Corticosteroid therapy, in workers whose beryllium exposure has ceased, has been shown to control inflammation, ease symptoms, and in some cases prevent the development of fibrosis.  However, corticosteroid use can have adverse effects, including increased risk of infections; accelerated bone loss or osteoporosis; psychiatric effects such as depression, sleep disturbances, and psychosis; adrenal suppression; ocular effects; glucose intolerance; excessive weight gain; increased risk of cardiovascular disease; and poor wound healing.  The effects of CBD, and the common treatments for CBD, are discussed in detail in the preamble at Section V, Health Effects, and Section VIII, Significance of Risk.
      OSHA's review of the literature on CBD suggests three broad types of CBD progression (see the preamble to the proposed standard at Section V, Health Effects).  In the first, individuals progress relatively directly toward death related to CBD.  They suffer rapidly advancing disability and their death is significantly premature.  Medical intervention is not applied, or if it is, does little to slow the progression of disease.  In the second type, individuals live with CBD for an extended period of time.  The progression of CBD in these individuals is naturally slow, or may be medically stabilized. They may suffer significant disability, in terms of loss of lung function -- and quality of life -- and require medical oversight their remaining years.  They would be expected to lose some years of normal lifespan -- see discussion below.  As discussed previously, advanced CBD can involve organs and systems beyond the respiratory system; thus, CBD can contribute to premature death from other causes.  Finally, individuals with the third type of CBD progression do not die prematurely from causes related to CBD.  The disease is stabilized and may never progress to a debilitating state. These individuals nevertheless may experience some disability or loss of lung function, as well as side effects from medical treatment, and may be affected by the disease in many areas of their lives: work, recreation, family, etc.
      In the analysis that follows, OSHA assumes, based on the clinical experience discussed below, that 35 percent of workers who develop CBD experience the third type of progression and do not die prematurely from CBD.  The remaining 65 percent were estimated to die prematurely, whether from rapid disease progression (type 1) or slow (type 2).  Although the proportion of CBD patients who die prematurely as a result of the disease is not well understood or documented at this time, OSHA believes this assumption is consistent with the information submitted in response to the RFI.  Newman et al. (2003) presented a scenario for what they considered to be the "typical" CBD patient:
      We have included an example of a life care plan for a typical clinical case of CBD. In
      this example, the hypothetical case is diagnosed at age 40 and assumed to live an
      additional 33.7 years (approximately 5% reduced life expectancy in this model).  In this hypothetical example, this individual would be considered to have moderate severity of chronic beryllium disease at the time of initial diagnosis. They require treatment with prednisone and treatment for early cor pulmonale secondary to CBD. They have experienced some, but not all, of the side effects of treatment and only the most common CBD-related health effects.

In short, most workers diagnosed with CBD are expected to have shortened life expectancy, even if they do not progress rapidly and directly to death.  It should be emphasized that this represents the Agency's best estimate of the mortality related to CBD based upon the current available evidence.  As described here and in Section V, Health Effects, there is a substantial degree of uncertainty as to the prognosis for those contracting CBD, particularly as the relatively less severe cases are likely not to be studied closely for the remainder of their lives.
	As mentioned previously, OSHA used the Cullman data set for empirical estimates of beryllium sensitization and CBD prevalence in its exposure response model, which translates beryllium exposure to risk of adverse health endpoints for the purpose of determining the benefits that could be achieved by preventing those adverse health endpoint .
	OSHA chose the cumulative exposure quartile data as the basis for this benefits analysis.  The choice of cumulative quartiles was based in part on the need to use the cumulative exposure forecast developed in the model, and in part on the fact that in statistically fitted models for CBD, the cumulative exposure tended to fit the CBD data better than other exposure variables.   OSHA also chose the quartile model because the outside expert who examined the logistic and proportional hazards models believed statistical modeling of the data set to be unreliable due to its small size.  In addition, the proportional hazards model with its dummy variables by year of detection is difficult to interpret for purposes of this section.  Of course regression analyses are often useful in empirical analysis.  They can be a useful compact representation of a set of data, allow investigations of various variable interactions and possible causal relationships, have added flexibility due to covariate transformations, and under certain conditions can be shown to be statistically "optimal."   However, they are only useful when used in the proper setting.  The possibility of misspecification of functional form, endogeneity, or incorrect distributional assumptions are just three reasons to be cautious about using regression analyses.
      On the other hand, the use of results produced by a quartile analysis as inputs in a benefits assessment implies that the analytic results are being interpreted as evidence of an exposure-response causal relationship.  Regression analysis is a more sophisticated approach to estimating causal relationships (or even correlations) than quartile or other quantile analysis, and any data limitations that may apply to a particular regression-based exposure-response estimation also apply to exposure-response estimation conducted with a quartile analysis using the same data set.  In this case, OSHA adopted the quartile analysis because the logistic regression analysis yielded extremely high prevalence rates for higher level of exposure over long time periods that some might not find credible.  Use of the quartile analysis serves to show that there are significant benefits even without using an extremely high estimate of prevalence for long periods of exposure at high levels.  As a check on the quartile model, the Agency performed the same benefits calculation using the logit model estimated by the Agency's outside expert, and these benefit results are presented in a separate OSHA background document (OSHA, 2015b).  The difference in benefits between the two models is slight, and there is no qualitative change in final outcomes.  The Agency solicits comment on these issues.
      To examine the effect of simply changing the PEL, including the effect of the standard on  some dental labs to discontinue their use of beryllium, OSHA compared the number of CBD-related deaths (mortality) and cases of non-fatal CBD (morbidity) that would occur if workers were exposed for a working life to PELs of 0.1, 0.2, or 0.5 μg/m[3] to the number of cases that would occur at current levels of exposure at or below the current PEL.  The number of avoided cases over a hypothetical working life of exposure for the current population at a lower PEL is then equal to the difference between the number of cases at levels of exposure at or below the current PEL for that population minus the number of cases at the lower PEL.  This approach represents a steady-state comparison based on what would hypothetically happen to workers who received a specific average level of occupational exposure to beryllium during an entire working life.  Later in this chapter, OSHA modifies this approach by introducing a model that takes into account the timing of benefits before steady state is reached.
      As indicated in Table VII-1, the Agency estimates that there would be 16,240 cases of beryllium sensitization, from which there would be 11,017, or about 70 percent, progressing to CBD.  The Agency arrived at these estimates by using the CBD and BeS prevalence values from the Agency's preliminary risk analysis, the exposure profile at current exposure levels (under an assumption of full, or fixed, compliance with the existing beryllium PEL), and the model outlined in the previous methods of estimation section after a working lifetime of exposure.  Applying the prior midpoint estimate, as explained above, that 65 percent of CBD cases cause, or contribute to, premature death, the Agency predicts a total of 7,161 cases of mortality and 3,856 cases of morbidity from exposure at current levels; this translates, annually, to 165 cases of mortality and 86 cases of morbidity.  At the proposed PEL, OSHA's base model estimates that, due to the airborne factor only, a total of 2,563 CBD cases would be avoided from exposure at current levels, including 1,666 cases of mortality and 897 cases of morbidity -- or an average of 37 cases of mortality and 20 cases of morbidity annually.  OSHA has not estimated the quantitative benefits of sensitization cases avoided.
      OSHA requests comment on this analysis, including feedback on the data relied on and the approach and assumptions used.  As discussed earlier, based on information submitted in response to the RFI, the Agency estimates that most of the workers with CBD will progress to an early death, even if it comes after retirement, and has quantified those cases prevented.  However, given the evolving nature of science and medicine, the Agency invites public comment on the current state of CBD-related mortality.
      The proposed standard also includes provisions for medical surveillance and removal.  The Agency believes that to the extent the proposal provides medical surveillance sooner and to more workers than would have been the case in the absence of the proposed standard, workers will be more likely to receive appropriate treatment and, where necessary, removal from beryllium exposure.  These interventions may lessen the severity of beryllium-related illnesses, and possibly prevent premature death.  The Agency requests public comment on this issue.
CBD Cases Prevented by the Ancillary Provisions of the Proposed Standard

      The nature of the chronic beryllium disease process should be emphasized.  As discussed in the preamble to the Proposed Standard at section V, Heath Effects, the chronic beryllium disease process involves two steps.  First, workers become sensitized to beryllium.  In most epidemiological studies of CBD conducted to date, a large percentage of sensitized workers have progressed to CBD.  A certain percentage of the population has an elevated risk of this occurring, even at very low exposure levels, and sensitization can occur from dermal as well as inhalation exposure to beryllium.  For this reason, the threat of beryllium sensitization and CBD persist to a substantial degree, even at very low levels of airborne beryllium exposure.  It is therefore desirable not only to significantly reduce airborne beryllium exposure, but to avoid nearly any source of beryllium exposure, so as to prevent beryllium sensitization.
      The analysis presented above accounted only for CBD-prevention benefits associated with the proposed reduction of the PEL, from 2 ug/m[3] to 0.2 ug/m[3].  However, the proposed standard also includes a variety of ancillary provisions -- including requirements for respiratory protection, other personal protective equipment (PPE), housekeeping procedures, hygiene areas, medical surveillance, medical removal, and training -- that the Agency believes would further reduce workers' risk of disease from beryllium exposure.  These provisions were described in Chapter I of this PEA and discussed extensively in Section XVIII of the preamble, Summary and Explanation of the Proposed Standard.
      The leading manufacturer of beryllium in the U.S., Materion Corporation (Materion), has implemented programs including these types of provisions in several of its plants and has worked with NIOSH to publish peer-reviewed studies of their effectiveness in reducing workers' risk of BeS and CBD.  The Agency used the results of these studies to estimate the health benefits associated with a comprehensive standard for beryllium.
      The best available evidence on comprehensive beryllium programs comes from studies of programs introduced at Materion plants in Reading, PA; Tucson, AZ; and Elmore, OH.  These studies are discussed in detail in the preamble at Section VI, Preliminary Risk Assessment, and Section VIII, Significance of Risk.  All three facilities were in compliance with the current PEL prior to instituting comprehensive programs, and had taken steps to reduce airborne levels of beryllium below the PEL, but their medical surveillance programs continued to identify cases of BeS and CBD among their workers.  Beginning around 2000, these facilities introduced comprehensive beryllium programs that used a combination of engineering controls, dermal and respiratory PPE, and stringent housekeeping measures to reduce workers' dermal exposures and airborne exposures.  These comprehensive beryllium programs have substantially lowered the risk of BeS among workers.  At the times that studies of the programs were published, insufficient follow-up time had elapsed to report directly on the results for CBD.  However, since only sensitized workers can develop CBD, reduction of BeS risk necessarily reduces CBD risk as well.
      In the Reading, PA copper beryllium plant, full-shift airborne exposures in all jobs were reduced to a median of 0.1 ug/m[3] or below, and dermal protection was required for production-area workers, beginning in 2000-2001 (Thomas et al., 2009).  In 2002, the process with the highest exposures (with a median of 0.1 ug/m[3]) was enclosed, and workers involved in that process were required to use respiratory protection.  Among 45 workers hired after the enclosure was built and respiratory protection instituted, one was found to be sensitized (2.2 percent).  This is more than an 80 percent reduction in BeS from a previous group of 43 workers hired after 1992, 11.5 percent of whom had been sensitized by the time of testing in 2000.
      In the Tucson beryllium ceramics plant, respiratory and skin protection was instituted for all workers in production areas in 2000 (Cummings et al., 2007).  BeLPT testing in 2000-2004 showed that only 1 (1 percent) of 97 workers hired during that time period was sensitized to beryllium.  This is a 90 percent reduction from the prevalence of sensitization in a 1998 BeLPT screening, which found that six (9 percent) of 69 workers hired after 1992 were sensitized.
      In the Elmore, OH beryllium production and processing facility, all new workers were required to wear loose-fitting powered air-purifying respirators (PAPRs) in manufacturing buildings, beginning in 1999 (Bailey et al., 2010).  Skin protection became part of the protection program for new workers in 2000, and glove use was required in production areas and for handling work boots, beginning in 2001.  Bailey et al. (2010) found that 23 (8.9 percent) of 258 workers hired between 1993 and 1999, before institution of respiratory and dermal protection, were sensitized to beryllium.  The prevalence of BeS among the 290 workers who were hired after the respiratory protection and PPE measures were put in place was about 2 percent, close to an 80 percent reduction in beryllium sensitization.
	In a response to OSHA's 2002 Request for Information (RFI), Lee Newman et al. from National Jewish Medical and Research Center (NJMRC) summarized results of beryllium program effectiveness from several sources.  Said Dr. Newman (in response to Question #33, (Newman et al., 2003)):
      Q. 33.  What  are the potential impacts of reducing occupational exposures to beryllium in terms of costs of controls, costs for training, benefits from reduction in the number or severity of illnesses, effects on revenue and profit, changes in worker productivity, or any other impact measures than you can identify?

