- Email: [email protected]
Enforcement policies and procedures for occupational exposure to tuberculosis
Occupational Safety and Health Administration U.S. Department
of Labor
This memorandum provides clarification for OSHA-wide enforcement policy and procedures for inspections concerning occupational exposure to tuberculosis (TB) for the private sector as well as Federal agencies. The policy set forth in this memorandum is effective immediately, with the exception of the requirements for the appropriate minimum level of respiratory protection which will be enforced ninety (90) days from this memorandum’s date of issuance. In response to employee complaints about occupational exposure to TB, OSHA has conducted inspections and issued citations where appropriate. The Directorate of Compliance Programs, with the assistance of the Directorate of Technical Support and OSHA Region II, is drafting a compliance directive providing enforcement guidance on occupational exposure to TB. This compliance directive will be based on the Centers for Disease Control and Prevention (CDC) final revision of their 1990 guidelines for preventing the transmission of tuberculosis in health care settings which is expected to be published in the coming year. The following agency-wide enforcement guidance is provided pending the issuance of the compliance directive and is based on the CDC’s current recommendations. Regional Administrators shall provide a copy of this memorandum to State plan designees and the designees shall advise the Regional Administrator of their intent regarding the State’s enforcement policy within thirty days of receipt of this memorandum. In the interest of providing consistently effective employee protection nationwide, State
This document is an OSHA memorandum for Regional Administrators from the Directorate of Compliance Programs, issued Oct. 8,1993. Attachment A, “Guidelines for Preventing the Transmission of Tuberculosis in Health-Care Settings, with Special Focus on HIV-Related Issues,” is not reprinted here but is available in the Centers for Disease Control and Prevention MorbicCyandMortaMy Week/yReport (MMWR 1990;38[RR-17]:1-28).
plan states are expected to implement enforcement policies and procedures for inspections concerning occupational exposure to TB as set forth in this memorandum, or to develop their own alternative enforcement program including extension of coverage to State and local government employees. Virtually all State plan states have in place a statutory requirement parallel to the general duty provision of section 5(a)(l) of the Occupational Safety and Health Act of 1970, which is a major aspect of federal OSHA’s TB enforcement policy. While section 18 of the Act does not require specifically that States adopt the S(a)(l) provision, the States are strongly encouraged to enforce their existing general duty requirements in a manner consistent with the Federal policy. In accordance with Executive Order 12 196, Section l-201, and 29 CFR 1960.16, Federal agencies must also follow the enforcement policy and procedures on TB contained in this document. BADKGROUND
Since 1985, the rate of new cases of TB in the general U.S. population has increased 18 percent, reversing a 30-year downward trend. In 1990, 25,500 new cases of TB were reported in the U.S. In New York City alone 3700 cases of TB were reported in 199 1. Recently, drug resistant strains of Mycobacterium tuberculosis have become a serious concern and cases of multi-drug resistant (MDR-TB) have occurred in forty states. In a recent New York City study, 33% of cases had organisms resistant to at least one drug, and 19% had organisms resistant to the two most effective drugs available for treating the disease. When organisms are resistant to both drugs the course of treatment increases from six months to 18-24 months, and the cure rate decreases from 100% to 60% or less. Since 1988, outbreaks of TB, including a multidrug resistant strain, have occurred at hospitals in 31A
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Atlanta, Miami, New York City, and New Jersey. In outbreaks at seven hospitals and one prison that the CDC have investigated, 16 health care workers have developed active multi-drug resistant TB (MDR-TB). At least five health care workers have died. Nationwide, at least several hundred employees have become infected after workplace exposure to TB and have required medical treatment. Approximately ten percent of normally healthy people who are infected will develop active TB disease within their lifetime. M. tuberculosis is carried through the air in infectious droplet nuclei of 1 to 5 microns in size. These droplet nuclei may be generated when a person with infectious TB disease coughs, speaks, sings, or spits. In an occupational setting, workers in close contact with persons with infectious tuberculosis disease are at increased risk of infection with TB. Certain high hazard medical procedures which are cough-inducing may further increase the risk of infection of health care workers. The employer’s responsibilities are set forth in the Occupational Safety and Health Act of 1970. However, in December 1990 the CDC published the “Guidelines for Preventing the Transmission of Tuberculosis in Health-Care Settings, with Special Focus on HIV-Related Issues” in its Morbidity and Mortality Weekly report (MMWRAttachment A). This document outlined general principles of TB control and the CDC’s specific recommendations including the hierarchy of controls to be implemented (e.g., early identification, isolation, medical surveillance, personal protective equipment). OSHA is relying on these guidelines as reflecting a widely recognized and accepted standard of protection to be followed by employers in carrying out their responsibilities under the OSH Act. The compliance procedures contained in this memorandum are also consistent with the agency’s traditional hierarchy of controls and good industrial hygiene practice which dictate that engineering controls be used wherever possible to eliminate or reduce the hazard at its source. When it is not possible to prevent employee exposure to the hazard, other measures such as administrative or work practice controls must be employed. Lastly, personal protective equipment shall be used to protect the employee. In May 1992, Region II, in conjunction with the New York State Public Employee Safety and Health Program and OSHA’s National Office, developed and issued “Enforcement Guidelines
for Occupational Exposure to Tuberculosis” in response to the increasing number of complaints received in area offices from health care workers occupationally exposed to TB. The purpose of the document was to provide compliance officers with guidance about how to protect themselves during TB-related inspections, and to outline the region’s enforcement requirements for such facilities. The Region II guidelines were based on the CDC 1990 “Guidelines for Preventing the Transmission of Tuberculosis in Health Care Settings with Special Focus on HIV-Related Issues” (Attachment A). Approximately 30 inspections of workplaces have been conducted nationwide. These inspections reveal that employers have not fully implemented the current CDC guidelines. INSPECTION
GUIDANCE
Inspections for occupational exposure to TB shall be conducted only in response to employee complaints or as part of all industrial hygiene compliance inspections conducted in workplaces where CDC has identified workers as having a greater incidence of TB infection. These workplaces have been the subject of reports issued by CDC which provide recommendations for the control of TB. Specifically, these workplaces are as follows: 1. health care settings’ 2. correctional institutions 3. homeless shelters 4. long-term care facilities for the elderly 5. drug treatment centers Complaints received from state and local government employees who are outside federal jurisdiction in Federal enforcement states shall be forwarded to the Regional Office for referral to the appropriate state agency. RECORDlNG
IN THE MIS
A TB-related inspection is any health inspection conducted for the purpose of investigating the presence or alleged presence of TB disease (i.e., a referral or complaint inspection) or any health inspection which results in a TB-related citation. When a TB inspection is conducted, as defined above, the OSHA-1 shall be completed as for any inspection. The code “N 02 TB” shall be entered in Item 42, Optional Information. All IMIS case file data for TB-related inspections conducted since October 1, 1990, shall be modified to include the appropriate TB code. 1. See MMWR, Attachment A, pg. 2.
