vitro studies show that the physical and chemical forms of the Be influence the toxicity. In particular, the specific surface area is quite important in determining how toxic the particles are. Therefore, different exposure standards might be appropriate for different types of Be.
The work we’re doing in animals is typical in toxicology in that we’re using exposure levels that are quite high in comparison to what humans get. However, when we consider lung clearance (one of the most sensitive indicators of Be exposure in rats), it occurs at levels that could potentially be reached by heavily exposed humans when you normalize the exposures by the weight of the lung. The 1-mg lung burden of Be in rats, when it’s expressed on a per gram of lung basis, in humans that are exposed at the PEL could be achieved within about 140 workdays.
Conclusions and Recommendations: Toxicology research is not advanced enough to support any changes in existing standards. Lab-based animal research is an important component of a program to understand and mitigate Be toxicity to humans.
Weitzman question: We have well-documented cases of individuals with minimal exposure that now have signs of CBD. We’re concluding that human data is cause for concern. You’ve made a case that animal data do not support a change, but there’s more to the equation than just the animal research.
Finch: Exactly. Obviously, human beings are the best model for human beings. The data becoming available for humans are real cause for concern. I and my colleagues share that concern. The two points I wanted to make were: (1) The work we’re doing with animals unfortunately is not sufficiently advanced that we can recommend a different exposure standard. (2) Although the animals do not constitute the best model for humans, the animals can be used to answer certain questions such as those about the different physical and chemical forms of Be.
Jones question: Were your animal exposures episodic or long-term?
Finch: We’ve only used high-level acute episodic environments. We have not put them in an environment that would be comparable to the work environment.
Nadeau asked for a bibliography of the 45 studies.
Comment from Mark Hoover: Wanted to expound on the difference between concerns for cancer and concerns for CBD. Our studies have focused on both. The risks for cancer are so low that they don’t support a change in the PEL; however, some information resulting from the animal research was very important for understanding the basic mechanism of cancer and the interaction of different materials such as radionuclides and beryllium.
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Jerry Evans, DOE-AOO: Addressed programmatic issues. (SEE WRITTEN STATEMENT)
The Federal Register notice had misleading and inflammatory information. Area monitoring done over a long period of time is not capable of showing individual exposures. DOE does not know the exposure history of its workers who have developed CBD, so it cannot conclude that the existing PEL is inadequate.
The current legal and regulatory environment could influence Brush Wellman to cease operation of its Be Metal Products division.
Several recommendations:
* Cease activities to set a standard
* Withdraw Federal Register statements
* Continue to look to OSHA for setting standards
* Continue data gathering and Be research
* Turn over data to OSHA for their consideration
* Continue existing philosophy of rigorous conduct of operations and implementation of
ALARA principle
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John Martyny, Tri-County Health Dept. (National Jewish Center contractor):
Three topics:
Establishment of ALARA as an exposure guideline for Be
Personal monitoring as the primary method of exposure sampling for Be
Recommendations for a medical monitoring program
Shared examples of sensitization from low exposure: an employee at beryllium metallizing operation with no detectable exposures, yet developed CBD. Machining operations below the PEL, where recent employees became sensitized. Eight employees at beryllium operation with average exposures from 0.2 to 1.1 mg/m3 that ended up with CBD. One was a supervisor who theoretically would have had only bystander exposures. Also, a security guard and a secretary with bystander exposures in fairly well controlled areas, both of whom got CBD. The secretary was never even around Be, as far as we can tell.
Suggested an ALARA policy. There are several reasons for that:
(1) There does seem to be a dose response. (Tape ran out)
For many processes, exposures can be controlled with relatively low expense. Monitoring is feasible at these levels with ICP and graphite furnace (AA) methods. More information is becoming available that may allow us to look at specific things like respirable aerosols, particle distributions, etc.
Current Be monitoring methods: lapel sampling, area sampling, real-time (hopefully soon), and combinations of these.
We favor lapel sampling because exposure is similar to employee’s. Unusual events can be captured. If you try to take an area sample around the employee, the employee may change his or her behavior. Employee behavior is less modified with lapel sampling, and IH judgment is less important. Gave an example where IH misjudgment about a plume leaving a machine resulted in higher exposure measurements in the breathing sample than in the sample taken at the point of operation.
Lapel sampling is higher cost, time consuming, and has limit of detection difficulties and increased equipment costs.
We recommend primary sampling using lapel sampling, process diagnostics using area breathing zone monitoring, and particle-sizing samplers. More work needs to be done in the area of wipe and bulk sampling, especially if results are going to be used to look at cleanliness and risk. Wipe sampling does not have much value for correlating with exposures.
Recommendations for Medical Monitoring: Should be a four-pronged process:
1. Initiated by the blood lymphocyte proliferation test (BLPT), given to all workers as a screening tool.
2. Chest radiographs read by a B reader.
3. Epidemiologic information.
4. IH evaluation of the facility.
Initial monitoring should be broad-based. (In one of the facilities we’re looking at now, we’ve found a lot of tracking on the carpet from one building to another.) Follow-up blood testing should be tailored to risk. Former employees should be included. Use of chest X-rays can be reduced.
Weitzman question: Asked for explanation of the various types of sampling used in the study.
Martyny: The breathing zone sample was not actually on the worker’s lapel. The two lapel monitors on the employee were a personal cascade impactor and a traditional 2-L/min total Be sample was collected on the other lapel. The breathing zone was actually a BA area sample that was set where we thought was the closest the person might come to the plume coming off the machine.
Nadeau question: Asked for more details about controlling Be exposures at relatively low expense.
Martyny: We’ve been in a number of facilities ranging from almost no cost for controls to Rocky Flats where they put control on each machine. In some facilities, the primary method of control is the use of coolants. In others, a flexible tube is used by the operator to vacuum. At Rocky Flats, they used a combination of high-volume, low-pressure collection device coupled with a high-pressure, low-volume device, and they enclosed the machines. Need to talk to Rocky Flats about per-machine cost. The reason we’re suggesting the use of ALARA is that, in some machining operations, maybe you can control it down to a tenth of the PEL, whereas there may be operations that would not be as conducive to controls.
Sikora question: Do you have data to indicate the effectiveness of the controls?
Martyny: We don’t. Rocky Flats does have a fair amount of information as they went from LEV to high-vacuum local exhaust and enclosures.
Sikora question: Do you have exposure data to document the exposure history of those who have been sensitized with low exposure?
Martyny: It’s available. The question that comes up is, "Did that person experience an unusual episodic exposure that far exceeded the PEL?" You’ll probably never get to the point where you can positively say that the person was NEVER exposed above the PEL. But, if we start to get a lot of cases that seem to have low exposures but have become sensitized, then it’s worth studying.
Sikora question: Do you have any ALARA recommendations?
Martyny: For many of the processes, we’re beginning to learn what is achievable. Suggested using the Manual of Good Practice to give guidance for types of controls for specific processes.
Sikora question: Could you provide data to support your medical monitoring recommendations?
Martyny: Sure. We intend to provide a lot of written information on that before the deadline.
Sikora question: On medical monitoring for former employees, could you give more details on what that should be?
Martyny: One of the difficulties is a lack of information on the natural history of the disease. Right now we don’t know how long after exposure it is before you become sensitized. Since the LPT hasn’t been employed for a long time, it would make sense to go back and apply it to former workers now. Perhaps make it risk-based, depending on how long the former employee worked around Be and how long the employee has been gone from the work.
Rogers question: Asked for written exposure data for various operations and sites.
Martyny: It’s not easy to do, but we’ll send you what we’ve got. Often, what a company thinks a worker has been doing for 30 years is not what the employee thought they were doing.
Jones question: If there’s uncertainty about a person’s exposure, how certain are we that these persons with little or no exposure actually have CBD? How good is the medical diagnosis?
Martyny: If an employee meets the medical definition (non-caseating [?] granulomas on biopsy, as well as LPT results, etc.), then I think there’s a pretty good chance that they have CBD.
Jerry Evans question: What does CBD really mean (sensitized, further along)?
Martyny: Our definition of sensitized would mean that a lab has performed multiple blood LPT tests that show proliferation, but there might be no outward symptoms. A person with CBD would have granulomas, etc.