      A:  From experience in [the Tucson, AZ facility discussed above], one can infer that approximately 90% of beryllium sensitization can be eliminated. Furthermore, the preliminary data would suggest that potentially 100% of CBD can be eliminated with appropriate workplace control measures.

      In a study by Kelleher 2001, Martyny 2000, Newman, JOEM 2001 in a plant that  previously had rates of sensitization as high as 9.7%, the data suggests that when lifetime weighted average exposures were below 0.02 ug per cu meter that the rate of sensitization fell to zero and the rate of CBD fell to zero as well.

      In an unpublished study, we have been conducting serial surveillance including testing new hires in a precision machining shop that handles beryllium and beryllium alloys in the Southeast United States. At the time of the first screening with the blood BeLPT of people tested within the first year of hire, we had a rate of 6.7% (4/60) sensitization and with 50% of these individuals showing CBD at the time of initial clinical evaluation. At that time, the median exposures in the machining areas of the plant was 0.47 ug per cu meter. Subsequently, efforts were made to reduce exposures, further educate the workforce, and increase monitoring of exposure in the plant. Ongoing testing of newly hired workers within the first year of hire demonstrated an incremental decline in the rate of sensitization and in the rate of CBD. For example, at the time of most recent testing when the median airborne exposures in the machining shop were 0.13 ug per cu meter, the percentage of newly hired workers found to have beryllium sensitization or CBD was now 0% (0/55). Notably, we also saw an incremental decline in the percentage of longer term workers being detected with sensitization and disease across this time period of exposure reduction and improved hygiene practices.

      Thus, in calculating the potential economic benefit, it's reasonable to work with the assumption that with appropriate efforts to control exposures in the work place, rates of sensitization can be reduced by over 90%.

      OSHA has reviewed these papers and is in agreement with Dr. Newman's testimony.  OSHA judges Dr. Newman's estimate to be an upper bound of the effectiveness of ancillary programs and examined the results of using Dr. Newman's estimate that beryllium ancillary programs can reduce BeS by 90 percent, and potentially eliminate CBD where sensitization is reduced, because CBD can only occur where there is sensitization.  OSHA applied this 90 percent reduction factor to all cases of CBD remaining after application of the reductions due to lowering the PEL alone.  OSHA applied this reduction broadly because the proposed standard would require housekeeping and PPE related to skin exposure (18,000 of 28,000 employees will need PPE because of possible skin exposure) to apply to all or most employees likely to come in contact with beryllium and not just those with exposure above the action level.  Table VII-1 shows that there are 11,017 baseline cases of CBD and that the proposed PEL of 0.2 ug/m[3] would prevent 2,563 cases through airborne prevention alone.  The remaining number of cases of CBD is then 8,454 (11,017 minus 2,563).  If OSHA applies the full ninety percent reduction factor to account for prevention of skin exposure ("non-airborne" protections), then 7,609 (90 percent of 8,454 cases) additional cases of CBD would be prevented.
      The Agency recognizes that there are significant differences between the comprehensive programs discussed above and the proposed standard.  While the proposed standard includes many of the same elements, it is generally less stringent.  For example, the proposed standard's requirements for respiratory protection and other PPE are narrower, and many provisions of the standard apply only to workers exposed above the proposed TWA PEL or STEL.  However, many provisions, such as housekeeping and beryllium work areas, apply to all employers. To account for these differences, OSHA has provided a range of benefits estimates (shown in Table VII-1), first, assuming that there are no ancillary provisions to the standard, and, second, assuming that the comprehensive standard achieves the full 90-percent reduction in risk documented  in existing programs.  The Agency is taking the midpoint of these two numbers as its main estimate of the benefits of avoided CBD due to the ancillary provisions of the proposed standard.  The results in Table VII-1 suggest that approximately 60 percent of the beryllium sensitization cases and the CBD cases avoided would be attributable to the ancillary provisions of the standard.  OSHA solicits comment on all aspects of this approach to analyzing ancillary provisions and solicits additional data that might serve to make more accurate estimates of the effects of ancillary provisions. OSHA is interested in the extent of the effects of ancillary provisions and whether these apply to all exposed employees or only those exposed above or below a given exposure level.
Morbidity Only Cases

      As previously indicated, the Agency does not believe that all CBD cases will ultimately result in premature death.  While strong empirical data on this are currently lacking, the Agency estimates that approximately 35 percent of cases would not ultimately be fatal, but would result in some pain and suffering related to having CBD, and possible side effects from steroid treatment, as well as the dread of not knowing whether the disease will ultimately lead to premature death.  These would be described as "mild" cases of CBD relative to the others. These are the residual cases of CBD after cases with premature mortality have been counted.   However, the Agency notes that some of these residual cases could involve more severe forms of CBD where the workers would have died from CBD if they had not died from other causes first.  As indicated in Table VII-1, the Agency estimates the standard will prevent 2,228 morbidity cases not preceding death (midpoint) over 45 years, or an estimated 50 cases annually.
Lung Cancer
      In addition to the Agency's determinations with respect to the risk of chronic beryllium disease, the Agency has also preliminarily determined that chronic beryllium exposure at the current PEL can lead to a significantly elevated risk of lung cancer.  OSHA used the estimation methodology outlined at the beginning of this section.  However, unlike with chronic beryllium disease, the underlying data were based on incidence of lung cancer and thus there was no need to address the possible limitations of prevalence data.  The Agency used lifetime excess risk estimates of lung cancer mortality, presented in Table VI-20 in Section VI of the preamble, Preliminary Risk Assessment, to estimate the benefits of avoided lung cancer mortality.  The lung cancer risk estimates are derived from one of the models a recent NIOSH lung cancer study, and are based on average exposure levels. The estimates of excess lifetime risk of lung cancer were taken from the line in Table VI-20 in the risk assessment labeled PWL (piecewise log-linear) not including professional and asbestos workers.  This model avoids possible confounding from asbestos exposure and reduces the potential for confounding due to smoking, as smoking rates and beryllium exposures can be correlated via professional worker status.  Of the three estimates in the NIOSH study that excluded professional workers and those with asbestos exposure, this model was chosen because it was at the midpoint of risk results.
      As indicated previously in the context of CBD, this benefits analysis assumes that exposures currently below 0.1 μg/m[3] are equal to 0.1 μg/m[3].  While the risk assessment section does not provide data on cancer risk below 0.1 μg/m[3], this assumption may theoretically result in an overestimate of baseline cancers if in fact the risk below 0.1 μg/m3  is lower than at an exposure of 0.1 μg/m[3].  However, it would have no bearing on the incremental effects of lowering the PEL to 0.2 μg/m[3], or the alternative of a 0.1 μg/m[3] PEL.

      Combining the two major fatal health endpoints -- for lung cancer and CBD-related mortality -- OSHA estimates that the proposed PEL would prevent between 1,846 and 6,791 premature fatalities over the lifetime of the current worker population, with a midpoint estimate of 4,318 fatalities prevented.   This is the equivalent of between 41 and 151 premature fatalities avoided annually, with a midpoint estimate of 96 premature fatalities avoided annually, given a 45-year working life of exposure.
 An Alternate Assumption of Exposure History
      Note that the Agency based its estimates of reductions in the number of beryllium-related diseases over a working life of constant exposure for workers who are employed in a beryllium-exposed occupation for their entire working lives, from ages 20 to 65.  In other words, workers are assumed not to enter or exit jobs with beryllium exposure mid-career or to switch to other exposure groups during their working lives.  While the Agency is legally obligated to examine the effect of exposures from a working lifetime of exposure and set its standard accordingly, in an alternative analysis purely for informational purposes, using the same underlying risk model for CBD, the Agency examined, in Table VII-2, the effect of assuming that workers are exposed for a maximum of only 25 working years, as opposed to the 45 years assumed in the main analysis.  While all workers are assumed to have less cumulative exposure under the 25-years-of-exposure assumption, the effective exposed population over time is proportionately increased.
      A comparison of Table VII-2 to Table VII-1, reflecting exposures over a maximum of 25 working years versus over a potentially 45-year working life, shows variations in the number of estimated prevented cases by health outcome.  For chronic beryllium disease, there is a substantial increase in the number of estimated baseline and prevented cases if one assumes that the typical maximum exposure period is 25 years, as opposed to 45.  This reflects the relatively flat CBD risk function within the relevant exposure range, given varying levels of airborne beryllium exposure -- shortening the average tenure and increasing the exposed population over time translates into larger total numbers of people sensitized to beryllium. This, in turn, results in larger populations of individuals contracting CBD.  Since the lung cancer model itself is based on average, as opposed to cumulative, exposure, it is not adaptable to estimate exposures over a shorter period of time.  As a practical matter, however, over 90 percent of illness and mortality attributable to beryllium exposure in this analysis comes from CBD.
      Overall, the 45-year-maximum-working-life assumption yields smaller estimates of the number of cases of avoided fatalities and illnesses than does the maximum-25-years-of-exposure assumption.  For example, the midpoint estimates of the number of avoided fatalities and illnesses related to CBD under the proposed PEL of 0.2 μg/m[3] increases from 92 and 50, respectively, under the 45-year-maximum-working-life assumption to 147 and 79, respectively, under the 25-year-maximum-working-life assumption -- or approximately a 60 to 63 percent increase.