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OFFICER PROTECTION
When responding to TB-related complaints, compliance officers are to take the following additional precautions: 1. Compliance officers shall not enter occupied isolation rooms to evaluate compliance. 2. Compliance
officers shall not enter work areas while high hazard procedures, such as aerosolized administration of medication, bronchoscopy, and diagnostic sputum induction, are being conducted.
3. When entry into potentially
hazardous areas is judged necessary, compliance officers shall be properly equipped as required by the facility as well as by their own professional judgment, after consultation with the supervisor. At a minimum, this shall include the use of a NIOSH-approved respirator equipped with high efficiency particulate air (HEPA) filters.
CITAWON DUIDANCE Eectton S(a)(l) - Deneral
Duty Clause
2. A suspected
exposure to the exhaled air of an with suspected2 or confirmed TB case
is one
in which
the facility
has
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2. Exposure to a high hazard procedure performed on an individual with suspected or confirmed TB disease and which has the potential to generate potentially infectious airborne respiratory secretions. Examples of high hazard procedures include aerosolized medication treatment, bronchoscopy, sputum induction, endotracheal intubation and suctioning procedures, and autopsies. Note that the hazard, not the absence of a particular means of abatement, is the basis for the general duty clause citation. All applicable abatement methods identified as correcting the same hazard shall be issued under a single 5(a)(l) citation. The following are examples of feasible and useful abatement methods. Failure to use any of these methods may result in the continued existence of a serious hazard and may, therefore, allow citation under 5(a)(l): 1. Protocol for the early identification uals with active tuberculosis.
of individ-
2. Medical
Occupational exposure to TB is a serious and recognized hazard and certain feasible abatement methods exist. Therefore, application of section 5(a)(l) of the OSH Act is warranted. Section 5(a)(l) citations must meet the requirements outlined in the FOM, Chapter IV, and may be issued where there is a hazard which cannot be abated by compliance with a specific OSHA standard. Industry recognition for purposes of citing section 5(a)(l) is recognition of the hazard of being infected with tuberculosis through the exposures detailed below. The workplaces under discussion (see Inspection Guidance) generally recognize the determination of this hazard by the CDC which is the acknowledged authority in this area. The employer’s TB program or generic infection control program can also constitute evidence of knowledge and recognition. Citations shall be issued only to employers whose employees work in one of the five types of facilities whose workers have been identified by the CDC as having a higher incidence of TB than the general population (see Inspection Guidance) and whose employees have exposure defined as follows: 1. Potential individual disease.
information
identified
an
surveillance (at no cost to employees) including preplacement evaluation, administration and interpretation of TB Mantoux skin tests, and periodic evaluations shall be offered to employees as follows: an initial baseline screening at the time of employment for all employees in the covered facilities; annually for all employees in the covered facilities; retesting every six months for workers with exposure as defined above (see MMWR pp. 1% 19, Attachment A).
3. Evaluation
and management (at no cost to employees) of workers with a positive skin test, or with skin test conversion on repeat testing, or who are exhibiting symptoms of TB, including work restrictions for infectious employees. Workers who experience a TB exposure incident (exposure to a patient/client with infectious TB for whom infection control precautions have not been taken) shall also be managed according to CDC recommendations (see MMWR p. 19, Attachment A). 4. Placement of individuals with suspected or confirmed TB disease in an AFB (acid fast bacilli) isolation room. AFB isolation rooms for persons with suspected or confirmed infectious TB and areas in which high hazard procedures individual as having symptoms consistent with TB. The CDC has identified the symptoms to be: productive cough, coughing up blood, weight loss, loss of appetite, lethargy/weakness, night sweats, or fever.
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are performed on such individuals must be maintained under negative pressure and appropriately exhausted (either directly to the outside away from intake vents or through properly designed, installed, and maintained HEPA filters). [Note that at the present time, the effectiveness of certain other engineering controls (such as local exhaust and UV lights) is being evaluated. However, given the serious nature of the TB hazard and the fact that such engineering controls may reduce the hazard to some degree, the compliance officer shall strongly encourage the employer to follow the CDC guidelines in the areas of local exhaust and UV lights.] 5. Training and information to ensure employee knowledge of such issues as the hazard of TB transmission, its signs and symptoms, medical surveillance and therapy, and site-specific protocols including the purpose and proper use of controls. (Note that failure to provide respiratory protection training is citable under 1910.134). If a citation is justified under 5(a)(l), the citation shall, after setting forth the SAVE for section 5(a)(l), state: “Workers [specify job classifications such as doctors, nurses, prison guards, etc.] [specify location] were exposed to the hazard of being infected with tuberculosis through contact with [specify group such as patients, inmates, clients, etc.] who were or may be infected with tuberculosis in that: [list exposure as detailed above]. Feasible and useful abatement methods for reducing this hazard, as recommended by the Centers for Disease Control, among others are: [list abatement methods as detailed above]. ” 29 CFR 1910.134-Respiratory
Protection:
The CDC’s 1990 Guidelines recommend that employees wear particulate respirators in the following circumstances: 1. When employees enter rooms housing individuals with suspected or confirmed infectious TB disease. 2. When employees perform high hazard procedures on individuals who have suspected or confirmed TB disease. Examples of high hazard procedures include aerosolized medication (e.g., pentamidine) treatment, bronchoscopy,
sputum induction, endotracheal intubation suctioning procedures, and autopsies.
