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2038. OCCUPATIONAL EXPOSURE TO TUBERCULOSIS
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: This action may affect the private sector under PL 104-4.
Legal Authority: 29 USC 655(b)
CFR Citation: 29 CFR 1910.1035
Legal Deadline: None
Abstract: On August 25, 1993, the Occupational Safety and Health Administration (OSHA) was petitioned by the Labor Coalition to Fight TB in the Workplace to initiate rulemaking for a permanent standard to protect workers against occupational transmission of tuberculosis (TB). Although the Centers for Disease Control and Prevention (CDC) have developed recommendations for controlling the spread of TB in several work settings (e.g., correctional institutions, health-care facilities, and homeless shelters), the petitioners stated that in every recent TB outbreak investigated by the CDC, noncompliance with CDC's TB control guidelines was evident. After reviewing the available information, OSHA preliminarily concluded that a significant risk of occupational transmission of TB exists for some workers and has accordingly issued a proposed rule. OSHA already regulates the exposure to the biological hazard of bloodborne pathogens (e.g., HIV, hepatitis B) under 29 CFR 1910.1030 and believes that development of a TB standard is consistent with the Agency's mission and previous activity. On October 17, 1997, OSHA published its proposed standard for occupational exposure to tuberculosis (62 FR 54160). The proposed rule covers workers in hospitals, nursing homes, hospices, correctional facilities, homeless shelters, and certain other work settings where workers are at significant risk of incurring TB infection while caring for their patients and clients or performing certain procedures. The proposed standard would require employers to protect TB-exposed employees by means of infection prevention and control measures that have been demonstrated to be highly effective in reducing or eliminating job- related TB infections. Such measures include procedures for early identification of individuals with infectious TB, isolation of individuals with infectious TB using appropriate ventilation, use of respiratory protection in certain situations, skin testing and training of employees with occupational exposure, and medical management and follow-up after exposure incidents or skin test conversions.
The written comment period ended on February 17, 1998. Subsequently, informal public hearings were held in Washington, DC (April 7-17), Los Angeles, CA (May 5-7), New York City, NY (May 19-21) and Chicago, IL (June 2-4). At the end of the hearings a post-hearing comment period was established. The deadline for final summation, briefs and written comments was October 5, 1998.
In addition to the public hearings, OSHA consulted with parties outside of the Agency with regard to the proposal. The preliminary Risk Assessment was peer-reviewed by four individuals with specific knowledge in the areas of tuberculosis and risk assessment. In addition, OSHA conducted stakeholder meetings with representatives of relevant professional organizations, trade associations, labor unions, and other groups. The proposal was also reviewed and commented on by affected small business entities under the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA). In addition, the draft proposed standard and preamble were reviewed by the Office of Management and Budget. OSHA is working on a final rule, which is expected in 2000.
OSHA will be reopening the rulemaking record for the limited purpose of placing a newly completed survey on homeless shelters, some new studies on respirator fit factors and another document in the record. The Agency will publish a notice in the Federal Register informing the public of the limited reopening and requesting public comment on the Agency submission.
Statement of Need: For centuries, TB has been responsible for the deaths of millions of people throughout the world. TB is a contagious disease caused by the bacterium Mycobacterium tuberculosis. Infection is generally acquired by the inhalation of airborne particles carrying the bacterium. These airborne particles, called droplet nuclei, can be generated when persons with pulmonary or laryngeal tuberculosis in the infectious state of the disease cough, sneeze, speak, or sing. In some individuals exposed to droplet nuclei, TB bacilli enter the alveoli and establish an infection. In most cases, the bacilli are contained by the individual's immune response. However, in some cases, the bacilli are not contained by the immune system and continue to grow and invade the tissue, leading to the progressive destruction of the organ involved. Although in most cases this organ is the lung (i.e., pulmonary tuberculosis), other organs outside of the lung may also be infected and become diseased (i.e., extrapulmonary tuberculosis).
