OSHA’s proposed standard draws fire from supporters and detractors
More hearings and input could further delay a final rule
The proposed tuberculosis standard from the Occupational Safety and Health Administration (OSHA) has taken four years to cobble together, and one thing supporters and opponents agree on is that it has taken too long. Supporters say the lengthy process questions OSHA’s ability to respond quickly to employee health threats. Opponents say the TB picture in the United States has changed so much in the past four years that the standard is no longer necessary. And OSHA itself is seeking more input before making any final decisions.
"This was supposed to be a fast-track standard, and it calls into question the entire rule-making process and whether workers can rely on OSHA to regulate the most basic and largest hazards they face," says Bill Borwegen, health and safety director of the Services Employee International Union (SEIU) in Washington, DC.
The SEIU and other unions petitioned OSHA to develop a TB standard in 1993 after TB rates had risen steadily and alarming reports arose about occupational TB exposures from multi-drug resistant outbreaks. Even though TB rates have been declining for four years in the United States, Secretary of Labor Alexis Herman notes that even though cases of multidrug-resistant TB have decreased, new and deadly forms have been reported now in most states.
"The battle against TB is far from over," she says. "While the rate of active TB in the general population has declined overall during the past 40 years, the risk for the workers who care for clients and patients infected with TB continues to be high, and in some cases, is growing."
The proposed standard is estimated to help protect 5.3 million workers in hospitals, homeless shelters, long-term care facilities for the elderly, detention facilities, certain laboratories, and other work settings at high risk of TB infection. OSHA estimates the standard could eliminate 70% to 90% of work-related TB infections and save $89 million to $116 million a year in medical costs for treatment and lost production time.
OSHA’s standard tracks closely with the updated TB prevention and control guidelines issued by the Centers for Disease Control and Prevention (CDC) in 1994. Unlike the voluntary CDC guidelines, however, the OSHA standard is enforceable, and facilities can be fined for violations.
OSHA has incorporated the basic elements of the CDC recommendations written exposure control plans, procedures for early identification of suspected cases, procedures for investigating employee skin test conversion, and employee education and training.
"It seems that they do follow the CDC more than I thought they would," says Lee Reichman, MD, MPH, director of the National Tuberculosis Center in Newark, NJ, and spokesman for the American Lung Association in New York. "It shows they are responding to the fact that these standards should be scientifically, rather than politically, based."
As with the CDC guidelines, the standard would require employers to develop written exposure control plans and either to identify and isolate people with TB or to transfer them to facilities with isolation capabilities. In addition, the standard requires engineering controls, including negative pressure isolation rooms in high-risk facilities, tuberculin skin testing, hazard communication, training, and record keeping.
In keeping with CDC recommendations, the OSHA standard will allow facilities to use the new N-95 respirators approved by the National Institute of Occupational Safety and Health. It will also require both respirator fit testing and fit checking, according to experts who have seen earlier drafts of the full document.
"The proposed standard would allow the use of low-cost respirators that can be used multiple times," says Greg Watchman, OSHA’s acting assistant secretary. "We believe that, in combination with other controls, respirators are effective in preventing TB transmission."
The OSHA standard, however, expands its reach beyond the CDC guidelines, covering not only hospitals, correctional facilities, homeless shelters, and long-term care facilities for the elderly but also hospice facilities, drug treatment centers, high-hazard laboratories, emergency medical services, home health care, and home-based hospice care.
The standard also would cover occupational exposures to workers involved in social work, social welfare services, teaching, law enforcement, or legal work if those services are provided in those settings or in residences where people are being segregated or confined for suspected or confirmed infectious TB.
Employers in facilities located in counties at low risk of TB infection would be exempt from some of the requirements. While those facilities would be required to prepare a written exposure control plan, provide baseline skin tests, and be able to manage an exposure incident, they would not have to undertake periodic medical surveillance and respiratory protection.
A more limited program would apply to facilities that meet the following criteria similar to the CDC guidelines:
• doesn’t admit or provide medical services to people with suspected or confirmed TB;
• has had no case of confirmed infectious TB in the past 12 months;
• is located in a county that, in the past two years, had reported no cases of confirmed infectious TB in one year and fewer than six cases of confirmed TB reported in the other year.