and
3. When emergency-medical-response personnel or others must transport, in a closed vehicle, an individual with suspected or confirmed TB disease. In the above circumstances, employers must provide and ensure the use of NIOSH-approved high efficiency particulate air (HEPA) particulate respirators as the minimum acceptable level of respiratory protection. See Attachment B on Respirator Selection Logic for details. If a facility chooses to use disposable respirators as part of their respiratory protection program, their reuse is permitted as long as the respirator maintains its structural and functional integrity. The facility shall address the circumstances in which a disposable respirator will be considered to be contaminated and not available for reuse. Compliance officers shall cite 29 CFR 19 10.134 (a)(2), which requires that respirators be provided when necessary to protect employee health and that the respirators be suitable for the purpose intended, when less protective or no respiratory protection is provided. Whenever respirators (including disposables) are required to be used, a complete respiratory protection program must be in place in accordance with 29 CFR 1910.134(b). If a citation is warranted under 19 10.134, the following SAVE language may be used: “The employer did not provide respirators which were applicable and suitable for the purpose intended, nor was a respiratory protection program established which included the requirements outlined in 29 CFR 1910.134(b).” The following AVD shall be used when 1910.134(a)(2) is cited: (a) Employees were given a [LIST MANUFACTURER/MODEL NUMBER] mask for protection against airborne Mycobacferitlm ruberculosis. They should be using at least NIOSH-approved HEPA particulate respirators. NIOSH-approved respirators providing greater protection would also be acceptable.” 29 CFR 1910.143-Accident and Tags:
Prevention
Signs
In accordance in 1910.145(f)(8), a warning shall be posted outside the AFB isolation room.
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1910.145(f)(4) requires that a signal word be presented as well as a major message (e.g., “special respiratory isolation”, “AFB isolation”) or a description of the necessary precautions. 29 CFR 1910.29-Access Exposure and MedIcal
to Employee Records:
A record concerning employee exposure to TB is an employee exposure record within the meaning of 29 CFR 19 10.20. A record of TB skin testing results and medical evaluations and treatment is an employee medical record within the meaning 19 10.20. These records shall be handled according to 29 CFR 1913.10 so that the compliance officer may determine compliance with 29 CFR 1910.20. 29 CFR 1994-Lqj and Summary of Occupational Infuries and Illnessas:
TB infections (positive TB Mantoux skin test) and TB disease are both recordable on the OSHA 200 log in the above-referenced high risk settings. A positive skin test for TB, even on baseline testing (except pre-employment screening), is recordable on the OSHA 200 log because there is a presumption of work-relatedness in these settings. Federal agency recordkeeping requirements are outlined in Part 1960 Program Elements, Subpart I, and in “Recordkeeping and Reporting Guidelines for Federal Agencies” (OSHA publication 2014). If an employee’s TB infection which has been entered on the OSHA 200 log progresses to TB disease during the five year maintenance period, the original entry for the infection shall be updated to reflect the new information. Because it is clinically difficult to determine if TB disease resulted from the source indicated by the skin test conversion or from subsequent exposures, only one case should be entered to avoid double counting. CITATION
REVIEW
Until further notice, all citations proposed under these guidelines shall be reviewed prior to issuance at the Regional Office level. Where necessary for proposed 5(a)( 1) and 1910.134 citations, the regional office shall contact the Directorate of Technical Support for coordination of expert testimony. AGENCY OUTREACH AND ASSISTANCE
The agency recognizes the need for a national outreach effort and is currently planning the
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coordination of such an effort. In addition, the Regional and Area Offices are strongly encouraged, to the extent permissible by resources, to work with local institutions and associations representing affected facilities in an educational and outreach effort. ATTACHMENT 6: RESPIRA’TOR SELECTtON LODlC*
OSHA has identified the appropriate minimum level of respiratory protection for occupational exposure to TB, based on the following best available information regarding the characteristics of exposure and the feasibility of compliance: l
l
The minimum respiratory protection is a NIOSH-approved high-efficiency particulate air (HEPA) particulate respirator. The employer must establish and implement a respiratory protection program in accordance with the requirements of OSHA’s respiratory protection standard, 29 CFR 1910.134.
In making the selection of respirators for protection against TB, it was necessary to consider factors which affect the performance of respirators such as filter performance, face seal leakage and fit check. These factors are as follows: FACTOR # 1: Identification and selection rationale of the appropriate minimum level of respiratory protection for occupational exposure to TB.
Engineering controls must be implemented to reduce the risk of exposure to TB. The selection of respirators to supplement engineering controls, is usually based on the permissible exposure limit for the air contaminant in question. There is no known safe exposure level for TB. Therefore, it is prudent to select respirators which would provide minimal margin of error since each additional inhaled TB bacillus may increase the risk of disease. The nature of work in connection with TB patients is a critical factor that must be kept in mind in selecting appropriate respirators for exposure to TB. Respiratory protection requirements will be modified later if a threshold for TB exposure is established. Since there is no established safe exposure level for TB, NIOSH recommends that hospitals use powered air-purifying respirators (PAPRs) as the *Attachment A, “Guidelines for Preventing the Transmission of Tuberculosis in Health-Care Settings, with Special Focus on HIV-Related Issues,” is not reprinted here but is available in the Centers for Disease Control and Prevention MorbidityandMorfality Week/y Report (MMWR 1990;38[RR-17]:1-28).
