On July 2, 2003, the Agency for Toxic Substances and Disease Registry (ATSDR), a public health agency of the U.S. Department of Health and Human Services, issued for public comment a draft protocol for a beryllium exposure study proposed for Elmore, Ohio. The protocol outlines the proposed process for collecting samples as part of a study to determine levels of beryllium in homes and vehicles near Brush Wellman's Elmore plant, and that of a "comparison group" population in the Village of Ottawa, Putnam County, Ohio.
Brush Wellman joined interested stakeholders in responding to the ATSDR by submitting
18 pages of detailed comments and several supplementary documents. The Brush Wellman
comments express the company's concern with the appropriateness of ATSDR's study
approach, its proposed methods, and the meaningfulness and interpretability of its results.
While Brush Wellman is pleased to provide the full text of its comments to the media, government officials, neighbors and other interested persons in the community, it has summarized its extensive submittal to the ATSDR here for ease of review. Highlights of the Brush Wellman comments follow:
- The ATSDR has allowed the scope of this study to creep well beyond its defined mandate. The stated purpose for the study plan does not fulfill the original written request made by Senator Mike DeWine in 2001 nor does it meet the purpose as set forth by the ATSDR in its 2002 Health Consultation report for the Brush Wellman Elmore plant. The ATSDR 2002 report stated the following reason for performing this investigation:
"Ohio Senator Mike DeWine asked the Agency for Toxic Substance and Disease Registry (ATSDR) to investigate the potential for beryllium exposures from the Brush Wellman plant in Elmore, Ohio. Specifically, Senator DeWine asked whether beryllium air emissions from the plant and the possible off-site transport of beryllium dust on workers' clothing constitutes a health hazard to area residents."
The proposed testing protocol, as stated by the ATSDR in July 2003, is to determine if "higher-than-background exposures to beryllium occurring due to worker take-home or from past air emission deposition." This change in language significantly departs from Senator DeWine's request. In addition, the study protocol, as proposed, will not determine if a health hazard exists for the community, a central premise of the Senator's inquiry. The ATSDR concedes this fact on page 12 of the draft exposure study protocol where it states:
"The results of the soil and vacuum samples (concentration and loading) cannot be used to make a health determination for beryllium hypersensitivity or for chronic beryllium disease; there are no surface standards for this purpose. Since concentration and surface loading are important environmental parameters that are likely to be related to exposure and risk for disease, they will be reported and compared to expected background (comparison group) levels. A health-based ambient air standard exists for beryllium, measured as a 30-day average."
This limitation renders all of the proposed sampling useless for any interpretation of risk to the residents tested or the community at large, and undermines the relevancy and public health benefit of this costly, taxpayer-funded project.
- The agency's proposed statistically based action level is scientifically unsound. The ATSDR's statistical method guarantees at least 5% of the households tested - including those within the Village of Ottawa, Ohio comparison group - will be considered to have "elevated" levels of surface beryllium. The ATSDR's statistical method is illogical because the source of samples that will be used to define the "elevated" level is the soil from the comparison group in the Village of Ottawa. Beryllium is found naturally in soil in the Village of Ottawa, just as it is found naturally in soil everywhere throughout the United States.
- As agency officials have confirmed during public meetings, the creation of an arbitrary, so- called "elevated" value above the naturally occurring background level for beryllium in soil cannot be linked to any community health risk. In addition, ATSDR will be unable to determine if the source of any level of beryllium detected is naturally occurring or man-made.
- The U.S. EPA health-based standard is the only standard that exists for beryllium air emissions in a community. The standard is based on a 30-day sample taken monthly (more than 700 hours of continuous sampling). Brush Wellman is concerned with ATSDR's plan to take air samples for less than 3 hours at each residence - less than one half of one percent of the time specified by the EPA. The ATSDR's 3-hour air sample results will not be comparable to the EPA's 30-day health based standard, and thus are meaningless and not actionable from a public health standpoint.
- The Village of Ottawa, Ohio differs from Elmore, Ohio in important respects and it may not be an appropriate comparison site.
Beyond its technical shortcomings, the ATSDR's draft protocol is incomplete due to the absence of a detailed communications plan for the affected stakeholders of Ottawa and Putnam Counties and other interested parties.
Brush Wellman concluded the introductory section of its comments by suggesting that it is timely for the agency to re-gauge its work against the mandate it received to initiate the Elmore health consultation.
The ATSDR has already determined that beryllium emissions from the plant are below levels expected to cause adverse health effects and do not pose a public health hazard to residents. Brush Wellman has suggested that the agency should reassess whether spending unspecified resources and further time on this project represents a true service to public health and provides a prudent use of limited government funds. This is especially true since the ATSDR's July 2002 Health Consultation report recognized Brush Wellman's extensive efforts to prevent the "drag out" of beryllium particulate by workers since the 1950s.
The company has stated that if the proposed protocol cannot be revised to provide an accurate assessment of public health risk then the ATSDR should abandon the second phase of the study ("off-site transport of beryllium dust") as being infeasible.