Comments Concerning OSHA’s Failure to Set Adequate Standards for Occupational Exposure to Beryllium
OSHA Docket Office
Docket No. H-005c
U.S. Department of Labor
200 Constitution Ave, NW
Washington, DC 20210
To Whom It May Concern:
Public Citizen submits these comments in response to the Occupational Safety and Health Administration’s (OSHA’s) November 26, 2002, Request for Information on Occupational Exposure to Beryllium. As OSHA is aware, on September 3, 2001, Public Citizen, along with the Paper, Allied-Industrial, Chemical and Energy Workers International Union (PACE) submitted a petition asking the agency to lower its permissible exposure limit (PEL) from 2 μg/m3 to 0.2 μg/m3. In that petition we asked for an Emergency Temporary Standard, which the agency rejected. However, we also stated: “In the event that an ETS is not granted, we request that you immediately initiate the usual rulemaking process as described in 29 USC 655(f).” Your November 12, 2002, rejection of our request for an ETS failed to even mention that we had, in the alternative, suggested a regular rulemaking procedure. We therefore do not believe that our petition has received the full consideration to which it is entitled by law. Thus, our comments to the docket do not in any way endorse the Request for Information as an adequate response to our petition. Indeed, the primary purpose of the Request for Information appears to be to buy the agency some time collecting information that would best be collected in a rulemaking procedure. For the same reason, our response is not a comprehensive response to the many questions posed by the agency. In any event, much of this information has already been collected by the Department of Energy (DOE), which, although not primarily an occupational health agency, acted to protect its contractors three years ago by setting the same standard for which we have petitioned (0.2 μg/m3). At this rate, it will be a decade or more before OSHA follows suit.
Some of the sought-after information can be derived from data already in the agency’s possession. In particular, we have conducted and submitted to a medical research conference a study based on OSHA’s own Integrated Management Information System (IMIS) database. In brief, we sought to evaluate industry compliance with the OSHA PEL of 2 mg/m3 as an eight-hour, time-weighted average (TWA) and the agency’s short-term exposure limit (STEL) of 5 mg/m3. We analyzed IMIS data for beryllium measurements conducted during state or federal OSHA inspections in the years 1990-1999. There were a total of 5168 workplace beryllium measurements, of which 9% were TWA measurements, 3% were STEL measurements, and 88% were measurements in which no beryllium was detected (tests for beryllium are often part of a panel that tests for several different metals). A statistically significant decrease of 44 measurements per year was found for the study period (R2=0.69, p=0.003, linear regression). Among measurements in which beryllium was detected (if no beryllium is detected, the IMIS database does not indicate whether the measurement is a TWA or a STEL), the median TWA value was 0.12 mg/m3 and the median STEL value was 0.10 mg/m3. Among these same measurements, 12% of TWA values were above the OSHA PEL, as were 6% of STEL measurements. Fifty-six percent of the TWA values were below 0.2 mg/m3, the PEL requested by Public Citizen and PACE. Although no significant trend for the total number of citations issued was found over the study period, citations issued for overexposure decreased significantly from 9 in 1990 to 0 in 1999 (R2=0.63, p=0.006, linear regression). We concluded that, while there is still non-compliance with the OSHA PEL, over half of the TWA measurements in which beryllium was detected were below 0.2 mg/m3. This suggests that compliance with a substantially reduced PEL has already occurred, at least in some industries. The decline in numbers of measurements is consistent with declines in OSHA enforcement seen in previous studies.
The current OSHA standard of 2.0 μg/m3 was originally established in 1949, more than 50 years ago, by the Atomic Energy Commission (AEC) in an effort to combat Acute Beryllium Disease (ABD). In the 1940s, 7% of beryllium workers developed ABD, of whom 10% died shortly after exposure; many of those surviving went on to develop chronic beryllium disease (CBD). While the 1949 AEC standard effectively eliminated ABD, a 1958 AEC report indicated that the AEC knew beryllium was toxic at lower levels, but considered the risk acceptable “because of the relatively small numbers of people involved.” The Occupational Safety and Health Act passed in 1970 and OSHA adopted the 2.0 μg/m3 AEC standard as a consensus standard in 1971 when the agency began its operations.
