It’s back: OSHA breathes new life into proposed tuberculosis standard
Agency reopens comment on risk assessment
Defying speculation that the proposed tuberculosis standard was all but dead, the U.S. Occupational Safety and Health Admini-stration (OSHA) announced it will reopen the rule for additional comment.
The action renews the sharp debate about how to best protect health care workers from a disease that is virtually nonexistent in some parts of the country and a real threat in others. Tuberculosis cases spiked in the early 1990s, and then declined steadily with the increased vigilance and use of new protections.
OSHA’s comment period, which ends March 25, is limited to the agency’s assessment of TB risk, one of the most contentious parts of the standard. This is the second time since the rule was proposed in 1997 that OSHA has reopened comment on the issue of risk assessment.
"There were significant concerns [about risk assessment] that OSHA never took into consideration in the final draft," asserts Jennifer Thomas, director of governmental affairs for the Washington, DC-based Association for Professionals in Infection Control. The organization has been a strong opponent of an OSHA TB standard.
OSHA is specifically soliciting comment on a National Academy of Sciences/Institute of Medicine (IOM) report, Tuberculosis in the Workplace, which was released in January 2001. (See HEH, March 2001, p. 31.)
While endorsing the concept of a TB standard to set minimum protections for health care workers, the IOM panel criticized aspects of OSHA’s proposed rule.1 The proposed standard fails to provide enough flexibility to hospitals at low-risk and relies on outdated and flawed estimates of the tuberculosis threat, the IOM panel said.
For the first time, OSHA also has released a copy of the quantitative risk assessment used to determine the level of TB risk nationwide, as well as comments by two expert reviewers. (For more information, see editor’s note at the end of this article.)
If this OSHA action means the agency is closer to releasing a final rule, that comes as welcome news to some employee health professionals who are seeking clarification on TB-related requirements. Larry Lindesmith, MD, FACOEM, FCCP, medical director of employee health and safety at Gundersen Lutheran Medical Center in La Crosse, WI, notes that there are conflicts in existing rules and guidelines on respirator fit-testing and TB screening. "[The IOM report] did lend credence to the fact that we still need a standard."
The risk of TB transmission varies widely around the country, and it is this variation that complicates TB regulation.
In its draft risk assessment, OSHA notes that "Data to estimate the occupational risk of TB infection are limited." OSHA uses studies at Jackson Memorial Hospital in Miami and Grady Memorial Hospital in Atlanta as examples of "very high" TB exposure sites, Washington state as an example of a low TB prevalence site, and national voluntary surveys to calculate "average exposure" rates. OSHA also reviewed published literature and TB studies submitted in previous comment periods.
One reviewer, Richard Menzies, MD, director of the respiratory epidemiology unit at McGill University in Montreal, wrote that "[I]t is reasonable to tailor the measures needed according to level of risk. However, there is no method presently available to reliably estimate risk of nosocomial transmission of TB within hospitals.
"There is sufficient evidence to conclude there is a real risk of occupational TB infection, so OSHA and other regulatory agencies have a duty to act," he added. "However, the agencies also have a duty to acknowledge the limitations of the current evidence in order to encourage further investigation where it is most needed, and to allow for future revision when new evidence is available."
The latest science and epidemiology will be reflected in TB guidelines currently under revision by the Centers for Disease Control and Prevention (CDC) in Atlanta. The CDC defines five levels of TB risk, from minimal to high, and provides different recommendations based on risk level.2
OSHA has provided feedback on the draft revisions, says Amanda Edens, project officer for OSHA’s TB rulemaking. OSHA also has expressed a willingness to modify the risk-based requirements in the proposed TB standard to match those of the CDC, she says. For example, in the minimal and very-low risk categories, the CDC does not recommend periodic skin testing for most health care workers. "We’ve always tried to make [OSHA standards and CDC guidelines] parallel, as much as possible," she says.
Despite the reopening of the rule for comment, it still isn’t clear when, or if, there will be a final TB standard.
Edens notes that OSHA administrator John L. Henshaw will make that ultimate determination. Meanwhile, if a TB hazard is identified at a facility, OSHA would cite the employer under the "general duty" clause. "Where we find a hazard exists, we will look to the 1994 CDC guidelines to figure out what is a feasible means of abatement,’" she says. "A standard is much more clear; it’s much more proactive. It lets employers and workers know exactly what’s required of them."
Whatever OSHA does, it should provide hospitals with flexibility on issues such as skin testing, says Geoff Kelafant, MD, MSPH, FACOEM, medical director of the occupational health department at the Sarah Bush Lincoln Health Center in Mattoon, IL, and chairman of the medical center occupational health section of the American College of Occupational and Environmental Medicine, based in Arlington Heights, IL.
"It’s a significant amount of work for most institutions to have to do the screening every year," he says. "[In the proposed TB standard], I think there wasn’t sufficient latitude for local decision making and to take local conditions into consideration."
[Editor’s note: A copy of the Federal Register notice is available at www.osha-slc.gov/FedReg_osha_data/FED20020124.html. OSHA is asking for two copies of written comments to be sent to: Docket Office, Docket H-371, Room N-2625, Occupational Safety and Health Administration, U.S. Department of Labor, 200 Constitution Ave., N.W., Washington, DC 20210. Comments of 10 pages or fewer may be sent by FAX to: (202) 693-1648, provided that the original and one copy of the comments are sent to the Docket Office immediately thereafter. Comments also may be sent electronically to http://ecomments.osha.gov. Copies of the risk assessment and reviewers’ comments (Docket H-371) are available at the Docket Office, (202) 693-2350.]
References
1. National Academy of Sciences/Institute of Medicine. Tuberculosis in the Workplace. Washington, DC; Jan. 16, 2002. Web site: www.iom.edu.
2. Centers for Disease Control and Prevention. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care facilities, 1994. MMWR 1994; 43(No. RR-13):1-133.
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