STEP 2 - Estimating the Stream of Benefits Over Time
      Risk assessments in the occupational environment are generally designed to estimate the risk of an occupationally related illness over the course of an individual worker's lifetime.  As demonstrated previously in this chapter, the current occupational exposure profile for a particular substance for the current cohort of workers can be matched up against the expected profile after the proposed standard takes effect, creating a "steady state" estimate of benefits.  However, in order to annualize the benefits for the period of time after the beryllium rule takes effect, it is necessary to create a timeline of benefits for an entire active workforce over that period.
      In order to estimate the benefits of the standard over time, one has to consider that workers currently being exposed to beryllium are going to vary considerably in age and past exposure level  Since the calculated health risks from beryllium exposure depend on a worker's cumulative exposure over a working lifetime, the overall benefits of the proposed standard will phase in over several decades, as the cumulative exposure gradually falls for all age groups, until those now entering the workforce reach retirement and the annual stream of beryllium-related illnesses reaches a new, significantly lowered "steady state."  That said, the near-term impact of the proposed rule estimated for those workers with similar current levels of cumulative exposure will be greater for workers who are now middle-aged or older. This conclusion follows in part from the structure of the relative risk model used for lung cancer in this analysis and the fact that the background mortality rates for lung cancer increase with age.
      In order to characterize the magnitude of benefits before the steady state is reached, OSHA created a linear phase-in model to reflect the potential timing of benefits.  Specifically, OSHA estimated that, for all non-cancer cases, while the number of cases of beryllium-related disease would gradually decline as a result of the proposed rule, they would not reach the steady-state level until 45 years had passed.  The reduction in cases estimated to occur in any given year in the future was estimated to be equal to the steady-state reduction (the number of cases in the baseline minus the number of cases in the new steady state) times the ratio of the number of years since the standard was implemented and a working life of 45 years.  Expressed mathematically:

                             Nt =  (C  -  S) x (t / 45),
where Nt is the number of non-malignant beryllium-related diseases avoided in year t; C is the current annual number of non-malignant beryllium-related diseases; S is the steady-state annual number of non-malignant beryllium-related diseases; and t represents the number of years after the proposed standard takes effect, with t  <=  45.
      In the case of lung cancer, the function representing the decline in the number of beryllium-related cases as a result of the proposed rule is similar, but there would be a 10-year lag before any reduction in cancer cases would be achieved.  Expressed mathematically, for lung cancer:
                         Lt =  (Cm  -  Sm) x ((t-10) / 45)),
where 10 <=  t  <=  55 and Lt is the number of lung cancer cases avoided in year t as a result of the proposed rule; Cm is the current annual number of beryllium-related lung cancers; and Sm is the steady-state annual number of beryllium-related lung cancers.
      This model was extended to 60 years for all the health effects previously discussed in order to incorporate the 10 year lag, in the case of lung cancer, and a maximum 45-year working life, as well as to capture some occupationally-related disease that manifests itself after retirement.   (The left-hand columns in the tables in Appendix VII-A provide estimates using this model of the stream of prevented fatalities and illnesses due to the proposed beryllium rule.)  Because the rule, if finalized, will be in effect indefinitely, stopping the benefits analysis at 60 years is arbitrary; however, the longer into the future the analysis extends, the more subject it is to uncertainty, but the greater the benefits if conditions hold constant.  An internal analysis by OSHA indicated that, both in terms of cases prevented, and even with regard to monetized benefits, particularly when lower discount rates are used, the estimated benefits of the standard are larger on an annualized basis if the analysis extends further into the future.  The Agency welcomes comment on the merit of choosing some time horizon other than the 60 years analyzed in the PEA.
      In order to compare costs to benefits, OSHA assumes that economic conditions remain constant and that annualized costs -- and the underlying costs -- will repeat for the entire 60-year time horizon used for the benefits analysis (as discussed in Chapter V of this PEA).  OSHA welcomes comments on the assumption for both the benefit and cost analysis that economic conditions remain constant for sixty years.  OSHA is particularly interested in what assumptions and time horizon should be used instead and why.
Separating the Timing of  Mortality
      In previous sections, OSHA modeled the timing and incidence of morbidity.   OSHA's benefit estimates are based on an underlying CBD-related mortality rate of 65 percent.   However, this mortality is not simultaneous with the onset of morbidity.  Although mortality from CBD has not been well studied, OSHA believes, based on discussions with experienced clinicians, that the average lag for a larger population has a range of 10 to 30 years between morbidity and mortality.  The Agency's review of Workers Compensation data related to beryllium exposure from the Office of Worker Compensation Programs (OWCP)'s Division of Energy Employees Occupational Illness Compensation is consistent with this range. .  Hence, for the purposes of this proposal, OSHA estimates that mortality occurs on average 20 years after the onset of CBD morbidity. Thus, for example, the prevented deaths that would have occurred in year 21 after the promulgation of the rule are associated with the CBD morbidity cases prevented in year 1.  OSHA requests comment on this estimate and range.
      The Agency invites comment on each of these elements of the analysis, particularly on the estimates of the expected life expectancy of a patient with CBD.

STEP 3 - monetizing the Benefits of the proposed rule
      OSHA has also provided estimates of the monetary value of the benefits associated with the proposed rule.  These estimates are for informational purposes only because OSHA cannot use benefit-cost analysis as a basis for determining the PEL for a health standard.  The Agency's methodology for monetizing benefits was based on both the relevant academic literature and on the approaches OSHA and other regulatory agencies have taken in the past for similar regulatory actions.
Placing a Monetary Value on Individual Beryllium-Related Fatalities Avoided
      To estimate the monetary value of the reductions in the number of beryllium-related fatalities, OSHA relied, as OMB recommends, on estimates developed from the willingness of affected individuals to pay to avoid a marginal increase in the risk of fatality.  While a willingness-to-pay (WTP) approach clearly has theoretical merit, it should be noted that an individual's willingness to pay to reduce the risk of fatality may tend to underestimate the total willingness to pay, which could include the willingness of others -- particularly the immediate family -- to pay to reduce that individual's risk of fatality.  For estimates using the willingness-to-pay concept, OSHA relied on existing studies of the imputed value of fatalities avoided based on the theory of compensating wage differentials in the labor market.  These studies rely on certain critical assumptions for their accuracy, particularly that workers understand the risks to which they are exposed and that workers have legitimate choices between high- and low-risk jobs.  These assumptions are far from obviously met in actual labor markets.  A number of academic studies, as summarized in Viscusi and Aldy (2003), have shown a correlation between higher job risk and higher wages, suggesting that employees demand monetary compensation in return for a greater risk of injury or fatality.  The estimated trade-off between lower wages and marginal reductions in fatal occupational risk -- that is, workers' willingness to pay for marginal reductions in such risk -- yields an imputed value of an avoided fatality:  the willingness-to-pay amount for a reduction in risk divided by the reduction in risk.
      OSHA has used this approach in many recent proposed and final rules.  (See, for example,  the preambles for the proposed and final hexavalent chromium rule (OSHA, 2004; OSHA, 2006), and the preamble for the proposed respirable crystalline silica rule (OSHA, 2013).)  This approach has been criticized for yielding results that are less than statistically robust (see, for example: (Hintermann, Alberini, and Markandya, 2010).)  A more recent WTP analysis, by Kniesner et al. (2012), of the trade-off between fatal job risks and wages, using panel data, seems to address many of the earlier econometric criticisms by controlling for measurement error, endogeneity, and heterogeneity.  In conclusion, the Agency views the WTP approach as the best available and will rely on it to monetize benefits.  OSHA welcomes comments on the use of willingness-to-pay measures and estimates based on compensating wage differentials.
      Viscusi and Aldy (2003) conducted a meta-analysis of studies in the economics literature that use a willingness-to-pay methodology to estimate the imputed value of life-saving programs and found that each fatality avoided was valued at approximately $7 million in 2000 dollars.  Using the GDP Deflator (BEA, 2010), this $7 million base number in 2000 dollars yields an estimate of $8.7 million in 2010 dollars for each fatality avoided.,

Placing a Monetary Value on Individual Beryllium-Related Diseases Avoided
      In addition to the benefits that are based on the implicit value of fatalities avoided, workers also place an implicit value on occupational injuries or illnesses avoided, which reflect their willingness to pay to avoid monetary costs (for medical expenses and lost wages) and quality-of-life losses as a result of occupational illness.  Chronic beryllium disease and lung cancer can adversely affect individuals for years, or even decades, in non-fatal cases, or before ultimately proving fatal.  Because measures of the benefits of avoiding these illnesses are rare and difficult to find, OSHA has included a range based on a variety of estimation methods.
      For both CBD and lung cancer, there is typically some permanent loss of lung function and disability, on-going medical treatments, side effects of medicines, and major impacts on one's ability to work, marry, enjoy family life, and quality of life.
      While diagnosis with CBD is evidence of material impairment of health, placing a precise monetary value on this condition is difficult, in part because the severity of symptoms may vary significantly among individuals.  For that reason, for this preliminary analysis, the Agency employed a broad range of valuation, which should encompass the range of severity these individuals may encounter.
      Using the willingness-to-pay approach, discussed in the context of the imputed value of fatalities avoided, OSHA has estimated a range in valuations (updated and reported in 2010 dollars) that runs from approximately $62,000 per case -- which reflects estimates developed by Viscusi and Aldy (2003), based on a series of studies primarily describing simple accidents -- to upwards of $5 million per case -- which reflects work developed by Magat, Viscusi, and Huber (1996) for non-fatal cancer.  The latter number is based on an approach that places a willingness-to-pay value to avoid serious illness that is calibrated relative to the value of an avoided fatality.  OSHA previously used this approach in the Preliminary Economic Analysis (PEA) supporting its respirable crystalline silica proposal (OSHA, 2013) and in the Final Economic Analysis (FEA) supporting its hexavalent chromium final rule (OSHA, 2006), and EPA (EPA, 2003) used this approach in its Stage 2 Disinfection and Disinfection Byproducts Rule concerning regulation of primary drinking water.  Based on Magat, Viscusi, and Huber (1996), EPA used studies on the willingness to pay to avoid nonfatal lymphoma and chronic bronchitis as a basis for valuing a case of nonfatal cancer at 58.3 percent of the value of a fatal cancer.  OSHA's estimate of $5 million for an avoided case of non-fatal cancer is based on this 58.3 percent figure.
      There are several indirect benchmarks for valuation of health impairment due to beryllium exposure, using a variety of techniques, which provide a number of mid-range estimates between OSHA's high and low estimates, by looking at other forms of lung impairment.  For example, EPA (2008) recently estimated a cost of approximately $460,000, in 2008 dollars, per case of chronic bronchitis, which OSHA (2009) used as the basis for comparison with less severe lung impairments from diacetyl exposure.
      Another approach is to employ a cost-of-injury model.  Combining estimates of loss of income, medical cost, and loss of quality-of-life components, Miller (2005), using an enhanced cost-of-injury model, estimated the average silicosis disease cost the equivalent of $317,000 per case, in 2009 dollars.   While different conditions, silicosis and CBD have several similarities: both are progressive diseases; both are a form of pneumoconiosis; and both cause fibrosis.  Disease progression can last decades in both cases.  Both cause debilitative conditions -- shortness of breath to loss of pulmonary function, loss of appetite, and cor pulmonale.  Miller (2005) also estimated the morbidity costs of several different pneumoconioses other than silicosis and found the other cases to be even more costly to society than silicosis.  This suggests that a more precise WTP estimate of CBD would produce an estimate well above the $62,000 estimate of injuries in (Viscusi and Aldy, 2003).  Moreover, several studies (e.g., Alberini and Krupnick, 2000) have found that the cost of injury approach tends to significantly underestimate the true economic cost of an injury or illness, relative to the willingness to pay approach, which tends to include quality of life impacts and psychic costs as well as lost income and the portion of medical costs patients themselves pay.
      Specifically, for chronic beryllium disease, an estimate of $1.45 million was proposed in 2000 to account for direct morbidity and medical costs (Bartell, et al., 2000).  The authors noted that while a willingness to pay estimate specific to CBD is not available, it would likely run substantially higher than $1.45 million.  Adjusted to 2010 dollars, the direct cost estimate would be about $1.8 million.  This appears to be generally consistent with the midpoint (between $62,000 and $5 million) willingness-to-pay estimate of $2.58 million that OSHA is using.
       Therefore, as discussed, the various studies presented in this section suggest that the imputed value of avoided morbidity associated with beryllium exposure, for cases preceding death, ranges between $62,000 and $5 million.  The Agency believes this range of estimates is descriptive of the value of preventing morbidity associated with the trauma of CBD that ultimately results in premature death.  As discussed previously, the Agency has estimated that 65 percent of CBD cases would hypothetically result in premature mortality.  However, the Agency acknowledges that it is possible there have been new developments in medicine and industrial hygiene related to the benefits of early detection, medical intervention, and greater control of exposure achieved within the past decade.  For that reason, as elsewhere, the Agency requests comment on these issues.
      Also not clear are the negative effects of the illness in terms of lost productivity, medical costs, and potential side-effects of a lifetime of immunosuppressive medication.  Nonetheless, the Agency is assigning a valuation of $62,000 per case, to reflect the WTP value of a prevented injury not estimated to precede premature mortality.  The Agency believes this is conservative, in part because, with any given case of CBD, the outcome is not known in advance, certainly not at the point of discovery; indeed much of the psychic value of preventing the cases may come from removing the threat of premature mortality.  In addition, as previously noted, some of these cases could involve relatively severe forms of CBD where the worker died of other causes; however, in those cases, the duration of the disease would be shortened.  While beryllium sensitization is a critical precursor of CBD, this preliminary analysis does not attempt to assign a separate value to sensitization itself.
      Particularly given the uncertainties in valuation on these questions, the Agency is interested in public input on the issue of valuing the cost to society of morbidity associated with CBD, both in cases preceding mortality, and those that may not result in premature mortality.  The Agency is also interested in comments on whether it is appropriate to assign a separate valuation to prevented sensitization cases in their own right, and if so, how such cases should be valued.