In 1977, NIOSH recommended that OSHA reduce the PEL for beryllium to a TWA of 0.5 μg/m3 because of its carcinogenicity.That year, OSHA itself proposed reducing the PEL to a TWA of 1 μg/m3. DOE and Department of Defense (DOD) officials objected, claiming that stricter OSHA standards would threaten national security due to an interrupted beryllium supply. The Secretary of Energy stated in a letter to the Secretaries of Labor and Health, Education, and Welfare (now the Department of Health and Human Services), “Clearly, cessation of beryllium metal and/or beryllium oxide production is unacceptable and would significantly degrade our national defense effort.”Twenty-six years after this proposal, OSHA has yet to publish a new standard, leaving the current standard at an out-of-date TWA of 2.0 μg/m3.
Beginning in the 1980s, the results of lymphocyte proliferation testing (LPT), a measure of immune sensitization to beryllium, brought increasing attention to the inadequacy of the existing OSHA standard. More and more workers with limited exposures developed sensitization and, later, CBD. Reacting to the growing evidence of beryllium toxicity, the American Conference of Governmental Industrial Hygienists (ACGIH) proposed a Threshold Limit Value (analogous to a PEL) of 0.2 μg/m3 as a TWA in 1998.
In a 1998 letter to the DOE, Assistant Secretary for Labor Charles Jeffress even went so far as to criticize DOE for not lowering the PEL from the OSHA level of 2.0 μg/m3, claiming that,
OSHA’s intention is to proceed with a full rulemaking on this substance which will, in part, presumably lower the PEL . . . because we now believe that our 2 μg/m3 PEL does not adequately protect beryllium-exposed workers from developing chronic beryllium disease, and there are adequate exposure and health effects data to support this rulemaking.
On September 17, 1999, Mr. Jeffress reiterated that, “. . . our current permissible exposure limits for beryllium in the workplace now appear to be too high to prevent chronic beryllium disease.” The agency has even acknowledged that, under the current 2.0 μg/m3 OSHA standard, 2-10% of exposed workers have developed CBD.Nonetheless, the agency has made only vague claims of proposed regulatory action and concrete actions are nowhere in sight.
Ironically, two decades after having helped to thwart OSHA’s efforts to enact a safer standard, DOE (which in part replaced the AEC) found that 1.2% of its present and former nuclear weapons employees and contract workers who had been screened had been diagnosed with CBD and an additional 2.5% had been sensitized to beryllium. DOE published a rule effective January 7, 2000, according to which DOE and its contractors must establish a program to reduce beryllium exposure to 0.2 μg/m3, a level already achieved at many DOE sites.10 (Interestingly, two DOE scientists have actually recommended 0.1 mg/m3 as a limit for occupational exposures.) The DOE rule only affects about 1600 workers, perhaps 5% of the beryllium-exposed workforce. Former DOE Secretary Bill Richardson has described the placing of nuclear workers at risk as “. . . one of the saddest chapters in [DOE’s] history.”
Other organizations have joined the chorus of those proclaiming beryllium’s dangers. The International Agency for Research on Cancer (IARC) has since 1993 regarded beryllium as a known human carcinogen, a link that has been confirmed. The National Institute for Occupational Safety and Health (NIOSH), a research arm of the government and part of the Centers for Disease Control and Prevention (CDC), has also criticized the current PEL, stating in comments to DOE in 1999 that “the current PEL of 2 μg/m3 has not eliminated chronic beryllium disease and sensitization to beryllium, and that disease has occurred in workers exposed to levels lower than the detection limit.”
In a May 2001 Federal Register Notice, OSHA indicated that it planned to issue a Notice of Proposed Rulemaking on Beryllium in December 2001. At that point, beryllium was designated as being in the Proposed Rule stage of rulemaking. Since then, beryllium has been relegated to the Prerule Stage, a status it has held in the past three OSHA Unified Agendas. This retrograde progress gives us little confidence that the agency is truly serious about adequately regulating this uniquely hazardous chemical.
Peter Lurie, M.D., M.P.H.
Public Citizen’s Health Research Group
Robert Horsch, M.P.H.
Sidney M. Wolfe, M.D.
Public Citizen’s Health Research Group
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