Joe Furman: There’s general agreement on the definitions for a majority of the cases. Sometimes it depends on whether you’re trying to define cases for workers comp or for some other reason.
Jerry Evans question: If a person is sensitive and you remove him from the workforce, will that prevent the progression of the disease? If a person smokes, should we automatically exclude them because additional insults may cause additional problems? (ANSWER TABLED UNTIL LATER)
Mark Hoover amplification: Explanation for why the point of operation measurement was less than the BZ measurement. We had wanted to use the Be real-time monitor, but it wasn’t available. There was an exhaust hose on one side of the tool head, and I think we put our sampler on the opposite side. The way we were set up, it’s likely we were drawing clean air across the tool head to the point of operation monitor. I hope the real-time monitor will improve the quality of all the sampling we do.
William Mathis, Epidemiologist, University of New Mexico, question: Specificity of the Be LPT. There seem to be some alarmist reports of people who have had very low exposures but yet are coming up positive on this test. Is the specificity of this test well documented on controlled populations? What is the false positive history for LPT?
A lot of testing has been done--the National Jewish Center. A number of these individuals have not only sensitization but also CBD. When you put the two of those together, the odds of them not having CBD are pretty low.
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Corville Nohava, AOO: Worked at Rocky Flats from 1977 to 1983, now at AOO since 1983. As a lay person, I’m appalled that we don’t have some decent standards for controlling Be exposure after almost 50 years of working with Be in this country. I do recognize that things change over time. While at Rocky Flats, I worked in an administrative capacity as a program analyst, as a budget analyst, and in a couple of different jobs. I was required to go around the various areas of the plant and do floor samples of equipment records, comparing equipment with inventory records. I spent a fair amount of time in the 400 and 800 complex, where Be work was done. After I got notification in June of 1995, asking me if I wanted to be tested for Be exposure, one of the things that struck me as quite interesting was that, when I was at Rocky Flats, there was open access to Be areas with no protection whatever. We didn’t even take respirators in the building; we only used them in the nuclear materials areas. There was a greater recognition of hazards, on my part, anyway, for nuclear materials than for Be. I received no Be awareness training whatsoever. Early in my tenure there, late 1977 or spring 1978, there was a fire at Rocky Flats. I had just returned to the Administrative Building from the 400 area. When the alarm went off, I was told we had a Be fire. I asked one of the DOE health and safety staff members what kind of hazard that presented. I was told there was no hazard unless you breathe Be oxide. In June 1995, I received notification that I could be tested for Be exposure. That was fine with me; I’d just as soon get any reasonable medical checkup to give me a sense of well-being. I’m more than positive that I’m well over the limits in both tests. One test in January of 1996, another in March 1996. They were pretty much consistent. So I had the bronchoscopy done. I find that I do have initial stages of lung inflammation--at the beginning stages of CBD. I’m a living example of someone who had minimal exposures or at least episodic exposures. I’ll be going back in for testing this spring and probably annually for the rest of my life. There are probably a lot of other folks out there in the same position. I have to give the Rocky Flats Be exposure assessment team a pat on the back. I do have concern about funding for that program (with budget cuts at Rocky Flats, etc.).
Mentioned a study at the University of Vermont for testing individuals with a pre-disposition for Be sensitivity.
Another comment about DOE practices at Rocky Flats: During my tenure at Rocky Flats, the contractor had different procedures for working with Be than were used at other facilities. DOE should explore what those differences were and what they meant.
Harvey Grossel, Oakland Ops, question: The Rocky Flats experience is important to this process because of their hygiene practices. There may be some evidence that LPT positives can be generated by skin contamination. What kind of general hygienic procedures did you see at Rocky Flats in the Be area?
Nohava: In general, areas were kept clean. When you see people machining metal, there’s chips and dust and that sort of thing. But the floors were kept clean, in terms of safety. Rocky Flats was a lot cleaner than individuals in the community expected, especially so in most of the 700 complex. I would exclude Building 771, the old plutonium recovery building; I went in there as little as possible.
Dan Mackinow, LANL: I was assigned to the first Be disease investigation committee at Rocky Flats in 1979. George Gottrell (sp.?), with DOE-Mound, would have a copy of that report; he was chairman of that committee. It gives a good description of the RF facilities; conditions were not what we would consider the best; it could have been much better. Based on the swipe samples we took (for example, dust collected on the air return grates), exposures could have occurred. A mound of Be dust was collecting under a hole in the ventilation duct. Mike Garcia also has a copy of the report; Jim Slawski may have a copy.
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Joseph Furman, Rocky Flats: Medical Director: We are greatly concerned about the number of cases showing up. At RF, 5943 individuals have been tested; 72 cases of CBD have been identified, and an additional 126 individuals are known to be sensitized and are at risk of developing CBD. These people held a variety of jobs, from machining Be metal to clerical work. In spite of significantly differing degrees of exposure, cases of CBD have shown up in all types of jobs.
(SEE COPY OF VIEWGRAPHS)
(Tape ran out)
Question from Sikora: To what extent do you have exposure histories for these individuals?
Furman: Extremely mixed. Most is area sampling; machinists have individual sampling data. No monitoring data for secretaries and other auxiliary personnel.
Sikora: Do you have descriptions of the various job categories and what these people were doing?
Furman: Not in any great detail. Some worked in several types of jobs.
Most of those operations are no longer going on.
Nadeau question: Do you have information about how long ago these exposures occurred?
Furman: We have the data, but I’m not sure whether it’s assembled in the way you’re looking for.
Nadeau: Do you have a sense of the type of Be engineering controls used for these people?
Furman: Someone from Rocky Flats will be addressing this at the Oak Ridge meeting.
Rick Jones question: As a physician, what is your position on LPT testing?
Furman: It has an expected number of false positives (a few percent); that’s why we repeat the test, to eliminate the majority of those. There’s reason to believe that there may be a rare double false positive.
Sikora: Please describe in your written response RF’s medical surveillance program for current and former employees and your recommendations.
Nadeau: You talked about repeating the LPT to guard against a false positive reading. How many times would the LPT be done for one person?
Furman: If we get a negative result, we don’t do a second test. If we get a positive, we’ll do at least one more test, perhaps two more. If we go off-site and have the extra cost associated with travel, we sometimes will split the sample and send it to different labs so we automatically have two tests. As for false negatives, we feel we do the test often enough that we can accommodate false negatives. On our known current workers, we do the tests _______ly (annually?) at RF. That frequency fits our activity, but I wouldn’t make that recommendation for everybody.
Harvey Grossel, Oakland Ops: With asbestos, familial relationships have been shown to be important (wives, etc., have come down with the disease). Has this been documented for CBD cases for clerical and others with no documented exposure?
Furman: No.
Jerry Evans asked about excluding people who are sensitized or who smoke from further Be work.
Furman: We have had people who test negative, then have no further exposure, and then later test positive and develop CBD. There are theoretical reasons to believe that continued exposure to Be for sensitized employees would influence the course of the disease (speed up development), but we don’t have human data to back it up. National Jewish, I understand, has some data regarding smoking.
Rick Jones: Do you have a Rocky Flats policy on a worker who has been sensitized and continued exposure to Be?
Furman: We make every effort to see that that doesn’t happen. You understand that there are certain rights that the individual worker has, but in all cases, we have been able to make some accommodation for the worker. There’s no corporate policy on excluding the worker from the workplace; however, they rely on us to advise and minimize further exposure.
John Martyny, National Jewish Center: One study showed that cigarette smoking might actually be protective against Be. But, in fact, further studies have not shown any correlation one way or the other.
Furman: Smoking does interfere with the ability to test for CBD. It interferes with the ability to extract meaningful data from the lung washings.
William Mathis, University of New Mexico: Wanted more detailed data for interpreting results; need numerator data. For example, how many secretaries were tested to arrive at the numbers we have? That would give us a prevalence rate. Also, since we wouldn’t expect the disease in secretaries, it becomes critical to know what their background exposures were.
Furman: We’re attempting to collect and organize that data.