From 1953, when active cases began to be reported in the United States, until 1984, the number of annual reported cases declined 74 percent, from 84,304 to 22,255. However, this steady decline in TB cases did not continue. Instead, from 1985 through 1992 the number of reported TB cases increased 20.1 percent. In 1992 more than 26,000 new cases of active TB were reported in the United States. In New York City alone, 3,700 cases of active TB were reported in 1991. While a decrease in active cases has been observed recently, there were still 19,851 reported cases in 1996. A large portion of the decrease occurred in high incidence areas where intervention efforts have been focused. However, over thirteen states showed an increase or no change in the number of reported cases in 1997. In addition, the factors that led to the recent resurgence of TB (e.g., increases in homelessness, HIV infection, immigration from countries with high rates of infection) still exist and the job duties of certain workers require them to be exposed to patients and clients with suspected or confirmed infectious TB. In addition, outbreaks of multidrug-resistant TB (MDR-TB) continue to occur. These strains of TB are resistant to several of the first- line anti-TB drugs. This multidrug-resistant TB (MDR-TB) is often fatal due to the difficulty of halting the progression of the disease. Individuals with MDR-TB often remain infectious for longer periods of time due to delays in diagnosing resistance patterns and initiating proper treatment. This lengthened period of infectiousness increases the risk that the organism will be transmitted to other persons coming in contact with such individuals.
Providing health care for individuals with TB increases the risk of occupational exposure among health care workers. In fact, several outbreaks of tuberculosis, including MDR-TB, have occurred in health care facilities, resulting in transmission to both patients and health care workers. CDC found that factors contributing to these outbreaks included delayed diagnosis of TB, delayed recognition of drug resistance, delayed initiation of effective therapy, delayed initiation and inadequate duration of TB isolation, inadequate ventilation in TB isolation rooms, lapses in TB isolation practices, inadequate precautions for cough-inducing procedures, and lack of adequate respiratory protection. CDC analyzed data from three of the health care facilities involved in the outbreaks, and determined that transmission of TB decreased significantly or ceased entirely in areas where recommended TB control measures were implemented. In addition, workers outside of health care may provide services to patient or client populations that have an increased rate of TB. For example, occupational transmission of TB has been documented in correctional facilities.
Summary of the Legal Basis: The legal basis for the proposed TB standard is a preliminary finding by the Secretary of Labor that workers in hospitals, nursing homes, hospices, correctional facilities, homeless shelters, and certain other work settings are at significant risk of incurring TB infection while caring for their patients and clients or performing certain procedures.
Alternatives: Prior to a decision to publish a proposal, OSHA considered a number of options, including whether or not to develop an emergency temporary standard, publish an advance notice of proposed rulemaking, or to enforce existing regulations.
Anticipated Costs and Benefits: Costs will be incurred by employers for engineering controls, respiratory protection, medical surveillance, training, exposure control, recordkeeping, and work practice controls. Benefits will include the prevention of occupationally-related TB transmissions and infections, and a corresponding reduced risk of exposure among the general population. OSHA estimates that more than 5 million workers are exposed to TB in the course of their work. The Agency estimates that the proposed provisions will result in an annual cost of 245 million dollars. Implementation of the standard is estimated to reduce the number of job-related cases of TB by 70-90 percent in the work settings covered, thus preventing approximately 21,400 to 25,800 work-related infections per year, 1,500 to 1,700 active cases of TB resulting from these infections, and 115 to 136 deaths resulting from these active cases.
Risks: From 1985 to 1992, the number of reported cases of TB in the U.S. increased, reversing a previous 30-year downward trend. While there has been a recent decrease in the reported number of cases of TB in the general population, a large part of this decrease can be attributed to focused intervention efforts in areas of high incidence of TB. Thirteen states showed an increase or no change in the number of reported TB cases in 1997, and the factors that contributed to the resurgence continue to exist along with exposure of certain workers to patient and client populations with an increased rate of TB. In addition, outbreaks of multidrug-resistant TB, a more fatal form of the disease, continue to occur. Therefore, employees in work settings such as health care or correctional facilities, who have contact with infectious individuals, are at high risk of occupational transmission. TB is a contagious disease spread by airborne particles known as droplet nuclei. Active disease can cause signs and symptoms such as fatigue, weight loss, fever, night sweats, loss of appetite, persistent cough, and shortness of breath, and may possibly result in serious respiratory illness or death.
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations
Government Levels Affected: State, Local, Tribal, Federal
Additional Information: During the rulemaking, OSHA met with small business stakeholders to discuss their concerns, and conducted an initial Regulatory Flexibility Analysis to identify any significant impacts on a substantial number of small entities. In addition, OSHA conducted a special study of homeless shelters and set aside certain hearing dates for persons who wished to testify on homeless shelter issues.
Agency Contact: Adam Finkel, Director, Health Standards Programs,
Department of Labor, Occupational Safety and Health Administration, 200
Constitution Avenue NW., Room N3718, FP Building, Washington, DC 20210
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