Summary of Monetized Benefits
      Table VII-3 presents the estimated annualized (over 60 years, using a 0 percent discount rate) benefits from each of these components of the valuation, and the range of estimates, based on uncertainty of the prevention factor (i.e., the estimated range of prevented cases, depending on how large an impact the rule has on cases beyond an airborne-only effect), and the range of uncertainty regarding valuation of morbidity.  Mid-point estimates of the undiscounted benefits for each of the first 60 years are provided in the middle columns of Table VII-A-1 in Appendix VII-A at the end of this chapter.  For the period examined, the estimates reach a peak of $3.5 billion in the 60[th] year. Note that, by using a 60-year time-period, OSHA is not including any monetized fatality benefits associated with reduced worker CBD cases originating after year 40 because the 20-year lag takes these CBD fatalities beyond the 60-year time horizon.  To this extent, OSHA will have underestimated benefits.
      As shown in Table VII-3, the full range of monetized benefits, undiscounted, for the proposed PEL of 0.2 ug/m[3] runs from $291 million annually, in the case of the lowest estimated of prevented cases of CBD, and the lowest valuation for morbidity, up to $2.1 billion annually, for the highest of both.  Note that the value of total benefits is more sensitive to the prevention factor used (ranging from $430 million to $1.6 billion, given estimates at the midpoint of the morbidity valuation) than to the valuation of morbidity (ranging from $666 million to $1.3 billion, given estimates at the midpoint of prevention factor).
      Also, the analysis illustrates that most of the morbidity benefits are related to CBD and lung cancer cases that are ultimately fatal.  At the valuation and case frequency midpoint, $653 million in benefits are related to mortality, $226 million are related to severe morbidity preceding mortality, and $4.3 million are related to "mild" cases of morbidity not preceding mortality.

Adjustment of WTP Estimates to Reflect Rising Real Income over Time
      OSHA's estimates of the monetized benefits of the proposed rule are based on the imputed value of each avoided fatality and each avoided beryllium-related disease.  As previously discussed, these, in turn, are derived from a worker's willingness to pay to avoid a fatality (with an imputed value per fatality avoided of $8.7 million in 2010 dollars) and to avoid a beryllium-related disease (with an imputed value per disease avoided of between $62,000 and $5 million in 2010 dollars).  To this point, these imputed values have been assumed to remain constant over time.   However, two related factors suggest that these values will tend to increase over time.
      First, economic theory indicates that the value of reducing life-threatening and health-threatening risks -- and correspondingly the willingness of individuals to pay to reduce these risks -- will increase as real per capita income increases.  With increased income, an individual's health and life becomes more valuable relative to other goods because, unlike most other goods, they are without close substitutes.  Expressed differently, as income increases, consumption will increase but the marginal utility of consumption will decrease.  In contrast, added years of life (in good health) is, in the model of Hall and Jones (2007), not subject to the same type of diminishing returns -- implying that an effective way to increase lifetime utility is by extending one's life and maintaining one's good health.

      Second, real per capita income has broadly been increasing throughout U.S. history, including recent periods.  For example, for the period 1950 through 2000, real per capita income grew at an average rate of 2.31 percent a year (Hall and Jones, 2007),  although real per capita income for the recent 25 year period 1983 through 2008 grew at an average rate of only 1.3 percent a year (U.S. Census Bureau, 2010).  More important is the fact that real U.S. per capita income is projected to grow significantly in future years.  For example, the Annual Energy Outlook (AEO) projections, prepared by the Energy Information Administration (EIA) in the Department of Energy (DOE), show an average annual growth rate of per capita income in the United States of 2.7 percent for the period 2011-2035.  The U.S. Environmental Protection Agency prepared its economic analysis of the Clean Air Act using the AEO projections.  OSHA believes that it is reasonable to use the same AEO projections employed by DOE and EPA, and correspondingly projects that per capita income in the United States will increase by 2.7 percent a year.
      On the basis of the predicted increase in real per capita income in the United States over time and the expected resulting increase in the value of avoided fatalities and diseases, OSHA has adjusted its estimates of the benefits of the proposed rule to reflect the anticipated increase in their value over time.  This type of adjustment has been supported by EPA's Science Advisory Board (EPA, 2000) and by EPA (2010) and Department of Transportation (2014) guidelines, and applied by EPA.  OSHA proposes to carry out this adjustment by modifying benefits in year i from [Bi] to [Bi * (1 + k)[i]], where "k" is the estimated annual increase in the magnitude of the benefits of the proposed rule.
      What remains is to estimate a value for "k" with which to increase benefits annually in response to annual increases in real per capita income., where "k" is equal to "g * (η)", "g" is the expected annual percentage increase in real per capita income, and "η" is the income elasticity of the value of a statistical life.  Probably the most direct evidence of the value of "k" comes from the work of Costa and Kahn (2003, 2004).  They estimate repeated labor market compensating wage differentials from cross-sectional hedonic regressions using census and fatality data from the Bureau of Labor Statistics for 1940, 1950, 1960, 1970, and 1980.  In addition, with the imputed income elasticity of the value of life on per capita GNP of 1.7 derived from the 1940-1980 data, they then predict the value of an avoided fatality in 1900, 1920, and 2000.  Given the change in the value of an avoided fatality over time, it is possible to estimate a value of "k" of 3.4 percent a year from 1900-2000; of 4.3 percent a year from 1940-1980; and of 2.5 percent a year from 1980-2000.
      Other, more indirect evidence comes from estimates in the economics literature of "η", the income elasticity of the value of a statistical life.  Viscusi and Aldy (2003) performed a meta-analysis on 49 wage-risk studies and concluded that the confidence interval upper bound on the income elasticity did not exceed 1.0 and that the point estimates across a variety of model specifications ranged between 0.5 and 0.6.  Applied to a long-term increase in per capita income of about 2.7 percent a year, this would suggest a value of "k" of about 1.5 percent a year.
      More recently, Kniesner, Viscusi, and Ziliak (2010), using panel data quintile regressions, developed an estimate of the overall income elasticity of the value of a statistical life of 1.44.  Applied to a long-term increase in per capita income of about 2.7 percent a year, this would suggest a value of "k" of about 3.9 percent a year.
      Based on the preceding discussion of these three approaches for estimating the annual increase in the value of the benefits of the proposed rule and the fact that the projected increase in real per capita income in the United States has flattened in recent years and could remain so, OSHA suggests a conservative value for "k" of approximately 2 percent a year.  The Agency invites comment on this estimate and on estimates of the income elasticity of the value of a statistical life.
	The Agency believes that the rising value, over time, of health benefits is a real phenomenon that should be taken into account in estimating the annualized benefits of the proposed rule.  Table VII-IV, in the following section, shows estimates of the monetized benefits of the proposed rule (under alternative discount rates) with this estimated increase in monetized benefits over time. The Agency invites comment on this adjustment to monetized benefits and has conducted a sensitivity analysis later in this chapter of the effects on the benefits and net benefits of the proposed rule in the absence of this real income adjustment.
THE Discounting Of Monetized Benefits
      As previously noted, the estimated stream of benefits arising from the proposed beryllium rule is not constant from year to year, both because of the 45-year delay after the rule takes effect until all active workers obtain reduced beryllium exposure over their entire working lives and because of, in the case of lung cancer, a 10-year latency period between reduced exposure and a reduction in the probability of disease.
Alternative Discount Rates for Annualizing Benefits
      An appropriate discount rate is needed to reflect the timing of benefits over the 60-year period after the rule takes effect and to allow conversion to an equivalent steady stream of annualized benefits. Following OMB (2003) guidelines, OSHA has estimated the annualized benefits of the proposed rule using separate discount rates of 3 percent and 7 percent.
      Consistent with the Agency's own practices in recent rulemakings, OSHA has also estimated, for benchmarking purposes, undiscounted benefits -- that is, benefits using a zero percent discount rate.
      The question remains, what is the "appropriate" or "preferred" discount rate to use to monetize health benefits?  The choice of discount rate is a controversial topic, one that has been the source of scholarly economic debate for several decades.  However, in simplest terms, the basic choices involve a social opportunity cost of capital approach or social rate of time preference approach.
      The social opportunity cost of capital approach reflects the fact that private funds spent to comply with government regulations have an opportunity cost in terms of foregone private investments that could otherwise have been made.  The relevant discount rate in this case is the pre-tax rate of return on the foregone investments (Lind, 1982a, pp. 24-32).
      The rate of time preference approach is intended to measure the tradeoff between current consumption and future consumption, or in the context of the proposed rule, between current benefits and future benefits.  The individual rate of time preference is influenced by uncertainty about the availability of the benefits at a future date and whether the individual will be alive to enjoy the delayed benefits.  By comparison, the social rate of time preference takes a broader view over a longer time horizon -- ignoring individual mortality and the riskiness of individual investments (which can be accounted for separately).
      A usual method for estimating the social rate of time preference is to calculate the post-tax real rate of return on long-term, risk-free assets, such as U.S. Treasury securities (OMB, 2003, p. 33).  A variety of studies have estimated these rates of return over time and reported them to be in the range of approximately 1 - 4 percent.
      In accordance with OMB Circular A-4 ( OMB, 2003), OSHA presents benefits and net benefits estimates using discount rates of 3 percent (representing the social rate of time preference) and 7 percent (a rate estimated using the social cost of capital approach).  The Agency is interested in any evidence, theoretical or applied, that would inform the application of discount rates to the costs and benefits of a regulation.
Summary of Annualized Benefits under Alternative Discount Rates
      Table VII-4 presents OSHA's estimates of the sum of the annualized benefits of the proposed rule, using alternative discount rates of 0, 3, and 7 percent, with the suggested adjustment for increasing monetized benefits in response to annual increases in per capita income over time.
      Given that the stream of benefits extends out 60 years, the value of future benefits is sensitive to the choice of discount rate.  As previously established in Table VII-3, the undiscounted benefits range from $291 million to $2.1 billion annually.  Using a 7 percent discount rate, the annualized benefits range from $60 million to $591 million.  As can be seen, going from undiscounted benefits to a 7 percent discount rate has the effect of cutting the annualized benefits of the proposed rule by about 74 percent.
      Tables VII-A-1 and VII-A-2, in Appendix VII-A, demonstrate how annualized benefits are derived (over the 60 years after the beryllium rule becomes effective), using the midpoint value of annualized benefits for alternate discount rates of 3 and 7 percent (with the annualized undiscounted benefits -- using a 0 percent discount rate -- derived in the middle columns of each table in Appendix VII-A).
      Taken as a whole, the Agency's best preliminary estimate of the total annualized benefits of the proposed rule -- using a 3 percent discount rate with an adjustment for the increasing value of health benefits over time -- is between $158 million and $1.2 billion, with a mid-point value of $576 million.