Finch comment: Both Be particles ands cigarette smoking reduce the ability of the lung to clear particles. We have observed this in our animal studies. I would raise some issue of concern for workers who have been exposed to Be and who are also smokers.
Weitzman comment: Janet __________, the DOE industrial hygienist at RF, published an article on Be exposure data a few months ago in the IH Journal.
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Dan Skoch, Vice-President for Brush Wellman: (Read a statement) Talked about importance of Be (e.g., mammograms could not be done without Be X-ray windows). Brush has almost 50 years of continuous day-to-day experience and has been involved with prevention and diagnosis of CBD.
Suggestions:
1. DOE should adopt a policy of ALARA on an expedited basis while looking at other issues.
2. DOE should focus resources on medical research that show why some are more susceptible to developing CBD.
3. A sound scientific basis for adopting new standards does not exist.
Weitzman question: Is Brush Wellman using the ALARA approach, and could you be excruciatingly explicit about how you do it?
Skoch: Yes, we do. I defer to Mark on how.
Weitzman: Does Brush believe that virtually all of the cases of CBD are likely to be the result of an overexposure, but it was an exposure that we didn’t have the ability to recognize? That the cases are probably not the result of a low exposure?
Skoch: Probably, but we have no way of knowing.
Richard Hah, LANL: What do you do with your workers who are sensitized or who have developed CBD?
Skoch: Brush Wellman provides extraordinary benefits for workers who become disabled from CBD. Our blood testing program has allowed us to find workers at a much earlier stage. As a result, we have had to adjust our policies to accommodate these individuals. We want to give as much education as we can. We give the workers several choices to make, staying at their current work, changing jobs, outplacement. We’ve even gone so far as to offer special severance and outplacement benefits to help them train to work outside the Be industry.
Hah: Do you guarantee employment for life?
Skoch: No. There’s a requirement that work is done.
Jackie Rogers question: If a person is removed from their job, do you lower pay?
Skoch: We do not lower the rate of pay because they were moved.
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Mark Kolanz, EHS Director, Brush Wellman: (Read a prepared statement). Current Be exposure standards, both occupational and environmental, are among the lowest for any element, and they have been reviewed many times. For a long time, consideration was even given to relaxing the standard. Brush Wellman is unaware of any scientific evidence that the standard is not protective. However, we do recognize that there have been sporadic reports of disease at less than 2 mg/m3. Brush Wellman has studied each of these reports and found them to be scientifically unsound. Health professionals have disputed the conclusions of those studies because, among other things, the data in these reports did not support the claimed exposure levels. DOE should be very careful when reviewing such data. Brush Wellman asks to review the data supporting DOE’s statement in the Federal Register concerning new cases of CBD occurring in workers exposed at well below the PEL for Be.
Diagnostic criteria for determining CBD changed in the 1980s with new procedures and equipment (the fiber-optic bronchoscope, new blood tests). Since the mid-1980s, individuals have been diagnosed with CBD even if they exhibit no visible symptoms, X-ray changes, or functional evidence of disease. Before the 1980s, similar workers may have gone their entire lives without discernible evidence of CBD.
Brush Wellman still believes the standard is protective, but we acknowledge the unproven possibility that, in special cases, it may not be. In light of our experience in the late 1980s and in light of new diagnostic standards, Brush Wellman is emphasizing the position that, while the 2 mg/m3 is the legal limit, prudence dictates that exposures be kept ALARA.
Lowering the standard by some arbitrary amount could create some false sense of security and divert attention from refining and improving workplace controls and investigation of the mechanisms of CBD. Recommended ALARA and continuing to work to improve work practices and procedures.
1. High-risk areas of Be work will be operated with exposures to the minimum numbers of persons necessary and to minimize over time the total number of persons experiencing this risk. High-risk areas and new construction will get priority attention for comprehensive engineering approaches to reduce or eliminate airborne Be exposure.
2. Other Be work areas and processes will have concerted continuous improvement efforts focusing on SOPs and targeted engineering improvements to reduce airborne Be exposure to ALARA.
3. Persons whose jobs do not require working with Be will have work conditions where airborne Be exposure potential has been essentially eliminated.
Brush Wellman believes medical research to be very important for eliminating chronic CBD; BW has funded the National Jewish Center to conduct independent epidemiological studies of BW’s Tucson and Elmore facilities. Recent study at the Elmore facility showed higher risk associated with ceramic production and Be pebble production. The alloy melting and casting facilities were not identified with statistically significant greater risk. This may be important because airborne measurements were comparable for the melting and casting areas and the ceramic production and pebble areas. This caused BW to question whether current air sampling methods are the best means for measuring CBD risk. BW is funding studies to determine the value of monitoring for various forms of Be (particle size, shape, solubility, chemistry, particle number, particle mass, and total BE mass).
Beryllium Industry Science Advisory Committee (BISAC), established by Brush Wellman and NGK Metals in 1990, can be important for advising DOE. Since BISAC’s inception, it has sparked interest in the scientific community. BISAC has secured about $1.5 million for Be disease research; it has directed $350,000 into six research projects dealing with the fundamentals of CBD and its detection.
Weitzman question: Asked about cases of CBD where apparently people weren’t exposed above the PEL.
Kolanz: It’s possible that these people were exposed above the PEL but we just didn’t recognize it. The opportunity for exposures above the PEL often goes undetected. I have reviewed the papers for Rocky Flats and the thing I come away with is that 15% of the samples taken were above the 2 mg/m3 level. I have enough experience to know that there are cases with people using conventional vacuums on carpets in secretarial areas where people have been tracking stuff through, and a conventional vacuum will literally blow material out into the room. We’ve taken samples where people have been sweeping in an area like that where you can get extremely high exposures for short periods of time.
Weitzman: How do you evaluate the reasonableness of lowering the exposure level vs. the cost?
Kolanz: We can’t afford to implement a full-blown ALARA program at every facility all at once, or Brush Wellman will put itself out of business. So, we are using the data we have to focus resources. We hope that improvements in air sampling will allow us to identify the important variables, such as particle size or solubility, which we can use to target efforts. BW doesn’t have an explicit model that puts the cost against the exposure level.
Jones: The deadline for submitting written comments may be negotiable.
Martyny question: Most of the data we have to date is based on average exposures. You can never exclude excursions above the standard. The difficulty is that, for most IH work, we don’t typically monitor secretaries, bystanders, etc. We need to start characterizing entire populations in a facility instead of focusing on meeting a number. Do we keep focusing on meeting or not meeting a number, or do we focus on keeping exposures ALARA?
Kolanz: Gave example of a machinist who had the exhaust ventilation for an abrasive cutting operation set up backwards. How long was the machine running this way before I spotted it? You can get an extremely high exposure in a matter of minutes. This shows how PEL can be greatly exceeded by poor practices.
Gave an example to illustrate the size of 2 mg/m3: the mass of the ink used in a typed period on a page is 4 mg.
Mark Hoover and Bob Shook, LANL: Talked about difference between ALARA and as low as reasonably practicable (ALARP). ALARP seems to have more of a connotation of cost efficiency. There are major societal benefits of using Be, and we want to preserve those.
Harvey Grossel (?): Could you describe the hygienic practices, training, and policies that BW uses?
Kolanz: It’s difficult to detail them because of personal habits and characteristics (e.g., showering procedures, wearing of jewelry); a lot of human resource sorts of issues. One practice is our locker room setup, with a clean-side/dirty-side layout with separation of personal belongings from occupational clothing. Workers need to be involved in coming up with the solution.
Sikora: Please include a description of engineering controls you use for specific operations and related cost data.
Nadeau: Please provide costs in terms of a per-worker basis if possible.
Weitzman: Would it be proper to have a dollar value on what is reasonable to reduce exposure (similar to the way the Health Physicists do for reducing rem)?
Hoover: I think we’re at the forefront of establishing a policy for balancing resources and risks to the population (balancing costs and controlling exposures). Because DOE has so many activities that cross all of these areas, we can be a leader in setting the ALARA policy.
Gene Runkel: ALARA is a good principle that was implemented many years ago and has evolved. Putting a dollar value is less important now in the rad world. We need to focus on the worker and be sure that we’re protecting them to the best of our ability. It’s very important that line managers understand and embrace this concept rather than coming up with a dollar value.