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minimum level of respiratory protection for exposure to TB. OSHA, however, recognizes that PAPRs may interfere with patient care, or could be infeasible for other reasons. Therefore, OSHA does not require the use of PAPRs as the minimum level of acceptable respiratory protection. Based on the best currently available information on respirator filters and respirator characteristics, OSHA requires the use of a NIOSH-approved HEPA particulate respirator for workers in TB patient isolation rooms, during high hazard procedures, and involved in medical transport in closed vehicles as the minimum level of protection. In order to minimize the exposure to TB, effective fit tests and fit checks must be performed. Quantitative or qualitative fit testing must be performed for each respirator wearer. The quantitative fit testing (QNFT) is the most reliable fit testing method. (OSHA has accepted several qualitative fit testing [QLFTJ agents such as isoamyl acetate, irritant fume and sodium saccharin. The mass median aerodynamic diameter for the saccharin aerosol is 3 wrn and the irritant fume is in the submicrometer size range. The irritant fume QLFT is considered to be the more reliable test agent since the saccharin QLFT is dependent on the subjective response of the test subject to the taste of the saccharin mist while the irritant fume QLFT elicits the test subject’s involuntary response to the fume.) Appendix C of the asbestos standard, 29 CFR 1910.1001, should be used as a guide for performing fit testing. It should be noted that some molded fabric type respirators are valveless or have an exhalation valve which cannot be blocked by the hand. An effective fit check may be difficult to perform on these respirators. In these cases, fit checks should be done according to manufacturers’ instructions. FACTOR #2: The filtration characteristics and filtration efficiencies of the different types of particulate respirators, e.g. Dust/Mist, Dust/Fume/Mist, and HEPA. Comparison and clarification about the significance of the size of the challenge particulate, the mean aerodynamic diameter of the challenge particulate, and whether the filtration efficiency is dependent on filter loading.
The OSHA standards on respiratory protection, 29 CFR 1910.134, and air contaminants, 29 CFR 1910. lOXX, require the use of respirators which are jointly approved by the Mine Safety and Health Administration (MSHA) and the National Institute for Occupational Safety and Health (NIOSH) under the provisions of 30 CFR Part 11. The test
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methods for air-purifying respirators equipped with particulate filters are prescribed in 30 CFR Part 11. Schedule K, which includes performance tests for single use, dust/mist, fume and HEPA filters. A discussion of different filter testing methods appears under Factor # 3. NIOSH’s dust filter certification test requires a challenge of a very high concentration (50 milligrams per cubic meter) of silica dust, and an integrated penetration is the only required measurement at the end of a 90 minute test. The integrated measurement method permits the use of less efficient filter media which allow the penetration of fine particles until a cake is built upon the respirator filter surface (filter “loading”). This in turn decreases the penetration of particles, and meets the integrated penetration requirement. This type of measurement also applies to the dust/mist/fume filter. CDC3 states that the size of the droplet nuclei carrying the TB bacilli is between l-5 pm. There is no assurance that the MSHA/NIOSH approved dust/mist or dust/mist/fume filters classified in accordance with the current certification methods would remove airborne droplet nuclei containing the TB bacteria. Furthermore, the certification tests for dust/mist and dust/mist/fume filters do not evaluate initial filter efficiency. Respirators with HEPA filters are the only currently available certified respirators that meet or exceed the required filter efficacy against low-concentration aerosols in the size range of droplet nuclei. MSHA/NIOSH-approved HEPA filters are effective against all sizes of particles (including the 1 to 5 pm range) upon first donning (without dependence on filter loading). In addition, every HEPA filter must be verified by the manufacturer for meeting the di-2-ethylhexyl phthalate (DOP) penetration requirement described below. FACTOR #3: The NIOSH evaluation methods for the different types of particulate respirators.
The NIOSH evaluation method is detailed in schedule K of 30 CFR Part 11. An overview of Schedule K is as follows: Different test schedules are listed in 30 CFR Part 11 for approval of different classes of respirators. The test method for air-purifying respirators 3. NIOSH Recommended Guidelines for Personal Respiratory Protection of Workers in Health-Care Facilities Potentially Exposed to Tuberculosis. Atlanta, Georgia: U.S. Department of Health and Human Services, Public Health Service, 1992.
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equipped with particulate filters are prescribed in Schedule K of this part. It includes performance tests for single use, dust/mist, dust/mist/fume, and HEPA filters. Usually, a respirator which receives the high-efficiency approval also includes the fume, dust and mist approvals. The fume approval also includes the approval for dust and mist. The dust approval also includes the approval for mist. Three types of aerosols, silica, lead fume, and di-2-ethylhexyl phthalate, have been used for certifying particulate respirators. Polydisperse silica dust having a projected particle diameter of 0.4 to 0.6 micrometers (measured by a microscope) is used for testing dust and single use filters. The test is performed inside a dust chamber at a concentration between 50 to 60 milligrams per cubic meter. The temperature is approximately 25” C and the relative humidity may vary from 20% to 80%. The test period is 90 minutes at a flow rate of 32 liters per minute for non-powered respirators. The flow rate for tight and loose fitting inlet covering powered air-purifying respirators (PAPR) is 115 liters (4 cubic feet) per minute and 170 liters (6 cubic feet) per minute respectively, and the test period for the PAPR’s is 4 hours. Since single use respirators are valveless, the filter performance test is performed on a breathing machine at a rate of 24 respirations per minute with a minute volume of 40 liters per minute. When the filters are placed in pairs or in triplets, the air flow to each filter element will be reduced accordingly. For example, if two filter elements are used on a twin cartridge respirator, the air flow to each filter will be half of 32 lpm or 16 lpm. The maximum allowable filter penetration is 1% for all filters listed in Subpart K, except for the HEPA filter which is 0.03%. The performance test requirements for the polydisperse silica mist is similar to the test for silica dust, except that an aqueous suspension of silica at a concentration between 20 and 25 milligrams per cubic meter replaces the silica
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dust, and also the test time for the non-powered respirator is 3 12 minutes. The polydisperse lead fume test is performed in a test chamber with freshly generated lead oxide fumes at a concentration from 15 to 20 milligrams of Pb per cubic meter of air. Other test conditions, including air flow, are the same as the silica dust test except that the test period is 3 12 minutes for non powered, and 4 hours for powered respirators. The maximum allowable filter penetration is 1%. The aerodynamic sizes of silica dust and lead fume have been determined by NIOSH. The silica dust has a mass median aerodynamic diameter (MMAD) of 2 km, and the lead fume has a MMAD of 1 Frn. The di-2-ethylhexyl phthalate (DEHP or DOP) test is performed on the HEPA filter. The filter is challenged with a heat generated monodisperse oil mist of DEHP having a size of 0.3 micrometer at a concentration of 100 milligrams per cubic meter. The air flow is 32 and 85 liters per minute for a single filter, or 16 and 42.5 liters per minute when the filters are used in pairs. The maximum allowable penetration is 0.03% after a test period of 5 to 10 seconds. The HEPA filter cartridge is the only respirator component listed in 30 CFR Part 11 for which the DOP test is performed on each cartridge manufactured. The DOP test is designed for certifying filters for protection against radioactive nuclei. In order to provide the maximum protection to the respirator wearer, the most penetrating particle size is used to challenge the filter. Particles having a size of 0.3 Frn, with a monodisperse distribution, are the most difficult size for filters to remove. A thermally generated monodisperse oil mist would meet the size criterion for the most penetrating aerosol. A very tight initial penetration requirement of 0.03% has been set for certifying filters for protection against radionuclides. Filters that meet this penetration requirement are called “high-efficiency” filters.