STEP 4 - Net Benefits of the Proposed Rule
      OSHA has estimated, in Table VII-5, the monetized and annualized net benefits of the proposed rule (with a PEL of 0.2 ug/m[3]), based on the benefits and costs previously presented in this chapter and in Chapter V of this PEA.  Table VII-5 also provides estimates of annualized net benefits for alternative PELs of 0.1 and 0.5 ug/m[3].  Both the proposed rule and the alternatives PEL options have the same ancillary provisions and an action level equal to half of the PEL in both cases.
      Table VII-5 is being provided for informational purposes only.  As previously noted, the OSH Act requires the Agency to set standards based on eliminating significant risk to the extent feasible. An alternative criterion of maximizing net (monetized) benefits may result in very different regulatory outcomes. Thus, this analysis of net benefits has not been used by OSHA as the basis for its decision concerning the choice of a PEL or of other ancillary requirements for the proposed beryllium rule.
        Table VII-5 shows net benefits using alternative discount rates of 0, 3, and 7 percent for benefits and costs, having previously included an adjustment to monetized benefits to reflect increases in real per capita income over time.  OSHA has relied on a uniform discount rate applied to both costs and benefits.  The Agency is interested in any evidence, theoretical or applied, that would support or refute the application of differential discount rates to the costs and benefits of a regulation.
      As previously noted in this chapter, the choice of discount rate for annualizing benefits has a significant effect on annualized benefits.  The same is true for net benefits.  For example, the net benefits using a 7 percent discount rate for benefits are considerably smaller than the net benefits using a 3 percent discount rate, declining by almost half under all scenarios.  (Conversely, as noted in Chapter V of this PEA, the choice of discount rate for annualizing costs has a relatively minor effect on annualized costs.)
      Based on the results presented in Table VII-5, OSHA finds:
   * While the net benefits of the proposed rule vary considerably -- depending on the choice of discount rate used to annualize benefits and on whether the benefits being used are in the high, midpoint, or low range -- benefits exceed costs for the proposed 0.2 μg/m[3] PEL in all cases that OSHA considered.
   * The Agency's best estimate of the net annualized benefits of the proposed rule -- using a uniform discount rate for both benefits and costs of 3 percent -- is between $2120 million and $1.2 billion, with a midpoint value of $538 million.
   * The alternative of a 0.5 μg/m[3] PEL has lower net benefits under all assumptions, except for the low-end benefits at 7%, whereas the effect on net benefits of the 0.1 μg/m[3] PEL is somewhat more mixed, relative to the proposed 0.2 μg/m[3] PEL.  However, for these alternative PELs, benefits were also found to exceed costs in all cases that OSHA considered.
STEP 4 - Incremental Benefits of the Proposed Rule
      Incremental costs and benefits are those that are associated with increasing the stringency of the standard. A comparison of incremental benefits and costs provides an indication of the relative efficiency of the proposed PEL and the alternative PELs.  Again, OSHA has conducted these calculations for informational purposes only and has not used these results as the basis for selecting the PEL for the proposed rule.
      OSHA provided, in Table VII-5, estimates of the net benefits of the alternative 0.1and 0.5 μg/m[3] PELs.  The incremental costs, benefits, and net benefits of meeting a 0.5μg/m[3] PEL and then going to a 0.2 μg/m[3] PEL (as well as meeting a 0.2 μg/m[3] PEL and then going to a 0.1 μg/m[3] PEL -- which the Agency has not yet determined is feasible), for alternative discount rates of 3 and 7 percent, are presented in Table VII-6.  Table VII-6 breaks out costs by provision and benefits by type of disease and by morbidity/mortality.  As Table VII-6 shows, at a discount rate of 3 percent, a PEL of 0.2 ug/m[3], relative to a PEL of 0.5 ug/m[3], imposes additional costs of $4.4 million per year; additional benefits of $172 million per year; and additional net benefits of $168 million per year.   The proposed PEL of 0.2 ug/m[3] also has higher net benefits, relative to a PEL of 0.5 ug/m[3], using a 7 percent discount rate.
      Table VII-6 demonstrates that, regardless of discount rate, there are net benefits to be achieved by lowering exposures from the current PEL of 2.0 μg/m[3] to 0.5 μg/m[3] and then, in turn, lowering them further to 0.2 μg/m[3].  However, the majority of the benefits and costs attributable to the proposed rule are from the initial effort to lower exposures to 0.5 μg/m[3].  Consistent with the previous analysis, net benefits decline across all increments as the discount rate for annualizing benefits increases.  As also shown in Table VII-6, there is a  small positive net incremental benefit from going from a PEL of 0.2 μg/m[3] to 0.1 μg/m[3], at 3 percent, but is slightly negative at 7 percent.  (Note that this result reflects OSHA's midpoint estimate of benefits, although as indicated in Table VII-5, this is not universal across all estimation parameters.)
      In addition to examining alternative PELs, OSHA also examined alternatives to other provisions of the standard.  These alternatives are discussed in the following Regulatory Alternatives chapter.

* Benefits are assessed over a 60-year time horizon, during which it is assumed that economic conditions remain constant.  Costs are annualized over ten years, with the exception of equipment expenditures, which are annualized over the life of the equipment.  Annualized costs are assumed to continue at the same level for sixty years, which is consistent with assuming that economic conditions remain constant for the sixty-year time horizon.
STEP 5 - SEnSITIVITY ANALYSIS
      In this section, OSHA presents the results of two different types of sensitivity analysis to demonstrate how robust the estimates of net benefits are to changes in various cost and benefit parameters. In the first type of sensitivity analysis, OSHA made a series of isolated changes to individual cost and benefit input parameters in order to determine their effects on the Agency's estimates of annualized costs, annualized benefits, and annualized net benefits.   In the second type of sensitivity analysis -- a so-called "break-even" analysis -- OSHA also investigated isolated changes to individual cost and benefit input parameters, but with the objective of determining how much they would have to change for annualized costs to equal annualized benefits.  For both types of sensitivity analyses, OSHA used the annualized costs and benefits obtained from a three-percent discount rate as the reference point.
      Again, the Agency has conducted these calculations for informational purposes only and has not used these results as the basis for selecting the PEL for the proposed rule.
Analysis of Isolated Changes to Inputs
      The methodology and calculations underlying the estimation of the costs and benefits associated with this rulemaking are generally linear and additive in nature.  Thus, the sensitivity of the results and conclusions of the analysis will generally be proportional to isolated variations in a particular input parameter.  For example, if the estimated time that employees need to travel to (and from) medical screenings were doubled, the corresponding labor costs would double as well.
      OSHA evaluated a series of such changes in input parameters to test whether and to what extent the general conclusions of the economic analysis held up.  OSHA first considered changes to input parameters that affected only costs and then changes to input parameters that affected only benefits.  Each of the sensitivity tests on cost parameters had only a very minor effect on total costs or net costs.  Much larger effects were observed when the benefits parameters were modified; however, in all cases, net benefits remained significantly positive.  On the whole, OSHA found that the conclusions of the analysis are reasonably robust, as changes in any of the cost or benefit input parameters still show significant net benefits for the proposed rule.  The results of the individual sensitivity tests are summarized in Table VII-7 and are described in more detail below.
      In the first of these sensitivity tests, where OSHA doubled the estimated portion of employees in need of protective clothing and equipment (PPE), essentially doubling the estimated baseline non-compliance rate (e.g., from 10 to 20 percent), and estimates of other input parameters remained unchanged, Table VII-7 shows that the estimated total costs of compliance would increase by $1.4 million annually, or by about 3.7 percent, while net benefits would also decline by $1.4 million annually, from $538.2 million to $536.8 million annually.
      In a second sensitivity test, OSHA increased the estimated unit cost of ventilation from $13.18 per cfm for most sectors to $25 per cfm for most sectors.  As shown in Table VII-7, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $2.0 million annually, or by about 5.3 percent, while net benefits would also decline by $2.0 million annually, from $538 million to $536 million annually.

* Benefits are assessed over a 60-year time horizon, during which it is assumed that economic conditions remain constant.  Costs are annualized over ten years, with the exception of equipment expenditures, which are annualized over the life of the equipment.  Annualized costs are assumed to continue at the same level for sixty years, which is consistent with assuming economic conditions remain constant for the sixty-year time horizon.

      In a third sensitivity test, OSHA increased the estimated share of workers showing signs and symptoms of CBD from 15 to 25 percent, thereby adding these workers to the group eligible for medical surveillance and assuming that they would not be otherwise eligible for another reason (working in a regulated area, exposed during an emergency, etc.)  As shown in Table VII-7, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $1.5 million annually, or by about 4.1 percent, while net benefits would also decline by $1.5 million annually, from $538 million to $537 million annually.
      In a fourth sensitivity test, OSHA increased its estimated incremental time per workers for housekeeping by 50 percent.  As shown in Table VII-7, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $5 million annually, or by about 14.4 percent, while net benefits would also decline by $5.4 million annually, from $538 million to $533 million annually.
      In a fifth sensitivity test, OSHA increased the estimated number of  establishments needing engineering controls.  For this sensitivity test, if 50 percent or less  of the establishments in an industry needed engineering controls, OSHA increased the percentage of establishments needing engineering controls by 100 percent.  If more than 50 percent of establishments in an industry needed engineering controls, then OSHA estimated that all establishments in that industry would need engineering controls.  The purpose of this sensitivity analysis was to check the importance of using a methodology that treated 50 percent of workers in a given occupation exposed above the PEL as equivalent to 50 percent of facilities lacking adequate exposure controls.  As shown in Table VII-7, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $4.5 million, or by about 11.9 percent, while net benefits would also decline by $4.5 million, from $538 million to $534 million annually.
      The Agency also performed sensitivity tests on several input parameters used to estimate the benefits of the proposed rule.  In the first two tests, in an extension of results previously presented in Table VII-3, the Agency examined the effect on annualized net benefits of employing the high-end estimate of the benefits, as well as the low-end estimate, specifically examining the effect on undiscounted benefits of varying the valuation of individual morbidity cases.  Table VII-7 presents the effect on annualized net benefits of using the extreme values of these ranges: the high morbidity valuation case and the low morbidity valuation case.  For the low estimate of valuation, the benefits decline by 37.7 percent, to $359 million annually, yielding net benefits of $322 million annually. As shown, using the high estimate of morbidity valuation, the benefits rise by 77 percent to $1.0 billion annually, yielding net benefits of $982 million annually.
      In a third sensitivity test of benefits, the Agency examined the effect of removing the component for the estimated rising value of health and safety over time.  This would reduce the benefits by 54.6 percent, or $262 million annually, lowering the net benefits to $224 million annually.
      Not part of this table, because it is reported elsewhere (e.g., in Table VII-6), the Agency examined the effect of raising the discount rate for costs and benefits to 7 percent.  Raising the discount rate to 7 percent would increase costs by $1.6 million annually and lower benefits by $321 million annually, yielding annualized net benefits of $216 million.
Sensitivity Analysis of Dental Lab Substitution
      As discussed in the Industry Profile (Chapter III), OSHA estimates that 75 percent of the dental laboratory industry will react to a new standard on beryllium by substituting away from using beryllium to the use of other materials. The basis for the estimated changes in the industry profile and cost estimates are described in the PEA in Profile Of Affected Industries (Chapter III), Costs of Compliance (Chapter V), and earlier in this chapter on benefits. However, because of uncertainties about the extent to which dental laboratories will substitute out of beryllium use in the future and the extent to which the future substitution is attributable to the OSHA beryllium rule, and because of the substantial portion of the net benefits accounted for by this sector, OSHA has provided a sensitivity analysis of the effect on benefits and costs of alternative substitution rates away from beryllium use in the dental laboratory sector.
      Substitution is not costless, and Chapter V estimates the increased cost due to the higher costs of using non-beryllium alloys.  But these costs are smaller than the avoided costs of the ancillary provisions and engineering controls.  Regardless, the net cost effect is swamped by the benefits to thousands of workers having their baseline beryllium exposures completely eliminated.  Thus, as indicated in Table VII-8, the benefits of the proposal would be lower and the costs higher if there were less substitution out of beryllium in dental labs.  The lowest net benefits would occur if labs were unable to substitute out beryllium-containing materials at all, and had to use ventilation to control exposures.  In this case, the proposal would yield only $420 million in net benefits.  The highest net benefits, larger than assumed for OSHA's primary estimate, would be if all dental labs substituted out of beryllium-containing materials as a result of the proposal; as a result, the proposal would yield $573 million in net benefits.
      Another possibility is a scenario is which technology and the market move along rapidly away from using beryllium-containing materials, independently of an OSHA rule, and the proposal itself would therefore produce neither costs nor benefits in this sector.   If dental labs are removed from the PEA, the net benefits for the proposal -- for the remaining industry sectors -- decline to $284 million.  Critically, however, this analysis demonstrates that regardless of any assumption regarding substitution in dental labs, the proposal would generate substantially more monetized benefits than costs.