OSHA estimates that implementing the standard will cost about $2,400 per facility, a burden that may be difficult for smaller businesses and homeless shelters to carry, say critics of the standard. OSHA officials say they have contracted for a special study on how to implement the requirements in homeless shelters. (For OSHA estimates of the economic impact on affected entities, see chart, p. 125.)
The OSHA standard differs from the CDC guidelines in several other areas. It requires employers to conduct an exposure assessment rather than a site-specific risk assessment. The CDC guidelines recommend that local TB control programs take into account TB prevalence at their facilities as well as in their counties, whereas the OSHA standard requires assessment for the county alone. Also, the standard’s medical surveillance requirements require six-month skin testing in some instances compared with the annual skin-testing requirement by the CDC. And it requires respirator use in some situations not addressed by the CDC.
Having already received widespread, and sometimes critical, input from stakeholder group meetings, OSHA officials expect broad participation in a series of public hearings on the standard scheduled to begin in February 1998. In its proposal, which was published in the Oct. 17 issue of the Federal Register, OSHA lists dozens of questions and issues it wants input on. With an estimated 100,000 facilities impacted by the standard, the public hearings are expected to generate heated discussion and further delay a final rule. (For a breakdown of estimated cost per industry, see chart, above.)
Members of the coalition of labor unions who petitioned for the standard were generally supportive of the proposal. Jordan Barab, director of safety and health for the American Federation of State, County, and Municipal Employees in Washington, DC, also criticizes OSHA’s dilatory response.
The union has two areas of concern about the proposal. One is that coverage of social service workers appears to be limited to those who work in or serve high-risk settings, making it too limited, Barab says. The other concern is how risk assessments of local areas will be reported to facilities so they will know at what level they must comply.
"How that information is communicated is something that is of concern to us," Barab notes, "because how else does someone know if they should comply."
SEIU’s Borwegen questions why the agency was meeting again with stakeholders in October, four months before it is scheduled to hold public hearings. "Everyone in the whole world has already weighed in on it," he says. "My question is how many nurses have they met with, and I can tell you the answer is zero unless [you count] ones that work with industry lobby groups."
Several infection control organizations have opposed the standard, arguing that its cost in dollars and time is unwarranted, considering TB rates in the United States are lower now than anytime since the CDC began gathering detailed rates in 1953.
"The success of that document [the 1994 CDC guidelines] is amazing, so why do we need additional things?" asks Eddie Hedrick, MT, CIC, chairman of the TB committee for the Associa- tion for Professionals in Infection Control and Epidemiology (APIC). "The data OSHA presents in its press release is very dramatic, that it will prevent 130 deaths. But I’m not sure that is accurate. In all my years, I can’t think of an [HIV-negative] health care worker dying of TB."
APIC questions the need for several of the standard’s proposals, such as the need for annual fit-testing of respirators, says Hedrick. "APIC’s not sure we need a respiratory protection program with fit-testing for these kinds of respirators [N-95]," he elaborates. "We think fit-checking makes more sense than fit-testing. . . . Taking 2,000 people and fit-testing them is extremely expensive."
Although the final draft appears nearly identical to one OSHA presented to stakeholders nearly three years ago, Hedrick still is optimistic that a groundswell of public opinion could result in substantial changes in the document.
"Because OSHA was petitioned to do this, they feel they have to go forward," he says, "but many of us would have liked them to have simply taken the CDC document and enforced it."
The need to enforce the CDC guidelines is as apparent to OSHA as it is to union officials. The agency estimates that only about half of all hospitals voluntarily comply with the CDC’s current TB guidelines, and even fewer facilities in other occupational settings follow the recommendations.
Indeed, Borwegen argues that the health care providers will benefit from having an enforced standard just as they have with OSHA’s bloodborne pathogen standard, which evoked strong criticism at first.
"Whether they understand it or not, they would benefit from this standard just as with the bloodborne pathogen standard, which gave them resources to deal with that problem," he adds.
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