of Labor
This memorandum provides clarification for OSHA-wide enforcement policy and procedures for inspections concerning occupational exposure to tuberculosis (TB) for the private sector as well as Federal agencies. The policy set forth in this memorandum is effective immediately, with the exception of the requirements for the appropriate minimum level of respiratory protection which will be enforced ninety (90) days from this memorandum’s date of issuance. In response to employee complaints about occupational exposure to TB, OSHA has conducted inspections and issued citations where appropriate. The Directorate of Compliance Programs, with the assistance of the Directorate of Technical Support and OSHA Region II, is drafting a compliance directive providing enforcement guidance on occupational exposure to TB. This compliance directive will be based on the Centers for Disease Control and Prevention (CDC) final revision of their 1990 guidelines for preventing the transmission of tuberculosis in health care settings which is expected to be published in the coming year. The following agency-wide enforcement guidance is provided pending the issuance of the compliance directive and is based on the CDC’s current recommendations. Regional Administrators shall provide a copy of this memorandum to State plan designees and the designees shall advise the Regional Administrator of their intent regarding the State’s enforcement policy within thirty days of receipt of this memorandum. In the interest of providing consistently effective employee protection nationwide, State
This document is an OSHA memorandum for Regional Administrators from the Directorate of Compliance Programs, issued Oct. 8,1993. Attachment A, “Guidelines for Preventing the Transmission of Tuberculosis in Health-Care Settings, with Special Focus on HIV-Related Issues,” is not reprinted here but is available in the Centers for Disease Control and Prevention MorbicCyandMortaMy Week/yReport (MMWR 1990;38[RR-17]:1-28).
plan states are expected to implement enforcement policies and procedures for inspections concerning occupational exposure to TB as set forth in this memorandum, or to develop their own alternative enforcement program including extension of coverage to State and local government employees. Virtually all State plan states have in place a statutory requirement parallel to the general duty provision of section 5(a)(l) of the Occupational Safety and Health Act of 1970, which is a major aspect of federal OSHA’s TB enforcement policy. While section 18 of the Act does not require specifically that States adopt the S(a)(l) provision, the States are strongly encouraged to enforce their existing general duty requirements in a manner consistent with the Federal policy. In accordance with Executive Order 12 196, Section l-201, and 29 CFR 1960.16, Federal agencies must also follow the enforcement policy and procedures on TB contained in this document. BADKGROUND
Since 1985, the rate of new cases of TB in the general U.S. population has increased 18 percent, reversing a 30-year downward trend. In 1990, 25,500 new cases of TB were reported in the U.S. In New York City alone 3700 cases of TB were reported in 199 1. Recently, drug resistant strains of Mycobacterium tuberculosis have become a serious concern and cases of multi-drug resistant (MDR-TB) have occurred in forty states. In a recent New York City study, 33% of cases had organisms resistant to at least one drug, and 19% had organisms resistant to the two most effective drugs available for treating the disease. When organisms are resistant to both drugs the course of treatment increases from six months to 18-24 months, and the cure rate decreases from 100% to 60% or less. Since 1988, outbreaks of TB, including a multidrug resistant strain, have occurred at hospitals in 31A
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Atlanta, Miami, New York City, and New Jersey. In outbreaks at seven hospitals and one prison that the CDC have investigated, 16 health care workers have developed active multi-drug resistant TB (MDR-TB). At least five health care workers have died. Nationwide, at least several hundred employees have become infected after workplace exposure to TB and have required medical treatment. Approximately ten percent of normally healthy people who are infected will develop active TB disease within their lifetime. M. tuberculosis is carried through the air in infectious droplet nuclei of 1 to 5 microns in size. These droplet nuclei may be generated when a person with infectious TB disease coughs, speaks, sings, or spits. In an occupational setting, workers in close contact with persons with infectious tuberculosis disease are at increased risk of infection with TB. Certain high hazard medical procedures which are cough-inducing may further increase the risk of infection of health care workers. The employer’s responsibilities are set forth in the Occupational Safety and Health Act of 1970. However, in December 1990 the CDC published the “Guidelines for Preventing the Transmission of Tuberculosis in Health-Care Settings, with Special Focus on HIV-Related Issues” in its Morbidity and Mortality Weekly report (MMWRAttachment A). This document outlined general principles of TB control and the CDC’s specific recommendations including the hierarchy of controls to be implemented (e.g., early identification, isolation, medical surveillance, personal protective equipment). OSHA is relying on these guidelines as reflecting a widely recognized and accepted standard of protection to be followed by employers in carrying out their responsibilities under the OSH Act. The compliance procedures contained in this memorandum are also consistent with the agency’s traditional hierarchy of controls and good industrial hygiene practice which dictate that engineering controls be used wherever possible to eliminate or reduce the hazard at its source. When it is not possible to prevent employee exposure to the hazard, other measures such as administrative or work practice controls must be employed. Lastly, personal protective equipment shall be used to protect the employee. In May 1992, Region II, in conjunction with the New York State Public Employee Safety and Health Program and OSHA’s National Office, developed and issued “Enforcement Guidelines
for Occupational Exposure to Tuberculosis” in response to the increasing number of complaints received in area offices from health care workers occupationally exposed to TB. The purpose of the document was to provide compliance officers with guidance about how to protect themselves during TB-related inspections, and to outline the region’s enforcement requirements for such facilities. The Region II guidelines were based on the CDC 1990 “Guidelines for Preventing the Transmission of Tuberculosis in Health Care Settings with Special Focus on HIV-Related Issues” (Attachment A). Approximately 30 inspections of workplaces have been conducted nationwide. These inspections reveal that employers have not fully implemented the current CDC guidelines. INSPECTION
GUIDANCE
Inspections for occupational exposure to TB shall be conducted only in response to employee complaints or as part of all industrial hygiene compliance inspections conducted in workplaces where CDC has identified workers as having a greater incidence of TB infection. These workplaces have been the subject of reports issued by CDC which provide recommendations for the control of TB. Specifically, these workplaces are as follows: 1. health care settings’ 2. correctional institutions 3. homeless shelters 4. long-term care facilities for the elderly 5. drug treatment centers Complaints received from state and local government employees who are outside federal jurisdiction in Federal enforcement states shall be forwarded to the Regional Office for referral to the appropriate state agency. RECORDlNG
IN THE MIS
A TB-related inspection is any health inspection conducted for the purpose of investigating the presence or alleged presence of TB disease (i.e., a referral or complaint inspection) or any health inspection which results in a TB-related citation. When a TB inspection is conducted, as defined above, the OSHA-1 shall be completed as for any inspection. The code “N 02 TB” shall be entered in Item 42, Optional Information. All IMIS case file data for TB-related inspections conducted since October 1, 1990, shall be modified to include the appropriate TB code. 1. See MMWR, Attachment A, pg. 2.