(LUNCH BREAK) ----------
Barbara Hargis, representing University of California and its three national labs: (SEE PREPARED STATEMENT) We ask that DOE clarify the necessity of having its own rule for Be in view of the fact that only a few DOE sites continue to use this metal. It’s estimated that 30,000 to 800,000 American do have the potential for exposure to Be (electronics, aerospace, etc.). Promulgation of a Be rule by DOE could have tremendous impact on other industries outside the Department. We suggest that DOE work with OSHA or ACGIH to develop a standard; or, DOE should develop a good practices guide or model program.
The University of California believes that a performance-based approach that looks at assessment of each operation, looks at potential exposure, and uses an evaluation approach that applies the best technology will provide the best protection for employees. New exposure limits are not necessary if employee exposures are minimized.
DOE should continue to invest in new technologies for control and measurement. We also suggest a prospective Be study on workers in the DOE complex.
Talked about the Cardiff experience. They reported that, on rare occasions, they have exceeded limits but in general have maintained exposures below the PEL. Using a prudent medical surveillance program, they do not have any clinically diagnosed cases of CBD to date.
The University of California can provide additional information concerning the Federal Register questions. Wipe monitoring is valuable for evaluating housekeeping and as an index of surface contamination. However, specific cleanup limits would not be effective. The University of California is also going to provide information about medical surveillance and the LPT.
Weitzman question: Please provide copies of the British studies and their policies/procedures.
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Hugh Smith, LANL: Commented on Federal Register question 25. (SEE HANDOUT)
For medical history, they have the worker fill out the American Thoracic Society questionnaire.
X-rays are reviewed by a B reader, and if abnormalities are found, the X-rays are sent to a second B reader. If we see greater than an 8% decline in pulmonary function, the individual will be sent to a pulmonologist (unless there’s other complicating influences—a cold, etc.). They ask for a CO diffusion capacity study, a testing of oxygen saturation with exercise, high resolution CT scans, and LPT as a diagnostic aid.
We can attribute LNL’s success to IH and line management efforts.
Think LPT is best used as a diagnostic aid. By applying this test to individuals who have evidence of disease, you’ve increased the potential prevalence of disease in the population, so you’re less likely to see false positives.
Currently, 246 workers are in the Be surveillance program; they receive annual medical checkups. Within the next 9 months, LANL will be using activity-based costing and then will be able to put a cost on the medical surveillance program.
Kolanz question: Asked about the denominator for the 2 people shown to have CBD in the 1970s and 1980s.
Smith: Since both of those workers had their Be exposure elsewhere, we felt that we couldn’t arrive at a denominator that fit.
Runkle: Did those two people do beryllium work at LANL?
Smith: No. They were physicists working on other projects at Los Alamos.
Jones question: How were they diagnosed?
Smith: By their primary care physician.
William Mathis, University of New Mexico, question: Have any estimates been made as to how many total workers at LANL were exposed to Be? If so, that number could be used to modify the denominator.
Smith: Dr. George Volz (sp.?) was called by Mark Eisenbud back in the early 80s to prepare a paper on the epidemiology of CBD. What Dr. Volz said was that, in that early group, there were five cases, and they were fairly certain they had 90 to 100 Be workers. (Tape ran out)
Hugh Smith’s second presentation: Addressed Question 23. (SEE HANDOUT)
We’ve reviewed the existing literature and have not found a reliable marker of susceptibility to CBD. This packet of literature on CBD is being prepared for our study center at Los Alamos; it will be available for all Be workers and others interested.
From a clinical stance, we’re not going to be in the business of prevention. We must rely on IH and line management to provide primary prevention.
There have been no cohort studies that compare the clinical outcomes for cases with early detection vs. cases with later detection. So, there’s no way to judge the effectiveness of the screening programs that are out there. We need a cohort study of Be workers to determine if early detection makes a difference in the clinical outcome.
Bayes’ Theorem--When the disease in question is of low prevalence in the population, the predictive value of a positive test will be poor. In most studies, the prevalence of CBD in a population exposed to Be ranges from 2% to 6%. I’ve used 5% as a nominal figure because that’s what we’ve seen at Los Alamos. If you had a very good screening test and a population of 2000 Be workers, you would end up with a positive predictive value of 50%. So, for every true positive, you’d have a false positive.
What’s going to be needed is a lot of follow-up on everyone who’s tested, so we can collect data on false positives and false negatives. Without that information, we can’t judge the accuracy of that screening test.
The problem with a false negative is that some people will latch on to that one result and never agree to be tested again. We’ve experienced that at Los Alamos. Also, with a negative test, a person is more prone to deny any early symptoms that might signal the disease. We’ve seen that also. With the false positives, you’re going to induce unnecessary anxiety. It’s not any kind of favor we do for someone. They might go on to have medical tests that involve bronchoscopy and anesthesia. The employee is in a position where he is not covered medically by his health plan, and workers comp in New Mexico will not do anything for the individual unless there’s a diagnosis.
We would like to see validation of the current screening tests—determining the number of false positives and false negatives. We would also like to see research into markers for determining susceptibility for CBD.
Weitzman question: I was under the impression that there was some predictive value to some of the screening tests. You seem to be saying that it has no real screening or predictive value. Even if there were a screening tool, you seem to be saying that it has no impact on the outcome.
Smith: Basically, we’re saying that we don’t have the information to say what the predictive value is. In terms of outcome, no one has published evidence that early detection or early treatment makes a difference in the progression of the disease. The screening tests today are for subclinical disease, and no one is going to use steroids until we start to see a fall-off in pulmonary function. Basically, you’re waiting until the person has become mildly symptomatic.
We can say that early detection allows for earlier treatment, but no one has published any evidence that earlier treatment influences the outcome of the disease. We’ve had individuals with such a slowly progressive case of the disease that they’ve almost not required treatment; it’s not a problem for them. Someone needs to do a cohort study; otherwise, we’re left with anecdotal evidence.
Sikora question: In light of the uncertainty of the screening test, what would you recommend be done for medical monitoring? What does LANL do right now?
Smith: What we plan to do is continue our surveillance program that’s already in place. We might be criticized that we’re not going to pick up someone until we see evidence of disease on the chest X-ray or they become symptomatic, but that would be our earliest detection of disease. But, with our experience, we can’t say that our method works any better than anybody else’s. We’ve done it empirically, based on what NIOSH recommended back in the 70s, while adding a few ingredients. We’re reluctant to add any more to our medical monitoring program until there’s good evidence that whatever we’re adding, especially if it’s expensive, is going to be effective in modifying the course of the disease.
Jones: How do you use the LPT test as a diagnostic aid? Under what protocol?
Smith: If we have any findings of pulmonary disease that could possibly include CBD, then we use LPT to separate between the various disease entities to determine what the person has. What we deal with is sarcoidosis—it’s out there in almost the same prevalence. So, when we get a case of sarcoidosis, we want all of the evaluation to make that distinction.
Furman: Defended the use of LPT when it’s done twice. Compared the use of LPT with the use of treadmill tests for nonsymptomatic cardiology subjects. At DOE, this is often used on security guards. It’s an awful test as far as predictive value in someone without chest pain or other symptoms of cardiovascular disease. But we use it because we’re putting these guards in a special circumstance. That’s the same thing we’re doing here. When you do double testing, as we do, you end up with a test that shows about half the people that have CBD who have tested double positive. That’s pretty good. For those people who don’t have CBD, it may very well be identifying those who are sensitized and may go on to develop the disease. Or, those people may be at increased risk because of further exposure. Most of our employees want to know that so they can make their own decisions about further exposures. We’ve tested thousands of people and former workers who want to know. They’re willing to accept those statistics (predictive value). We have to give employees, former and current, the opportunity to make their own decisions, using whatever technology is available.
Smith: As for the treadmill test, basically we do know the positive predictive value in an asymptomatic population (it’s 30%). At Los Alamos, the most exertional activity our guards have is when they take their annual run. If there’s going to be an adverse event associated with exercise, it’ll be at that time. Basically, to improve the positive predictive value, what we use is a screening based on coronary heart disease risk factors (age, etc.). We use a protocol developed by the American College of Sports Medicine to determine which guards will go for treadmill. When they come up with a positive value, we go to the next level of diagnosis. With the LPT, your ability to advise the employee or even put them on treatment—no one has shown that that really improves their clinical course as opposed to treating them until they are definitely symptomatic.