"Break-Even" Analysis
      OSHA also performed sensitivity tests on several other parameters used to estimate the net costs and benefits of the proposed rule.  However, for these, the Agency performed a "break-even" analysis, asking how much the various cost and benefits inputs would have to vary in order for the costs to equal, or break even with, the benefits.  The results are shown in Table VII-9.
      In one break-even test on cost estimates, OSHA examined how much total costs would have to increase in order for costs to equal benefits.  As shown in Table VII-9, this point would be reached if costs increased by $538 million, or by 1,432 percent.
      In a second test, looking specifically at the estimated engineering control costs, the Agency found that these costs would need to increase by $567 million, or 6,240 percent, for costs to equal benefits.
      In a third sensitivity test, on benefits, OSHA examined how much its estimated monetary valuation of an avoided illness or an avoided fatality would need to be reduced in order for the costs to equal the benefits.  Since the total valuation of prevented mortality and morbidity are each estimated to exceed the estimated costs of $38 million, an independent break-even point for each is impossible.  In other words, for example, if no value is attached to an avoided illness associated with the rule, but the estimated value of an avoided fatality is held constant, the rule still has substantial net benefits.  Only through a reduction in the estimated net value of both components is a break-even point possible.
      The Agency, therefore, examined how large an across-the-board reduction in the monetized value of all avoided illnesses and fatalities would be necessary for the benefits to equal the costs.  As shown in Table VII-9, a 94 percent reduction in the monetized value of all avoided illnesses and fatalities would be necessary for costs to equal benefits, reducing the estimated value to $733,303 per fatality prevented, and an equivalent percentage reduction to about $4,048 per illness prevented.
      In a fourth break-even sensitivity test, OSHA estimated how many fewer beryllium-related fatalities and illnesses would be required for benefits to equal costs.  Paralleling the previous discussion, eliminating either the prevented mortality or morbidity cases alone would be insufficient to lower benefits to the break-even point.  The Agency therefore examined them as a group.  As shown in Table VII-9, a reduction of 94 percent, for both simultaneously, is required to reach the break-even point -- 90 fewer fatalities prevented annually, and 46 fewer beryllium-related illnesses-only cases prevented annually.
      Taking into account both types of sensitivity analysis the Agency performed on its point estimates of the annualized costs and annualized benefits of the proposed rule, the results demonstrate that net benefits would be positive in all cases tested.  In particular, this finding would hold even with relatively large variations in individual input parameters. Alternately, one would have to imagine extremely large changes in costs or benefits for the rule to fail to produce net benefits.  OSHA concludes that its finding of significant net benefits resulting from the proposed rule is a robust one.
      OSHA welcomes input from the public regarding all aspects of this sensitivity analysis, including any data or information regarding the accuracy of the preliminary estimates of compliance costs and benefits and how the estimates of costs and benefits may be affected by varying assumptions and methodological approaches.  OSHA also invites comment on the risk analysis and risk estimates from which the benefits estimates were derived.

CBD Prevalence/Incidence and Mortality Ratio Sensitivity Analysis
      Finally, the Agency examined the effects of changes in two important inputs to the benefits analysis: the factor that transforms CBD prevalence rates into incidence rates, needed for the equilibrium lifetime risk model, and the percentage of CBD cases that eventually lead to a fatality.
      From the Cullman dataset the Agency has estimated the prevalence of CBD cases at any point in time as a function of cumulative beryllium exposure. In order to utilize the lifetime risk model, which tracks workers over their working life in a job, OSHA has turned these prevalence rates into an incidence rate, which is the rate of contracting CBD at a point in time. OSHA's baseline estimate of the turnover rate in the model is 10%.  OSHA also presents alternative turnover rates of 5% and 20% in the top panel of Table VII-10.  A higher turnover rate translates into a higher incidence rate, and the table shows that, from a baseline midpoint estimate with 10% turnover the number of CBD cases prevented is 6,367, while raising the turnover rate to 20% causes this midpoint estimate to rise to 11,751.  Conversely, a rate of 5% lowers the number of CBD cases prevented to 3,321.  Translated into monetary benefits, the table shows that the baseline midpoint estimate of $575.8m now ranges from $314.4m to $1,038m.
      Second, the Agency looks at the effects of varying the percentage of CBD cases that eventuate in fatality.  The Agency's baseline estimate of this outcome is 65%, with half of this occurring relatively soon, and the other half after an extended debilitating condition.  The Agency judged that a reasonable range to investigate was a low of 50% and a high of 80%, while maintaining the shares of short-term and long-term endpoint fatality.  The lower panel of Table VII-10 presents these results, here for CBD fatalities, versus the upper panel which is for overall CBD cases.  At a baseline of 65%, the midpoint estimate of total CBD cases prevented is 4,139. At the low end of 50% mortality this estimate lowers to 3,183 while at the high end of 80% mortality this estimate rises to 5,094.  Translated into monetary benefits, the table shows that the baseline midpoint estimate of $575.8m now ranges from $500.1m to $651.5m.

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      Appendix VII-A     Estimated Benefits of the Standard by Year* **
* Notes to Table VII-A-1:  (a) all cases prevented in the left columns appear as rounded integers, but the actual value is used in all calculations -- this is also true for some values that appear as 0 (i.e., other than those described in (d) below); (b) the number of fatal CBD cases prevented in year i represents the number of (ultimately) fatal CBD cases that are diagnosed in year i -- the actual fatality is estimated to occur 20 years later; (c) the undiscounted value of prevented fatal lung cancers in year i is equal to the number of cases of lung cancer prevented in that year x $8.7 million x (1.02)^i; (d) because of the 10-year lag from exposure to disease for lung cancer, there are no fatal lung cancer benefits for years 1-10; (e) the undiscounted value of morbidity before death for fatal CBD in year i is equal to the number of cases of fatal CBD prevented in that year x $2.58 million x (1.02)^i; (f) the undiscounted mortality value of fatal CBD in year i is equal to [the number of cases of fatal CBD prevented in year (i - 20)] x $8.7 million x (1.02)^i -- for example, the $26.4 million of undiscounted CBD mortality benefits reported in year 21 is based on the 2 fatal CBD cases diagnosed in year 1; (g) because of the estimated 20-year lag from diagnosis of CBD to death, there are no mortality benefits for CBD estimated for years 1-20 and no mortality benefits were taken for CBD cases diagnosed in years 41-60 (since death would occur beyond the 60-year time horizon selected for the estimation of benefits); (h) the undiscounted fatality total value is equal to the sum of the three columns to the left; (i) the undiscounted grand total value is equal to the sum of the two columns to the left; and (j) every cell in the "Present Value by Year After Promulgation  -  3% Discount Rate ($M)" columns is equal to the corresponding cell in the "Undiscounted Value of Cases Prevented by Year After Promulgation ($M)" columns multiplied by 1/(1.03)^i.

** Notes to Table VII-A-2:  (a) all cases prevented in the left columns appear as rounded integers, but the actual value is used in all calculations -- this is also true for some values that appear as 0 (i.e., other than those described in (d) below); (b) the number of fatal CBD cases prevented in year i represents the number of (ultimately) fatal CBD cases that are diagnosed in year i -- the actual fatality is estimated to occur 20 years later; (c) the undiscounted value of prevented fatal lung cancers in year i is equal to the number of cases of lung cancer prevented in that year x $8.7 million x (1.02)^i; (d) because of the 10-year lag from exposure to disease for lung cancer, there are no fatal lung cancer benefits for years 1-10; (e) the undiscounted value of morbidity before death for fatal CBD in year i is equal to the number of cases of fatal CBD prevented in that year x $2.58 million x (1.02)^i; (f) the undiscounted mortality value of fatal CBD in year i is equal to [the number of cases of fatal CBD prevented in year (i - 20)] x $8.7 million x (1.02)^i -- for example, the $26.4 million of undiscounted CBD mortality benefits reported in year 21 is based on the 2 fatal CBD cases diagnosed in year 1; (g) because of the estimated 20-year lag from diagnosis of CBD to death, there are no mortality benefits for CBD estimated for years 1-20 and no mortality benefits were taken for CBD cases diagnosed in years 41-60 (since death would occur beyond the 60-year time horizon selected for the estimation of benefits); (h) the undiscounted fatality total value is equal to the sum of the three columns to the left; (i) the undiscounted grand total value is equal to the sum of the two columns to the left; and (j) every cell in the "Present Value by Year After Promulgation  -  7% Discount Rate ($M)" columns is equal to the corresponding cell in the "Undiscounted Value of Cases Prevented by Year After Promulgation ($M)" columns multiplied by 1/(1.07)^i.