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OFFICER PROTECTION
When responding to TB-related complaints, compliance officers are to take the following additional precautions: 1. Compliance officers shall not enter occupied isolation rooms to evaluate compliance. 2. Compliance
officers shall not enter work areas while high hazard procedures, such as aerosolized administration of medication, bronchoscopy, and diagnostic sputum induction, are being conducted.
3. When entry into potentially
hazardous areas is judged necessary, compliance officers shall be properly equipped as required by the facility as well as by their own professional judgment, after consultation with the supervisor. At a minimum, this shall include the use of a NIOSH-approved respirator equipped with high efficiency particulate air (HEPA) filters.
CITAWON DUIDANCE Eectton S(a)(l) - Deneral
Duty Clause
2. A suspected
exposure to the exhaled air of an with suspected2 or confirmed TB case
is one
in which
the facility
has
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2. Exposure to a high hazard procedure performed on an individual with suspected or confirmed TB disease and which has the potential to generate potentially infectious airborne respiratory secretions. Examples of high hazard procedures include aerosolized medication treatment, bronchoscopy, sputum induction, endotracheal intubation and suctioning procedures, and autopsies. Note that the hazard, not the absence of a particular means of abatement, is the basis for the general duty clause citation. All applicable abatement methods identified as correcting the same hazard shall be issued under a single 5(a)(l) citation. The following are examples of feasible and useful abatement methods. Failure to use any of these methods may result in the continued existence of a serious hazard and may, therefore, allow citation under 5(a)(l): 1. Protocol for the early identification uals with active tuberculosis.
of individ-
2. Medical
Occupational exposure to TB is a serious and recognized hazard and certain feasible abatement methods exist. Therefore, application of section 5(a)(l) of the OSH Act is warranted. Section 5(a)(l) citations must meet the requirements outlined in the FOM, Chapter IV, and may be issued where there is a hazard which cannot be abated by compliance with a specific OSHA standard. Industry recognition for purposes of citing section 5(a)(l) is recognition of the hazard of being infected with tuberculosis through the exposures detailed below. The workplaces under discussion (see Inspection Guidance) generally recognize the determination of this hazard by the CDC which is the acknowledged authority in this area. The employer’s TB program or generic infection control program can also constitute evidence of knowledge and recognition. Citations shall be issued only to employers whose employees work in one of the five types of facilities whose workers have been identified by the CDC as having a higher incidence of TB than the general population (see Inspection Guidance) and whose employees have exposure defined as follows: 1. Potential individual disease.
information
identified
an
surveillance (at no cost to employees) including preplacement evaluation, administration and interpretation of TB Mantoux skin tests, and periodic evaluations shall be offered to employees as follows: an initial baseline screening at the time of employment for all employees in the covered facilities; annually for all employees in the covered facilities; retesting every six months for workers with exposure as defined above (see MMWR pp. 1% 19, Attachment A).
3. Evaluation
and management (at no cost to employees) of workers with a positive skin test, or with skin test conversion on repeat testing, or who are exhibiting symptoms of TB, including work restrictions for infectious employees. Workers who experience a TB exposure incident (exposure to a patient/client with infectious TB for whom infection control precautions have not been taken) shall also be managed according to CDC recommendations (see MMWR p. 19, Attachment A). 4. Placement of individuals with suspected or confirmed TB disease in an AFB (acid fast bacilli) isolation room. AFB isolation rooms for persons with suspected or confirmed infectious TB and areas in which high hazard procedures individual as having symptoms consistent with TB. The CDC has identified the symptoms to be: productive cough, coughing up blood, weight loss, loss of appetite, lethargy/weakness, night sweats, or fever.
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are performed on such individuals must be maintained under negative pressure and appropriately exhausted (either directly to the outside away from intake vents or through properly designed, installed, and maintained HEPA filters). [Note that at the present time, the effectiveness of certain other engineering controls (such as local exhaust and UV lights) is being evaluated. However, given the serious nature of the TB hazard and the fact that such engineering controls may reduce the hazard to some degree, the compliance officer shall strongly encourage the employer to follow the CDC guidelines in the areas of local exhaust and UV lights.] 5. Training and information to ensure employee knowledge of such issues as the hazard of TB transmission, its signs and symptoms, medical surveillance and therapy, and site-specific protocols including the purpose and proper use of controls. (Note that failure to provide respiratory protection training is citable under 1910.134). If a citation is justified under 5(a)(l), the citation shall, after setting forth the SAVE for section 5(a)(l), state: “Workers [specify job classifications such as doctors, nurses, prison guards, etc.] [specify location] were exposed to the hazard of being infected with tuberculosis through contact with [specify group such as patients, inmates, clients, etc.] who were or may be infected with tuberculosis in that: [list exposure as detailed above]. Feasible and useful abatement methods for reducing this hazard, as recommended by the Centers for Disease Control, among others are: [list abatement methods as detailed above]. ” 29 CFR 1910.134-Respiratory
Protection:
The CDC’s 1990 Guidelines recommend that employees wear particulate respirators in the following circumstances: 1. When employees enter rooms housing individuals with suspected or confirmed infectious TB disease. 2. When employees perform high hazard procedures on individuals who have suspected or confirmed TB disease. Examples of high hazard procedures include aerosolized medication (e.g., pentamidine) treatment, bronchoscopy,
sputum induction, endotracheal intubation suctioning procedures, and autopsies.