Furman: It’s a matter of the right to know, because it does make a difference in how the employees lead their lives. We’ve been able to explain this to employees to their satisfaction.
[Long discussion between Smith and Furman involving the pros and cons of using the LPT in view of (1) the number of false positives, (2) the apparent fact that early detection of CBD may have no bearing on treatment or final clinical outcome, and (3) continued Be exposure may have no bearing on disease development.]
Smith: Oak Ridge recently looked at the influence of the human serum used for the LPT. They found very different results for an activated serum than for a pooled human serum.
Furman: That’s exactly right. That’s probably what’s wrong with the test. We’ve found in using three labs, that the labs seem to give consistent results for one patient, where for another patient, they don’t. There are apparently factors with this serum that haven’t been worked out. There may be different sub-variants of the disease that one lab can pick up and another lab doesn’t. But if you’re using several labs, and the person is showing up positive on all of the tests, that person has a pretty good chance of being sensitized and going on to develop the disease. We’re seeing latency periods of 10, 20, even 30 years in some employees.
Dick Coble: From the data I’ve seen, X-rays are the worst predictor in the world for CBD.
Smith: If you talk to Lee Newman at National Jewish, he’ll tell you that among the standard pulmonary disease screening tests, the X-ray is where you’re going to see the first evidence of CBD. (Tape ran out) I can’t support the chest X-ray any more than I can support the LPT. Before we rush in and start using a screening test that we poorly understand, we should try to obtain more evidence that would tell us how to advise an individual if they get a positive or negative result.
Richard Castle, LANL: Do the 246 workers include subcontractors?
Smith: Also includes us (JCI employees), and that number will be growing as we get into cleanup.
Harvey Grossel: There is an indication that a positive LPT could be a transient event (e.g., caused by a soluble compound that could be cleared by the body). There’s also evidence to say that the less soluble materials caused disease more readily than the more soluble materials. Could the errors in LPT be a function of this type of variable?
Smith: A great deal of work needs to be done to standardize the LPT and to make it more reliable. We have a study protocol at LANL, and they do not use human serum for the LPT. They also use a different method of detecting proliferation (fluorescent dyes and flow cytometry(?)) to determine the change in DNA content before and after challenge with Be.
Finch: One of the papers I’ll be providing shows that beagles exposed to Be oxide exhibited transitory lymphocyte stimulation properties. However, those dogs never did go on to really constitute a true model of human CBD.
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Larry Foreman, LANL: I'm manager of a group that makes very small Be parts. I came here with the concern that we are doing the right things for the safety of our workers. I think what I heard today is that there was not compelling evidence that the PEL is set too high. I would ask you to be very deliberate and involve as many other agencies such as OSHA in your decision. Second, I am concerned about my employer. DOE-DP also has a stake in these deliberations, and I think they should be involved more formally.
Jones: What we are putting together is a team at the staff level with personnel from the HQ Program Offices, the Ops Offices, etc., to develop the program. Also putting into place an executive team (DASs and AMESHs) to be the next level above the working staff level.
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Richard Mah, LANL: He’s group leader for metallurgical engineering, which will have responsibility for the new Be facility at LANL. First, a little history. In 1993, DOE decided to move the Be operations to LANL from RF to consolidate Be operations in one area. We’ve heard a lot of debate about levels. The bottom line is that Be causes CBD. We need to minimize the number of facilities that work with Be. That way we can concentrate on developing a first-class facility. It’s just good business practice to try to operate in the safest environment possible. Our facility will have only about 30 people working in it. We’re going to put closed-circuit TV in the facility so that we will have no visitors. Therefore, exposure to visitors is zero. We’re talking about a very small cost of operating this facility, less than $12 million. Please coordinate among the various parts of DOE so that the funding agency is aware and on board and will help us reach whatever level you set.
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Corville Nohava: Has been tested under the Be program at Rocky Flats, has gotten three positives, and supports Dr. Furman’s advocacy of LPT for screening purposes. Appreciates the opportunity to be informed and be allowed to make his own decisions.
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Harvey Grasso: Comment on carcinogen issue. IARC recently reclassified Be as a human carcinogen. NIOSH came to that conclusion 20 years ago. That’s an issue that can be discussed.
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Look at Particular Federal Register Questions
Question #11: Concerning monitoring strategies
Weitzman: What’s the most appropriate air monitoring strategy for Be exposure? A strategy designed to show compliance with a certain level (probably not the direction in view of ALARA)? Another approach would be to show as typical an exposure as possible. Should DOE’s standard be explicit about sample size, statistics, etc.?
Harvey Grasso: Any monitoring that’s done has to have a good work record to go along with it. Samples collected without this description would be of little value for interpretation. Secondly, we’re not in the business of doing epidemiology, we’re in the business of protecting workers. The epidemiological work we do should be aimed at protecting workers--should be worked into performance measure systems to stimulate change and reduce exposures.
Weitzman: What would you want to see for performance measures?
Grasso: My feeling is that the performance measure would be something more like "no exposures over the Action Level" and "show a decreasing trend in exposures over time." You have to set up a written monitoring plan with written sampling goals based on known operations.
Jones: Is the Department in the position to implement lapel monitoring for all Be workers?
Rob Hadley: What we do usually is worst-case sampling. Based on our professional judgment, we will go and sample when we expect the worst levels. One of the complicating factors is that those operations at the Lab usually last less than 15 minutes. For epidemiological purposes, we don’t do it often enough. The thing that would really help is a real-time monitor. It would give us a lot of information. Now, we need to do the TWA, and we should be doing more of the STEL. We monitor the worst-case operations, and if we come up with a level that is above 2, for instance, or for a STEL above 5 or 10, we will look for engineering controls to try and get it down. We would like to get it to a level that we’re happy with before we stop doing monitoring. Then, we go back on a quarterly or annual basis to follow up. Part of this is written up in our exposure plan.
Kolanz: Please provide that a standard be general enough that the protocol can be tailored to different facilities and tasks. Even general area samplers have a value for some operations and certain checks. The IH should make that call. We still find it of value to go after exposures that appear to be non-events. We get surprised. We’ve caught samples in the past where someone clapped gloves together after performing a task, and we just happened to have a high-volume sampler there and caught a sample of 3,000 mg in close proximity. Another one where we had a fluoride extraction furnace, where the puff was in the neighborhood of 2,000 to 3,000 mg. Any standard should have a general requirement for statistical assessment of the data. One of things we’re looking to do is to have the operations people (not the IHs) do the statistical control charts and post them. Getting the data up and in front of people quickly is of value. We’re looking at requiring these charts at entrances to buildings and rooms, so people can make their own choice about whether they want to wear a respirator, whether it’s required or not.
Dick ______: Monitoring should be both operator- and process-specific. The operator should be qualified at an operation because different operators can generate different amounts of aerosols. Until you are qualified, you would need more detailed sampling.
Finch (I think?): If we try to do compliance monitoring (to a certain level), then we will never answer the questions about what people are being exposed to. It’s really important to look at all jobs and each individual and do that sampling enough to develop a certain level of confidence. We believe in personal lapel-type samplers. We’ve done about 1400 filters in this last project looking at specific jobs. What we’re finding out is that there is a fairly decent variation, so you need to sample several times. It may change with alloys or with people. It takes an industrial hygienist to be there looking at what’s going on. A lot of us are starting to look at particle size. We’re finding that a substantial amount of particle aerosols generated by machining operations do produce a fair amount of particles less than 0.6 microns in diameter (over 25% of the aerosol generated). This is the size that could achieve deep penetration into the lungs. One other comment: we use wipe samples a lot to look for excursions we didn’t know about. But what do these wipes really mean? What does it mean if a machine has 1000 mg/ft2 as opposed to 25 mg/ft2? In some areas where we’ve had high readings from wipe samples, we’ve never had a hit from air monitoring. There ought to be a better way to find out how much of that 1000 mg could get airborne. DOE should look at alternatives for wet and dry wipe sampling (e.g., vacuum sampling). It’s reasonable to have a program with wipe sampling and lapel sampling. We’ve been surprised by some operations that we thought were going to be very low (EDM). It’s difficult to predict exposures. As an IH, I would want to know what to expect for exposure for everybody in my facility.