CHAPTER VIII: REGULATORY ALTERNATIVES

	This chapter discusses various regulatory alternatives to the proposed OSHA beryllium standard.  Executive Order 12866 instructs agencies to "select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity), unless a statute requires another regulatory approach."  The OSH Act, as interpreted by the courts, requires health regulations to reduce significant risk to the extent feasible. Nevertheless OSHA has examined possible regulatory alternatives that may not meet its statutory requirements.
      Each regulatory alternative presented here is described and analyzed relative to the proposed rule. Where appropriate, the Agency notes whether the regulatory alternative, to be a legitimate candidate for OSHA consideration, requires evidence contrary to the Agency's preliminary findings of significant risk and feasibility.  To facilitate comment, OSHA has organized some two dozen specific regulatory alternatives into five categories: (1) scope; (2) exposure limits; (3) methods of compliance; (4) ancillary provisions; and (5) timing.
 SCOPE ALTERNATIVES
      The first set of regulatory alternatives would alter scope of the proposed standard -- that is, the groups of employees and employers covered by the proposed standard.  The scope of the current beryllium proposal applies only to general industry work, and does not apply to employers when engaged in construction or maritime activities. In addition, the proposed rule provides an exemption for those working with materials that contain beryllium only as a trace contaminant (less than 0.1% composition by weight).
      As discussed in the explanation of paragraph (a) in Section XVIII of the preamble, Summary and Explanation of the Proposed Standard, OSHA is considering alternatives to the proposed scope that would increase the range of employers and employees covered by the standard.  OSHA's review of several industries indicates that employees in some construction and maritime industries, as well as some employees who deal with materials containing less than 0.1% beryllium, may be at significant risk of CBD and lung cancer as a result of their occupational exposures. Regulatory Alternatives #1a, #1b, #2a, and #2b would increase the scope of the proposed standard to provide additional protection to these workers.
      Regulatory Alternative #1a would expand the scope of the proposed standard to also include all operations in general industry where beryllium exists only as a trace contaminant; that is, where the materials used contain less than 0.1% beryllium by weight.  Regulatory Alternative #1b offers an exemption for operations where beryllium exists only as a trace contaminant and the employer can show that employees' exposures will not meet or exceed the action level or exceed the STEL. Either through initial monitoring or where the employer has objective data demonstrating that a material containing beryllium or a specific process, operation, or activity involving beryllium cannot release beryllium in concentrations at or above the proposed action level or above the proposed STEL under any expected conditions of use, that employer would be exempt from the proposed standard except for recordkeeping requirements pertaining to the objective data.  Alternative #1a and Alternative #1b, like the proposed rule, would not cover employers or employees in construction or shipyards.
      OSHA has identified two industries with workers engaged in general industry work that would be excluded under the proposed rule but would fall within the scope of the standard under Regulatory Alternatives #1a and #1b: primary aluminum production and coal-fired power generation.
      Beryllium exists as a trace contaminant in aluminum ore and may result in exposures above the proposed permissible exposure limits (PELs) during aluminum refining and production.  In primary aluminum production, OSHA's exposure data indicate that some jobs, mostly pot room-related, have exposures to beryllium that may exceed the proposed TWA PEL (see Appendix VIII-A at the end of this chapter).  Drawing on the information presented in Appendix IV-A at the end of Chapter IV of this PEA, all feasible engineering controls and work practices for this industry were analyzed and then applied to the industrial profile to calculate engineering and work practice costs associated with this alternative ($1.9 million, presented in Appendix VIII-A at the end of this chapter).
      Coal fly ash in coal-powered utility facilities also contains trace amounts of beryllium, which may become airborne and result in worker exposures. OSHA's exposure profile shows that most exposure samples collected in these facilities after the 1980s do not exceed the proposed action level of 0.1 ug/m3 (see Appendix VIII-B at the end of this chapter).  On occasion, workers performing maintenance activities such as baghouse cleaning and boiler rebuilding may be exposed to levels of beryllium that exceed the proposed PELs.  These maintenance activities also involve potential exposures to arsenic and other contaminants present in fly ash.  Coal-fired power plants must ensure that they are in compliance with OSHA's Inorganic Arsenic standard (29 CFR 1910.1018) .  As discussed in Appendix IV-B, beryllium exposures from fly ash high enough to exceed the proposed PEL would usually be coupled with arsenic exposures exceeding the arsenic PEL. Employers would in that case be required to implement all feasible engineering controls, work practices, and necessary PPE (including respirators) to comply with the OSHA Inorganic Arsenic standard (29 CFR 1910.1018) -- which would be sufficient to comply with those aspects of the proposed beryllium standard as well.   Therefore, OSHA has judged that a reduction of the beryllium PEL would not impose costs for additional engineering controls or respiratory protection in coal-fired utilities.  The arsenic standard also contains ancillary provisions similar to some of the proposed provisions for beryllium, such as requirements for personal protective equipment, housekeeping, and hygiene practices; but it does not contain all requirements in the proposed beryllium standard, such as requirements for a written exposure control plan, a medical surveillance program, and medical removal protection specific to beryllium.  The degree of overlap between the applicability of the two standards and, hence, the increment of costs attributable to this alternative are difficult to gauge. To account for this uncertainty, the Agency at this time is presenting a range of costs for Regulatory Alternative #1a: from no costs being taken for ancillary provisions under Regulatory Alternative #1a to all such costs being included. At the low end, the only additional costs under Regulatory Alternative #1a are due to the engineering control costs incurred by the aluminum smelters (see Appendix VIII-A).
      Similarly, the proposed beryllium standard would not result in additional benefits from a reduction in the beryllium PEL or from ancillary provisions similar to those already in place for the arsenic standard, but OSHA does anticipate some benefits will flow from ancillary provisions unique to the proposed beryllium standard.  To account for significant uncertainty in the benefits that would result from the proposed beryllium standard for workers in primary aluminum production and coal-fired power generation, OSHA estimated a range of benefits for Regulatory Alternative #1a.  The Agency estimated that the proposed ancillary provisions would avert between 0 and 45 percent of those baseline CBD cases not averted by the proposed PEL.  Though the Agency is presenting a range for both costs and benefits for this alternative, the Agency judges the degree of overlap with the arsenic standard is likely to be substantial, so that the actual costs and benefits are more likely to be found at the low end of this range. The Agency invites comment on all these issues.
      Table VIII-1 presents, for informational purposes, the estimated costs, benefits, and net benefits of Regulatory Alternative #1a using alternative discount rates of 3 percent and 7 percent.  In addition, this table presents the incremental costs, incremental benefits, and incremental net benefits of this alternative relative to the proposed rule.  Table VIII-1 also breaks out costs by provision, and benefits by type of disease and by morbidity/mortality.  (Note: "morbidity" cases are cases where health effects are limited to non-fatal illness; in these cases there is no further disease progression to fatality).
      As shown in Table VIII-1, Regulatory Alternative #1a would increase the annualized cost of the rule from $37.6 million to somewhere between $39.6 and $56.0 million using a 3 percent discount rate and from $39.1 million to somewhere between $41.3 and $58.1 million using a 7 percent discount rate. OSHA estimates that Regulatory Alternative #1a would prevent as few as an additional 0.3 (i.e., almost one fatality every 3 years) or as many as an additional 31.8 beryllium-related fatalities annually, relative to the proposed rule. OSHA also estimates that Regulatory Alternative #1a would prevent as few as an additional 0.002 or as many as an additional 9 beryllium-related non-fatal illnesses annually, relative to the proposed rule. As a result, annualized benefits in monetized terms would increase from $575.8 million to somewhere between $578 million and $765.2 million, using a 3 percent discount rate, and from $255.3 million to somewhere between $256.3 and $339.3 million using a 7 percent discount rate.  Net benefits would change from $538.2 million to somewhere between $538.4 and $709.2 million using a 3 percent discount rate and from $216.2 million to somewhere between $215.1 and $281.2 million using a 7 percent discount rate.
      OSHA estimates that the costs and the benefits of Regulatory Alternative #1b would be somewhat lower than those of Regulatory Alternative #1a, because most -- but not all -- of the provisions of the proposed standard are triggered only by exposures at the action level, 8-hour time-weighted average (TWA) PEL, or STEL.  For example, where exposures exist but are below the action level and at or below the STEL, Regulatory Alternative #1a would require employers to establish work areas; develop, maintain, and implement a written exposure control plan; provide medical surveillance to employees who show signs or symptoms of CBD; and provide PPE in some instances.  Regulatory Alternative #1b would not require employers to take these measures in operations where they can show, either through monitoring or objective data, that exposures are below the action level and at or below the STEL under any expected conditions of use.  And, of course, like Regulatory Alternative #1a, these changes would only affect the two industries of aluminum production and coal-fired utilities.
      ERG estimated the share of aluminum smelters and coal-fired power plants that would be exempt using objective data and reduced the ancillary provision, respirator, and engineering control costs of Regulatory Alternative #1a by this exemption share. Given that aluminum smelters have some workers above the PEL and will need to install engineering controls (see Appendix VIII-A), ERG set the smelter exemption share at zero. For coal-fired power plants, Appendix VIII-B estimates that 75 percent of all production workers are below the action level. With these relatively low levels of beryllium exposures at coal-fired power plants, ERG set the exemption share for this sector using objective data to meet the Alternative #1b exemption at 50 percent.  The Agency invites comment on these estimates.  OSHA only analyzed costs, not benefits, for this alternative, consistent with the Agency's treatment of Regulatory Alternatives in the past.  The costs are presented in Table VIII-7.  Total costs for Regulatory Alternative #1b versus #1a, assuming full ancillary costs, drop from to $56.0 million to $49.9 million using a 3 percent discount rate, and from $58.1 million  to $51.8 million using a 7 percent discount rate.