and
3. When emergency-medical-response personnel or others must transport, in a closed vehicle, an individual with suspected or confirmed TB disease. In the above circumstances, employers must provide and ensure the use of NIOSH-approved high efficiency particulate air (HEPA) particulate respirators as the minimum acceptable level of respiratory protection. See Attachment B on Respirator Selection Logic for details. If a facility chooses to use disposable respirators as part of their respiratory protection program, their reuse is permitted as long as the respirator maintains its structural and functional integrity. The facility shall address the circumstances in which a disposable respirator will be considered to be contaminated and not available for reuse. Compliance officers shall cite 29 CFR 19 10.134 (a)(2), which requires that respirators be provided when necessary to protect employee health and that the respirators be suitable for the purpose intended, when less protective or no respiratory protection is provided. Whenever respirators (including disposables) are required to be used, a complete respiratory protection program must be in place in accordance with 29 CFR 1910.134(b). If a citation is warranted under 19 10.134, the following SAVE language may be used: “The employer did not provide respirators which were applicable and suitable for the purpose intended, nor was a respiratory protection program established which included the requirements outlined in 29 CFR 1910.134(b).” The following AVD shall be used when 1910.134(a)(2) is cited: (a) Employees were given a [LIST MANUFACTURER/MODEL NUMBER] mask for protection against airborne Mycobacferitlm ruberculosis. They should be using at least NIOSH-approved HEPA particulate respirators. NIOSH-approved respirators providing greater protection would also be acceptable.” 29 CFR 1910.143-Accident and Tags:
Prevention
Signs
In accordance in 1910.145(f)(8), a warning shall be posted outside the AFB isolation room.
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1910.145(f)(4) requires that a signal word be presented as well as a major message (e.g., “special respiratory isolation”, “AFB isolation”) or a description of the necessary precautions. 29 CFR 1910.29-Access Exposure and MedIcal
to Employee Records:
A record concerning employee exposure to TB is an employee exposure record within the meaning of 29 CFR 19 10.20. A record of TB skin testing results and medical evaluations and treatment is an employee medical record within the meaning 19 10.20. These records shall be handled according to 29 CFR 1913.10 so that the compliance officer may determine compliance with 29 CFR 1910.20. 29 CFR 1994-Lqj and Summary of Occupational Infuries and Illnessas:
TB infections (positive TB Mantoux skin test) and TB disease are both recordable on the OSHA 200 log in the above-referenced high risk settings. A positive skin test for TB, even on baseline testing (except pre-employment screening), is recordable on the OSHA 200 log because there is a presumption of work-relatedness in these settings. Federal agency recordkeeping requirements are outlined in Part 1960 Program Elements, Subpart I, and in “Recordkeeping and Reporting Guidelines for Federal Agencies” (OSHA publication 2014). If an employee’s TB infection which has been entered on the OSHA 200 log progresses to TB disease during the five year maintenance period, the original entry for the infection shall be updated to reflect the new information. Because it is clinically difficult to determine if TB disease resulted from the source indicated by the skin test conversion or from subsequent exposures, only one case should be entered to avoid double counting. CITATION
REVIEW
Until further notice, all citations proposed under these guidelines shall be reviewed prior to issuance at the Regional Office level. Where necessary for proposed 5(a)( 1) and 1910.134 citations, the regional office shall contact the Directorate of Technical Support for coordination of expert testimony. AGENCY OUTREACH AND ASSISTANCE
The agency recognizes the need for a national outreach effort and is currently planning the
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coordination of such an effort. In addition, the Regional and Area Offices are strongly encouraged, to the extent permissible by resources, to work with local institutions and associations representing affected facilities in an educational and outreach effort. ATTACHMENT 6: RESPIRA’TOR SELECTtON LODlC*
OSHA has identified the appropriate minimum level of respiratory protection for occupational exposure to TB, based on the following best available information regarding the characteristics of exposure and the feasibility of compliance: l
l
The minimum respiratory protection is a NIOSH-approved high-efficiency particulate air (HEPA) particulate respirator. The employer must establish and implement a respiratory protection program in accordance with the requirements of OSHA’s respiratory protection standard, 29 CFR 1910.134.
In making the selection of respirators for protection against TB, it was necessary to consider factors which affect the performance of respirators such as filter performance, face seal leakage and fit check. These factors are as follows: FACTOR # 1: Identification and selection rationale of the appropriate minimum level of respiratory protection for occupational exposure to TB.
Engineering controls must be implemented to reduce the risk of exposure to TB. The selection of respirators to supplement engineering controls, is usually based on the permissible exposure limit for the air contaminant in question. There is no known safe exposure level for TB. Therefore, it is prudent to select respirators which would provide minimal margin of error since each additional inhaled TB bacillus may increase the risk of disease. The nature of work in connection with TB patients is a critical factor that must be kept in mind in selecting appropriate respirators for exposure to TB. Respiratory protection requirements will be modified later if a threshold for TB exposure is established. Since there is no established safe exposure level for TB, NIOSH recommends that hospitals use powered air-purifying respirators (PAPRs) as the *Attachment A, “Guidelines for Preventing the Transmission of Tuberculosis in Health-Care Settings, with Special Focus on HIV-Related Issues,” is not reprinted here but is available in the Centers for Disease Control and Prevention MorbidityandMorfality Week/y Report (MMWR 1990;38[RR-17]:1-28).