Jones: How would you keep that data in a manner that would allow you, when an individual develops CBD, to relate the data to the disease? (Also asked for copies of data sheet examples.)
Finch: A lot of the databases get so complicated that it takes a long time to enter the data. We use a fairly simple database with a comment section where we can note use of PPE, etc.
(Tape ran out)
The cost of monitoring is for the people to hang the pumps, etc. (Discussion concerning why IH costs are considered overhead and not operational costs.)
At Los Alamos, we’ve gotten our machinists involved in calibrating and hanging their own pumps. This helps minimize the expense. For our operation, it works out quite well. The machinists bring anything unusual to our attention. They’re only allowed to do this after years of data have been collected by our IHs.
Nadeau: Asked about the training for these machinists, how long it would take, costs involved, etc.
Mah: If you work with DP to go after ALARA, I think zero levels are achievable. I’m not talking about general industry. I’m just talking about us. I think we can go for zero exposure. It’s important for DOE to do that anyway. We’re going to be working with many more toxic materials. Tell us it’s ALARA and believe that we’re responsible people. Give us the funds to do this and we will do this.
Catherine Creek: I want to challenge DOE to realize what is their purpose for sampling: for epidemiology or for compliance? I think some funding should be put into a monitoring program for a prospective epidemiological study so that we know we’re collecting the right data. As far as sample costs, $12 a sample is really cheap. I’ve seen as much as $100 a sample.
Dan Mackinow, LANL: You were talking about performance measures. I would prefer that we look at, if you do find something, what actions do you take to remedy that? Performance standards should be: what are you doing to identify your exposures, and what do you do to correct it—not what was the level you found.
Real-time monitor has some limitations: large size of the monitor, problems in calibration, dependence on particle size, effects of particle deposition in sampler tubing. It’s needed, but currently there are some limitations. I hope you don’t require it as part of your standard.
Bob Shook: Employees doing the work would like to see real-time monitoring developed. Any sampling being done today is after the fact. The lag time between the exposure and the results is a concern.
Harvey Grasso: A little bird told me that a real-time monitor has already been developed by an Eastern European country.
Gene Runkel: One of the confounding issues with putting monitoring levels in the standard is the use of PPE. As you have excursions above the PEL, the effectiveness of the respirator has a lot of uncertainty in it. It’s another area that needs work.
Weitzman: The approach that OSHA takes is that the level is reported without regard to respiratory protection.
Catherine Creek: When we give numbers, we report it to the employee both ways--actual levels and with the respiratory protection factor.
Runkel: What we’ve done in Appendix F at Los Alamos is we’ve taken into account those protection factors as we’ve done evaluations. We’re really looking at protection of the employee.
Kolanz: We need to make sure that the values are readily recognizable as to whether they take PPE into account or not. At the Cardiff facilities, they made a practice of not sampling the people wearing respirators. Whether or not we agree with these strategies, we need to be clear on what has been done.
Harvey Grasso: The bottom line in terms of liability is that, within the Federal system, if the worker is in an environment where there is airborne exposure, whether or not they wear respirators, if they get the disease, you’re liable. So, the long-term goal should be to eliminate the need for respirators.
Don Harvey: If OSHA ever gets jurisdiction within DOE and sees an overexposure, whether or not there is respiratory protection, they’re going to evaluate your controls, and if your controls are not sufficient, you’re going to get a citation.
THURSDAY, JANUARY 16
Topic: Monitoring Strategies
Weitzman: I got the impression yesterday that the consensus was that two simultaneous strategies are appropriate: one to make sure your job is under control (looking at worst cases) and one to understand what are the typical exposures so we can correlate health events with actual exposures.
Mark Hoover: A third aspect of monitoring concerns respiratory protection with totally encapsulating suits. In D&D situations, you will have this because of extremely high levels in the air (10,000 times the PEL). We don’t have an effective way of sampling inside the suit. You might do a nasal swipe after they come out. It would be useful to have a suit that has a filter inside. Some of the considerations have been that the belt and the pump are extra protrusions and extra weight--added stress. I think it would be possible to take the compressed air already going to the suit and run a small pneumatic pump which would have no moving parts which would pull air through the filter. The worker almost wouldn’t even know he was being monitored. This would also have applications for plutonium. It wouldn’t be real-time, but within a day or two you would know what the exposure is. For highly contaminated jobs, this might be routine enough to be cost effective. Obviously, we’d like to do the research work.
Catherine Creek: About prospective study, 100% monitoring is required for epidemiological studies. Area monitoring is to figure out where your concerns are, to locate the hazard. It’s important that we know task and subtask for the employee. At Los Alamos, we will have the individuals who are doing the work hanging their own pumps. Also, a database will be set up with computer access all over the facility. We feel we need to keep respiratory protection samples separate. We’ll know exposure with and without respirator. It’s also important to determine particle size (we use midget impingers, cascade impactors). Impingers will be hung in the breathing zone. This is in addition to any personal BZ samples. For epidemiological purposes, we want to know about excursions. We’ll probably use a variety of methods, with sample times depending on the operation. If an operation lasts 30 minutes and exposure levels are expected to be high, we might pull 10-minute samples at a real high volume. Those will be in addition to the 8-hour TWA. You need to be careful when pulling a STEL not to compromise the TWA sample. We hope to collect enough information to determine the variability of exposures for operations and individuals. My main concern is, if we really want to find out what exposure levels cause CBD, we need to do a prospective study. At LANL, people are moving into and out of Be operations. Three IHs are now working with Be where they didn’t before. We’re trying to set up our sampling in a way that can be used for epidemiology, but it’s difficult when we have to fight for funding. This study is not written up yet; it will be documented in the Field Operations Manual for our technicians in 4 or 5 months. We probably will have 30 full-time employees in the database and about that many more transients. It’s going to be fairly expensive. We can provide cost estimates for the additional sampling, database, etc. Some area sampling will be used to determine particle size.
Mark Hoover and John Martyny wanted to do some microscopy particle analysis, but it’s not easy.
Mah: A scanning OJ in an ultra-high vacuum system can determine what the different elements are in a sample; it can spot Be pretty easily.
Nadeau question: Asked about cost/benefit ratio of putting a sampling filter inside a respirator suit. (Tape ran out)
Hoover: I think it will be cost effective. This is a small portion of our activities. It’s just a matter of being able to collect an appropriate sample. We would be focusing on one of the activities that could cause the highest exposures.
Weitzman: Can you conceive of an approach for the DOE-wide program to encourage a certain amount of monitoring that would be reasonable to ask for and still be valuable for prospective epidemiology? For example, if we requested lapel samples for total Be exposure for workers across the Department, would that be reasonable?
Jones: This has always been an issue for the Department. What’s the minimum data set that makes sense for DOE to request of the contractors so that we can collect greater than individual site data and not mix apples, oranges, and tangerines? What would you consider a minimum data set that you would be willing to collect and provide?
Kolanz: I wouldn’t be so concerned about the minimum data set, but the methodologies among the sites need to be compatible. At Brush Wellman, we have a database with many variables. We had inconsistencies among our own facilities in ways that people were taking samples. My concern was not so much the frequency, but some uniformity in the method. It doesn’t have to be exactly the same so long as results can be compared among sites. The sampling strategy needs to be left up to the individual site. A single database for all DOE Be sites could streamline the flow of information. We developed a sampling manual when we did training; I will send a copy of the pertinent parts. As for consolidation of Be tasks to as few sites as possible, I agree. DOE should know where all of the material is being used, by whom, and for what.
John Martyny, National Jewish Center: It’s imperative that DOE look at all its sites. If you look only at the 60 people at LANL, by the time you break them down into various subgroups, you don’t have much epidemiological power. What you need is numbers--a DOE-wide study like Catherine’s.