      Regulatory Alternative #2a would expand the scope of the proposed standard to also include employers in construction and maritime.  For example, this alternative would cover abrasive blasters, pot tenders, and cleanup staff working in construction and shipyards who have the potential for airborne beryllium exposure during blasting operations and during cleanup of spent media.  Regulatory Alternative #2b would, in addition to the proposed beryllium standard for general industry, update 29 CFR 1910.1000 Tables Z-1 and Z-2, 1915.1000 Table Z, and 1926.55 Appendix A so that the proposed TWA PEL and STEL would apply to all employers and employees in general industry, shipyards, and construction, including occupations where beryllium exists only as a trace contaminant.   Thus, under Regulatory Alternative #2b, the changes to the Z tables would apply to workers exposed to beryllium during aluminum refining and production and workers exposed in  coal-powered utility facilities, in addition to workers in construction and shipyards. All provisions of the standard other than the PELs, such as exposure monitoring, medical removal, and PPE, would be in effect only for employers and employees that fall within the scope of the proposed rule.  Alternative #2b would not extend ancillary provisions to construction, to maritime, or to those operations in general industry where beryllium is present only as a trace contaminant, such as aluminum smelting and coal-fired utilities.
      As discussed in the explanation of proposed paragraph (a) in this preamble at Section XVIII, Summary and Explanation of the Proposed Standard, abrasive blasting is the primary application group in construction and maritime industries where workers may be exposed to beryllium.  OSHA has judged that abrasive blasters and their helpers in construction and maritime industries have the potential for significant airborne exposure during blasting operations and during cleanup of spent media.  Airborne concentrations of beryllium have been measured above the current TWA PEL of 2 μg/m3 when blast media containing beryllium are used as intended (see Appendix IV- C in this PEA for details).   As discussed in Appendix VIII-C of this PEA, national employment statistics only estimate total employees in the abrasive blasting sector, not a breakdown between operators and various helpers, and provide no information on which workers use blasting materials that contain beryllium. To supplement these total figures, interviews were conducted with members of industry (ERG, 2014).  From these conversations OSHA preliminarily estimates that 50 percent of operators and helpers in construction and 80 percent in shipyards use blast media containing beryllium. OSHA also estimates an average of 1.5 helpers per operator for both sectors (ERG, 2014). The Agency requests comment on these estimates.
      To address high concentrations of various hazardous chemicals in abrasive blasting material, employers must already be using engineering and work practice controls to limit workers' exposures and must be supplementing these controls with respiratory protection when necessary.  For example, abrasive blasters in the construction industry fall under the protection of the Ventilation standard (29 CFR 1926.57), as well as OSHA standards regulating other toxic substances found in coal  slag (e.g., nickel (29 CFR 1926.55 App. A)).  The Ventilation standard includes an abrasive blasting subsection (29 CFR 1926.57(f)), which requires that abrasive blasting respirators be worn by all abrasive blasting operators when working inside blast-cleaning rooms (29 CFR 1926.57(f)(5)(ii)(A)), or when using silica sand in manual blasting operations where the nozzle and blast are not physically separated from the operator in an exhaust-ventilated enclosure (29 CFR 1926.57(f)(5)(ii)(B)), or when needed to protect workers from exposures to hazardous substances in excess of the limits set in §1926.55 (29 CFR 1926.57(f)(5)(ii)(C); ACGIH, 1970). For maritime, standard 29 CFR 1915.34(c) covers similar requirements for respiratory protection needed in blasting operations.  Due to these requirements, OSHA believes that abrasive blasting operators already have required controls in place and wear appropriate respiratory protection during blasting operations. Pot tenders, cleanup workers, and other helpers in blasting operations do not have similarly stringent protections. However, beryllium exposure due to blasting materials (coal slag) is associated with large amounts of dust; therefore OSHA judges that helpers would already be wearing the level of PPE that would be required by the proposed beryllium standard.  An earlier NIOSH study (NIOSH, 1995; Table 1) found a very high percentage of pot tenders used respirators while performing their duties.  OSHA requests comment on whether employers in abrasive blasting operations using blast material that contain beryllium as a trace contaminant are already using all feasible engineering and work practice controls, and ensuring the use of respiratory protection and PPE that would be required by Regulatory Alternative #2a. OSHA also requests comment on the type and frequency of use of respirators among abrasive blasting operators and helpers, as well as the numbers of blasting operators and helpers employed in construction and shipyards.
      In the estimation of benefits for Regulatory Alternative #2a, OSHA has estimated a range to account for significant uncertainty in the benefits to this population from some of the ancillary provisions of the proposed beryllium standard.  It is unclear how many of the workers associated with abrasive blasting work would benefit from dermal protection, as comprehensive dermal protection may already be used by most blasting operators.  It is also unclear whether the housekeeping requirements of the proposed standard would be feasible to implement in the context of abrasive blasting work, and to what extent they would benefit blasting helpers, who are themselves exposed while performing cleanup activities. OSHA estimated that the proposed ancillary provisions would avert between 0 and 45 percent of those baseline CBD cases not averted by the proposed PEL.
      These considerations also lead the Agency to present a range for the costs of this alternative: from no costs being taken for ancillary provisions under Regulatory Alternative #2a to including all such costs.  Based on the considerations discussed above, the Agency judges that costs and benefits at the low end of this range are more likely to be correct.  The Agency invites comment on these issues.
      In addition to abrasive blasters, OSHA believes that a small number of welders in the maritime industry may be exposed to beryllium via arc and gas welding (and none through resistance welding).  The number of maritime welders was estimated using the same methodology as was used to estimate the number of general industry welders. Brush Wellman's customer survey estimated 2,000 total welders on beryllium-containing products (Kolanz, 2001).  Based on ERG's assumption of 4 welders per establishment, ERG estimated that a total of 500 establishments would be affected. These affected establishments were then distributed among the 26 NAICS industries with the highest number of IMIS samples for welders that were positive for beryllium. To do this, ERG first consulted the BLS OES survey to determine what share of establishments in each of the 26 NAICS employed welders and estimated the total number of establishments that perform welding regardless of beryllium exposure (BLS, 2010). Then ERG distributed the 500 affected beryllium welding facilities among the 26 NAICS based on the relative share of the total number of establishments performing welding. Finally, to estimate the number of welders, ERG again used the assumption of 4 welders per establishment. Based on the information from ERG, OSHA estimated that 30 welders would be covered in the maritime industry under this regulatory alternative.  For these welders, OSHA used the same controls and exposure profile that were used to estimate costs for arc and gas welders in Chapter V of this PEA.  ERG judged there to be no construction welders exposed to beryllium because there is no evidence indicating that construction welders performing arc or gas welding work to a significant degree with beryllium-containing metals; nor is resistance welding with beryllium alloy electrodes likely to be done in a construction setting.  OSHA solicits comment and any relevant data on beryllium exposures for welders in construction and maritime employment.
      Table VIII-2 presents the estimated costs, benefits, and net benefits of Regulatory Alternatives #2a using alternative discount rates of 3 percent and 7 percent.  In addition, this table presents the incremental costs, incremental benefits, and incremental net benefits of these alternatives relative to the proposed rule.  Table VIII-2 also breaks out costs by provision and benefits by type of disease and by morbidity/mortality.  Because the small group of welders in maritime has exposures over the PEL, has different working conditions than blasting operations, and is not subject to the same blasting OSHA standards, even the low range of costs and benefits is non-zero for this group, and hence for this alternative.
      As shown in Table VIII-2, Regulatory Alternative #2a would increase costs from $37.6 million to between $37.7 and $55.3 million, using a 3 percent discount rate, and from $39.1 million to between $39.2 and $57.3 million using a 7 percent discount rate.  Annualized benefits would increase from $575.8 million to between $575.9 and $675.3 million using a 3 percent discount rate, and from $255.3 million to between $255.4 and $675.3 million using a 7 percent discount rate.  Net benefits would change from $538.2 million to between $538.2 and $620.0 million using a 3 percent discount rate, and from $216.2 million to between $216.1 and $242.1 million using a 7 percent discount rate.
      As shown in Table VIII-3, Regulatory Alternative #2b would increase the annualized cost of the rule from $37.6 million to $39.6 million using a 3 percent discount rate, and would increase the annualized cost of the rule from $39.1 to $41.1 million using a 7 percent discount rate.  Regulatory Alternative #2b would prevent less than one additional beryllium-related fatality and less than one additional beryllium-related illness annually relative to the proposed rule. As a result, annualized benefits would increase from $575.8 million to $578.1 million using a 3 percent discount rate, and from $255.3 million to $256.3 million using a 7 percent discount rate.  Net benefits would increase from $538.2 million to $538.5 million using a 3 percent discount rate, and decrease from $216.2 million to $215.2 million using a 7 percent discount rate.

Exposure Limit (TWA PEL, STEL, and ACTION LEVEL) AlternativeS

      OSHA is proposing a new TWA PEL for beryllium of 0.2 μg/m[3] and a STEL of 2.0 μg/m[3] for all application groups covered by the rule.  OSHA's proposal is based on the requirements of the Occupational Safety and Health Act (OSH Act) and court interpretations of the Act.  For health standards issued under section 6(b)(5) of the OSH Act, OSHA is required to promulgate a standard that reduces significant risk to the extent that it is technologically and economically feasible to do so.  See Section II of the preamble, Pertinent Legal Authority, for a full discussion of OSHA legal requirements.
      Paragraph (c) of the proposed standard establishes two PELs for beryllium in all forms, compounds, and mixtures: an 8-hour TWA PEL of 0.2 μg/m[3] (proposed paragraph (c)(1)), and a 15-minute short-term exposure limit (STEL) of 2.0 μg/m[3] (proposed paragraph (c)(2)).  OSHA has defined the action level for the proposed standard as an airborne concentration of beryllium of 0.1 μg/m[3] calculated as an eight-hour TWA (proposed paragraph (b)).  In this proposal, as in other standards, the action level has been set at one-half of the TWA PEL.
      As discussed in the preamble explanation of paragraph (c) in Section XVIII, Summary and Explanation of the Proposed Standard, OSHA is considering three regulatory alternatives that would modify the PELs for the proposed standard.
      Regulatory Alternative #3 would modify the proposed STEL to be five times the TWA PEL, as is typical for OSHA standards that have STELs.  A STEL five times the TWA PEL has more practical effect because a STEL ten times the TWA PEL will rarely be exceeded without also driving exposures above the TWA PEL.  For example, assuming a background exposure level of 0.1 ug/m[3], a STEL ten times the TWA PEL could only be exceeded once in a work shift for 15 minutes without driving exposures above the TWA PEL, whereas a STEL five times the TWA PEL could be exceeded three times before driving exposures above the TWA PEL.  OSHA's standards for methylene chloride (29 CFR 1910.1052), acrylonitrile (29 CFR 1910.1045), benzene (29 CFR 1910.1028), ethylene oxide (29 CFR 1910.1047), and 1,3-Butadiene (29 CFR 1910.1051) all set STELs at five times the TWA PEL.  Thus, if OSHA promulgates the proposed TWA PEL of 0.2 μg/m[3], the accompanying STEL under this regulatory alternative would be set at 1 μg/m[3].
      As discussed in the preamble at Section V of the preamble, Health Effects, immunological sensitization can be triggered by short-term exposures.  OSHA believes a STEL for beryllium will help reduce the risk of sensitization and CBD in beryllium-exposed employees.  For instance, without a STEL, workers' exposures could be as high as 6.4 μg/m[3] (32 x 0.2 μg/m[3]) for 15 minutes under the proposed TWA PEL, if exposures during the remainder of the 8-hour work shift are non-detectable.  A STEL serves to minimize high task-based exposures by requiring feasible controls in these situations, and has the added effect of further reducing the TWA exposure.
      OSHA requests comment on the range of short-term exposures in covered industries, the types of operations where these are occurring, and on the proposed and alternative STELs, including any data or information that may help OSHA choose between them.
      OSHA identified two job categories where workers would be expected to have short-term exposures in the range between the proposed STEL and the STEL under Regulatory Alternative #3 (that is, between 2.0 and 1.0 μg/m[3]): furnace operators in nonferrous foundries and material preparation operators in the beryllium oxide ceramics application group.  To estimate the costs for this alternative, OSHA assumed that all workers in these job categories would need to wear respirators to meet a STEL of 1.0, though exposures might not actually warrant respirator use for all such workers.  OSHA also estimated costs for additional regulated areas and medical surveillance for workers in these two job categories.  The costs for this alternative are presented in Table VIII-4.  Total costs rise from $37.6 million to $37.7 million using a 3 percent discount rate and from $39.1 million to $39.3 million using a 7 percent discount rate.

      Under Regulatory Alternative #4, the TWA PEL would be 0.1 ug/m[3] with an action level of 0.05 ug/m[3].  The Agency's preliminary risk assessment indicates that the risks remaining at the proposed TWA PEL of 0.2 ug/m[3] -- while lower than risks at the current TWA PEL -- are still significant (see the preamble at Section VIII, Significance of Risk).  A TWA PEL of 0.1 ug/m[3] would reduce some of the remaining risks to workers at the proposed PEL.  The OSH Act requires the Agency to set its standards to address significant risks of harm to the extent economically and technologically feasible, so OSHA would have very limited flexibility to adopt a higher PEL if a lower PEL is technologically and economically feasible.
      While OSHA's preliminary analysis indicates that the proposed TWA PEL of 0.2 ug/m[3] is economically and technologically feasible, OSHA has less confidence in the feasibility of a TWA PEL of 0.1 ug/m[3].  In some industry sectors it is difficult to determine whether a TWA PEL of 0.1 ug/m[3] could be achieved in most operations most of the time (see Section IX.D of the preamble, Technological Feasibility).  OSHA believes that one way this uncertainty could be resolved would be with additional information on exposure control technologies and the exposure levels that are currently being achieved in these industry sectors.  OSHA requests additional data and information to inform its final determinations on feasibility (see Section IX.D of the preamble, Technological Feasibility) and the alternative PELs under consideration.