Weitzman: Asked Mike Garcia, from the Be Monitoring Subcommittee, about how receptive the various sites would be to being asked for uniform sampling and reporting procedures for epidemiological purposes.
Garcia: A consistent sampling strategy would be helpful. The dilemma is that you have such a small population of potentially exposed employees.
Jones: It would be great if we could do this across DOE and then relate it to the information from the National Jewish study and Brush Wellman data to get a national study.
Harvey Grasso: In developing a monitoring strategy, it’s important to catalog and characterize every operation in detail and then control that operation. Once you’ve established control, you use monitoring (of whatever type) to track the effectiveness of controls. As an IH, it's important to focus on this.
Catherine Creek: The best approach would be to have a consensus type of group decide what types of data need to be collected and how, what fields should be in the database. You might be collecting the data you think you want but it might not be exactly what you need.
Weitzman: The Be Subcommittee could work out the data requirements. But what success would they then have in convincing the site managers of the importance of doing this?
Mah: My management would support that. I’m faced with that situation right now. A real-life example: I’ve taken over a facility where I was told that very little Be operations have been going on there. I went out and collected the history of this building and found out that Be work was done in about 18 areas of that building. Nobody really knows what the Be situation is now. So, now, I’ve started baselining the building (160,000 ft2). They have taken about 75 samples a day at $100 a sample; $7,500 for 20% of the building. The costs are mounting. From a line management standpoint, we will do this. But, how will be pay for it? I’m hoping that I’ve got enough to stand on that my management will back me up. My IHs told me how to baseline the building.
Weitzman: Most of us don’t have to make the hard decisions about tradeoffs in spending money. How do you think that the return on the investment for safety will fall out?
Mah: How important is Be? It’s in all the nuclear weapons. We cannot abandon Be. Someone has to support that. My philosophy is that, when it comes to safety, there are no "maybes". I think the costs aren’t that significant. The issue is, when you compare it to other things in DOE, this is a drop in the bucket. You wouldn’t blink an eye at spending a billion and a half on a plutonium facility.
Jones: Would you feel more comfortable if DOE provided more guidance on what a sampling program needs to look like?
Mah: Yes.
Hoover: Safety isn’t black and white. We’re dealing with probabilities. It’s worth making the effort even if the number of Be workers is small.
Mah: I want to have a facility that I feel my kids can go into and work.
Catherine Creek: It’s a good idea to consolidate the epidemiological study throughout DOE. It’s more difficult with more players are involved. The idea of a national database scares me a little bit. When you don’t enter the data yourself, you lose a little bit of the information. People collect data differently from one facility to another and enter it differently. We need to be careful if we make this a requirement. It’s also different if you handle it as a funded study rather than as a compliance effort.
Mark Kolanz: The way we handle it is each facility runs its own database; but, it’s a universal database that I can access. We tried to make the database as broad as possible. Not everybody is going to enter everything, but the database can handle whatever they want to enter. If anyone wants to change the database, it has to be approved through corporate. There was some struggle in getting this uniform system in place throughout Brush Wellman. We were able to sort out most problems in a timely fashion.
NEW TOPIC: Concerns about medical screening test
Jackie Rogers: Who pays for these tests? Does the employee ever have to pay anything personally?
Creek: The employee never has to pay. However, in one case, one individual who wanted a particular test paid for it himself.
Mike Garcia: The dilemma is, if it’s a documented work-related condition, then workers comp will pay. However, if it’s a personal issue (not covered under workers comp), the personal insurance carrier pays. At Los Alamos, DOE is picking up the cost for screening for 350 workers. Follow-on testing would be picked up by the Laboratory after a positive determination is made.
Kolanz: No Brush Wellman employees ever incur the cost for screening tests. If they are diagnosed with CBD, they get workers comp. Also, Brush Wellman employees get a supplement to workers comp to make up the difference in the salary if they are unable to work.
Creek: At our facility, the University of California has taken the stance that it’s a study and it’s not a part of medical surveillance. Of course, if they turn out positive, they’ll be tested further. Hugh Smith should be asked about who will fund that.
Alex Romero, JCI, prime sub for LANL: JCI incurs cost for the medical surveillance. Our employees do not pay.
Nohava: It makes a difference if the worker is Federal or contractor as to who pays. (Tape ran out)
Mah: A future issue will be keeping good people working in the Be area. For that reason, you should have a policy that is at least as good as what the rest of industry does.
Dan Mackinow, LANL: There’s a lot of pressure on all overhead areas to drive overhead costs down, including ES&H. It’s easy to say we’ll fund a little more IH for Be, but every little bit adds up. In my area, we make decisions every day where to put the resources. Things like extra documentation often don’t get done unless you have a rich program. If DOE’s paying for the Be surveillance up front, it’ll get done. We can’t take on more without someone to pay the bill.
New Topic: Question #3 Concerning Action Levels
Rogers: When we did two Be surveys, we received a lot of feedback in the area of Action Levels. What levels are you currently using, and what does this Action Level trigger?
Gary Whitner, LANL: We don’t have a specific Action Level. But we will take action if we see anything above some low level that we’re uncomfortable with. Typically, 60% of our samples come back at less than the detection limit (0.01 mg/filter or 0.02 mg/m3 for a TWA). Typically, if I see anything above 0.05, I get concerned. Anything above 0.09 means reevaluating the system (ventilation, etc.) and reviewing the operation with the worker. For our area swipe samples, we have different levels for different operational areas. For a Be operations area, if we’re above 25 mg/ft2, then we need to take some cleanup operations and we initiate an investigation. For a nonaccessible Be operation, we have a higher action level of 250 mg/ft2; if that is exceeded, it triggers some actions. For non-Be operations, we have an Action Level of 2 mg/ft2. A lot of decisions have to be performance-based, depending on the specific operation. We’ll include these levels in our written comments.
Jones: Do your Action Levels take into account particle size and, for example, whether the surface where the wipe sample is taken is sticky or smooth?
Whitner: Our Action Levels are based on the IH’s professional judgment about what we can reasonably measure and attain.
Sikora: At what levels do workers go into the medical surveillance program?
Whitner: Any Be worker goes into the medical surveillance program. Examination frequencies are not based on exposure levels, but if we found a particularly high exposure for a person, we’d send them to medical.
Rogers: Does Brush Wellman use an action level to trigger anything?
Kolanz: No, we don’t use a sample-based action level. We’re based on a historical approach. At the Elmore facility, everybody participates in the medical surveillance program, no matter what their job is. We allow each facility to set its own target or response levels. At Elmore, any level above 1 mg/m3 requires investigation by the line manager. Supervisors only have a certain level of tolerance for paperwork; they’d rather lower the exposure than do the paperwork. Supervisor investigation reports are in the computer, and we can and do go back to follow up.
Weitzman: Do Brush Wellman supervisors get beat over the head when they have these excursion levels? In other words, are there disincentives for reporting excursions?
Kolanz: We have had supervisors that take things so to heart that they are unrelenting in sampling and working toward low numbers. If supervisors have bought in, it makes all the difference in the world.
Sikora: What did supervisors do to reduce exposures?
Kolanz: Lots of things, I couldn’t even begin to count them all. Simple hood modifications; eliminating steps in an operation; we’ve redesigned whole ventilation systems; slot ventilation where we’re pulling 8000 cfm through a 30-inch opening.
Rick Jones: Do you have a Lessons Learned type of program?
Kolanz: Not really, because our sites are so different. At our twice-a-year meeting, we share this type of information.
Mah: A real-life example of Action Levels. A new laboratory was being established in the basement of our facility. We took swipe samples before we moved in; they results were above the limit--it triggered the baselining of the building.
Kolanz: One word of caution: there is an ambient level of naturally occurring Be. We found 11 mg in a newspaper box in downtown Cleveland.
Creek: There’s a lot of variability in how swipes are collected and what limits are used to trigger action. Since it’s mainly used for housekeeping, I don’t think it should be addressed in a standard.
New Topic: WORK PRACTICE CONTROLS. Question #18
Sikora: Yesterday we talked about engineering controls. Now, we’d like to hear about work practice controls and how effective they’ve been.
Steve Ablen, project leader for new facility at LANL: We’ve incorporated a lot of engineering controls, centering around the HVAC system. We told the facility designers we wanted this to be as clean as an operating room; 20 air changes every hour. All equipment that generates a particulate will have some type of enclosure with two types of ventilation: low-volume for negative pressure and high-velocity to pick up the particulates. It’s a direct-digital-control, state-of-the-art ventilation system. Monitors are located throughout the ductwork. Air flow is always from least hazardous to most hazardous. I’m excited about the real-time monitor that provides direct feedback to the worker. When that alarm goes off, you know when you’ve done something wrong to cause the levels to go up. It doesn’t boil down to what number you put on us. It boils down to what the worker is doing--does he take safety seriously? I feel you’ll be able to walk through our facility and get zero exposure. Another comment: I worked at Rocky Flats before I went to Los Alamos. I’ve seen nothing but drastic improvements throughout the Be industry and throughout DOE. You’ve got people who are very concerned; we’re making great strides.
Jones: Does your design rely on any worker controls?
Ablen: The key to a good program is having a good industrial hygienist. You’ve got to have the industrial hygienist out in the field. If the worker works with the industrial hygienist long enough, he picks up information.
Jones: What kind of Be training program have you had or would you recommend?
Ablen: At Rocky Flats, we had annual computer-based training. But the best training is hands-on with an IH. We fully intend to require respirators for every operation until we develop a baseline.
Sikora: Will the real-time monitor be in full-time use?
Ablen: Eventually. Right now, I see them being used as you’re bringing up an operation to identify trouble spots.
Sikora: In the design of the facility, were health and safety controls costed separately?
Ablen: That would be fairly easy to do. We didn’t break it out as we were designing the building. We’ve been tweaking the design. We just had to go to DOE because we were $2 million over budget.
Sikora: What type of operations are in this facility?
Ablen: Everything—welding, machining, brazing, coating, powder production, plasma spray, metallography, NDT. Two-thirds will support production; one-third will support basic R&D.
Alex Romero, Johnson Controls: As for engineering controls, we did a cleanup job in one facility, and we treated the Be like you would treat asbestos—containment, negative pressure, air locks, showers, a lot of sampling. Traditionally, JCI enters LANL facilities where controls already exist. For this instance, in the Health and Safety Plan (HASP), we had to designate areas, build containment. We assigned a site safety officer and an IH there half-time to full-time. We rely on the Laboratory for training. In addition, our IH provided Be site-specific training.
Weitzman: Are all these described in the HASP? Please provide.
Mike Garcia: I want to recognize a success story at Rocky Flats. Prior to 1984, it seemed that separate organizations were working on various Be problems at RF. The incident in 1984 helped focus resources and resulted in integration of line management, medical, IH, engineering, etc. It took a team effort to resolve the problem. A disconcerting view is that there are other contractors out there who aren’t taking this integrated team approach.
Jones: That’s exactly it, and how can we at Headquarters foster this? What are the benchmarks to help people?
NEW TOPIC: WHO IS A BERYLLIUM WORKER?
Rick Jones: How are they defined, and who decides what programs that individual should be engaged in? Does the facility manager make that decision? Does the industrial hygienist get involved? What are the dynamics of the decision process?
Mah: The biggest problem we have is identifying Be workers. I would say that, up until now, everyone who has ever worked in this building or entered this building is a Be worker. I would err on the safe side--because of the experiences at Rocky Flats, anyone who enters the building should be a Be worker. In the long run, that’s going to pay off for us. (Tape ran out)
Weitzman: What about Los Alamos paying for medical screening for a subcontractor HVAC maintenance person?
Mah: Yes. That’s going to be a problem.
________: You’re going to have two classes of Be workers, monitored at different levels.
Gary Whiten, LANL: We have a formal definition of Be worker in our AR: "an employee who routinely works more than 30 days per year with beryllium that could become aerosolized and enter the work environment or an employee involved with nonroutine and routine beryllium operations where airborne concentrations of beryllium are greater than 0.5 mg/m3. Janitorial personnel in the beryllium areas are included in the beryllium worker category." We will also include maintenance workers who routinely enter the area. Most of the routine maintenance is done by JCI workers, and they are fully involved in the medical program. Anyone coming in from outside is fully trained, and other steps are taken to protect them: cleanup, PPE, restrictions on operations in the immediate vicinity. In the Be machine shop, we write up a Special Work Permit for nonroutine work. When we send in electricians to run wires for machines, we require full coveralls and full-face respirators. When they’re working on the walls, they might disturb some Be that has accumulated over the years.
Mark Hoover: We may need more than a single definition because of graded exposures. Visitors should be another class. We could work on a set of standard terms that could be acceptable to every site. Possibly as many as 5 levels, using a risk-based approach. At ITRI, at Lovelace, we have no Be workers. None of us have had area monitor readings above about a tenth of the PEL.
Jones: The problem with Be is that profiles don’t exist for what a "safe" level is. We have animal studies, but they don’t really relate to human exposures.
Hoover: One area where we could do some study is in the area of smoking combined with Be exposure. The combination of plutonium and smoking is extremely synergistic; we don’t know about Be.
Grasso?: My feeling is that a Be worker is anyone who entered a Be area where there were active Be operations generating airborne Be and we cannot document that their exposure was below an exposure limit.
NEXT TOPIC: CARCINOGENICITY OF BERYLLIUM
Jones: Is it an issue?
Kolanz: You could spend the rest of the week on this topic. Existing assessments don’t have a place in any DOE rulemaking because they’re pretty much an anomaly of the past. ACGIH recently concluded that the risk was associated with past time periods when exposures were levels of magnitude higher than today. I think the NIOSH investigator (Eisenbud?) found no increased risk after the 1960s. The research also had a lot of confounding factors (World War II workforce, steel mill workers, high sulfuric acid concentrations, smoking). A paper will be published on that in the next couple of months. Research done to date has been limited because of confounders.
Weitzman: Does anyone here have a notion of what different kinds of controls would be applied if Be were a carcinogen?
Hoover: Taking the ALARA approach is consistent with the controls used for other carcinogens.
NEW TOPIC: TRAINING AND COMMUNICATIONS PROGRAMS
Jones: What’s in place today?
Weitzman: Please include this information in any written submittals.
Steven Ablen: One of the problems at Rocky Flats was that, when sampling was done, a week or two later numbers would come back, but you had trouble remembering what it was all about. Now, we want to give workers their results the next day. It’ll be full disclosure. The doctors review all of the data with the workers, show them the X-rays, etc.
Jones: Do you roll these numbers up and publish an annual report that the employee signs? I’m thinking about 30 years down the road, when a worker comes back and sues you, making all kinds of accusations.
Ablen: If you’ve got a good IH program, you can trend the results. You go over it every month, and the worker gets educated. It’s not a published number that’s going to make the workers safer.
Creek: We intend to post results every day. We’ll get permission from employees to post this personal type information on the bulletin board. We will provide employees results on a routine basis. Prior to their physical exam, we’ll print out a list of their exposures.
The Administrative Requirement for LANL (AR 6-7) states that the Industrial Hygiene group provides monitoring results to line managers. Line managers must provide results in writing to workers. Supervisors must provide initial and periodic training to identified Be workers. Training covers adverse symptoms of Be overexposure, maintenance procedures, housekeeping, appropriate emergency procedures, use of PPE, etc.
Bob Shook, LANL: When the IH runs the report and it goes to the line manager, a sanitized version (without names) also goes to be posted on the bulletin board. We’ve done Be awareness sessions with the non-Be folks who work across the hall.
Creek: Clarification: LANL will not be doing an epidemiological study of Los Alamos. We are collecting information that would be consistent for use in such a study, but doing such a study would be against Department policy. We’re doing what we feel is good IH practice. We’re collecting the data but not doing an epidemiological study.
Question: How many Be D&D sites are there? Informal survey showed three (LANL, RF, and Y-12).
Mark Hoover: We’ve done a Be literature search of 2500 references; we’ll be adding a few others and will send you an updated copy. It’s on the Livermore home page. As part of the DOE Be initiative, it would be nice if this literature could be scanned in and made available on the web.
MEETING ADJOURNED