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minimum level of respiratory protection for exposure to TB. OSHA, however, recognizes that PAPRs may interfere with patient care, or could be infeasible for other reasons. Therefore, OSHA does not require the use of PAPRs as the minimum level of acceptable respiratory protection. Based on the best currently available information on respirator filters and respirator characteristics, OSHA requires the use of a NIOSH-approved HEPA particulate respirator for workers in TB patient isolation rooms, during high hazard procedures, and involved in medical transport in closed vehicles as the minimum level of protection. In order to minimize the exposure to TB, effective fit tests and fit checks must be performed. Quantitative or qualitative fit testing must be performed for each respirator wearer. The quantitative fit testing (QNFT) is the most reliable fit testing method. (OSHA has accepted several qualitative fit testing [QLFTJ agents such as isoamyl acetate, irritant fume and sodium saccharin. The mass median aerodynamic diameter for the saccharin aerosol is 3 wrn and the irritant fume is in the submicrometer size range. The irritant fume QLFT is considered to be the more reliable test agent since the saccharin QLFT is dependent on the subjective response of the test subject to the taste of the saccharin mist while the irritant fume QLFT elicits the test subject’s involuntary response to the fume.) Appendix C of the asbestos standard, 29 CFR 1910.1001, should be used as a guide for performing fit testing. It should be noted that some molded fabric type respirators are valveless or have an exhalation valve which cannot be blocked by the hand. An effective fit check may be difficult to perform on these respirators. In these cases, fit checks should be done according to manufacturers’ instructions. FACTOR #2: The filtration characteristics and filtration efficiencies of the different types of particulate respirators, e.g. Dust/Mist, Dust/Fume/Mist, and HEPA. Comparison and clarification about the significance of the size of the challenge particulate, the mean aerodynamic diameter of the challenge particulate, and whether the filtration efficiency is dependent on filter loading.
The OSHA standards on respiratory protection, 29 CFR 1910.134, and air contaminants, 29 CFR 1910. lOXX, require the use of respirators which are jointly approved by the Mine Safety and Health Administration (MSHA) and the National Institute for Occupational Safety and Health (NIOSH) under the provisions of 30 CFR Part 11. The test
December
1993
methods for air-purifying respirators equipped with particulate filters are prescribed in 30 CFR Part 11. Schedule K, which includes performance tests for single use, dust/mist, fume and HEPA filters. A discussion of different filter testing methods appears under Factor # 3. NIOSH’s dust filter certification test requires a challenge of a very high concentration (50 milligrams per cubic meter) of silica dust, and an integrated penetration is the only required measurement at the end of a 90 minute test. The integrated measurement method permits the use of less efficient filter media which allow the penetration of fine particles until a cake is built upon the respirator filter surface (filter “loading”). This in turn decreases the penetration of particles, and meets the integrated penetration requirement. This type of measurement also applies to the dust/mist/fume filter. CDC3 states that the size of the droplet nuclei carrying the TB bacilli is between l-5 pm. There is no assurance that the MSHA/NIOSH approved dust/mist or dust/mist/fume filters classified in accordance with the current certification methods would remove airborne droplet nuclei containing the TB bacteria. Furthermore, the certification tests for dust/mist and dust/mist/fume filters do not evaluate initial filter efficiency. Respirators with HEPA filters are the only currently available certified respirators that meet or exceed the required filter efficacy against low-concentration aerosols in the size range of droplet nuclei. MSHA/NIOSH-approved HEPA filters are effective against all sizes of particles (including the 1 to 5 pm range) upon first donning (without dependence on filter loading). In addition, every HEPA filter must be verified by the manufacturer for meeting the di-2-ethylhexyl phthalate (DOP) penetration requirement described below. FACTOR #3: The NIOSH evaluation methods for the different types of particulate respirators.
The NIOSH evaluation method is detailed in schedule K of 30 CFR Part 11. An overview of Schedule K is as follows: Different test schedules are listed in 30 CFR Part 11 for approval of different classes of respirators. The test method for air-purifying respirators 3. NIOSH Recommended Guidelines for Personal Respiratory Protection of Workers in Health-Care Facilities Potentially Exposed to Tuberculosis. Atlanta, Georgia: U.S. Department of Health and Human Services, Public Health Service, 1992.
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equipped with particulate filters are prescribed in Schedule K of this part. It includes performance tests for single use, dust/mist, dust/mist/fume, and HEPA filters. Usually, a respirator which receives the high-efficiency approval also includes the fume, dust and mist approvals. The fume approval also includes the approval for dust and mist. The dust approval also includes the approval for mist. Three types of aerosols, silica, lead fume, and di-2-ethylhexyl phthalate, have been used for certifying particulate respirators. Polydisperse silica dust having a projected particle diameter of 0.4 to 0.6 micrometers (measured by a microscope) is used for testing dust and single use filters. The test is performed inside a dust chamber at a concentration between 50 to 60 milligrams per cubic meter. The temperature is approximately 25” C and the relative humidity may vary from 20% to 80%. The test period is 90 minutes at a flow rate of 32 liters per minute for non-powered respirators. The flow rate for tight and loose fitting inlet covering powered air-purifying respirators (PAPR) is 115 liters (4 cubic feet) per minute and 170 liters (6 cubic feet) per minute respectively, and the test period for the PAPR’s is 4 hours. Since single use respirators are valveless, the filter performance test is performed on a breathing machine at a rate of 24 respirations per minute with a minute volume of 40 liters per minute. When the filters are placed in pairs or in triplets, the air flow to each filter element will be reduced accordingly. For example, if two filter elements are used on a twin cartridge respirator, the air flow to each filter will be half of 32 lpm or 16 lpm. The maximum allowable filter penetration is 1% for all filters listed in Subpart K, except for the HEPA filter which is 0.03%. The performance test requirements for the polydisperse silica mist is similar to the test for silica dust, except that an aqueous suspension of silica at a concentration between 20 and 25 milligrams per cubic meter replaces the silica
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dust, and also the test time for the non-powered respirator is 3 12 minutes. The polydisperse lead fume test is performed in a test chamber with freshly generated lead oxide fumes at a concentration from 15 to 20 milligrams of Pb per cubic meter of air. Other test conditions, including air flow, are the same as the silica dust test except that the test period is 3 12 minutes for non powered, and 4 hours for powered respirators. The maximum allowable filter penetration is 1%. The aerodynamic sizes of silica dust and lead fume have been determined by NIOSH. The silica dust has a mass median aerodynamic diameter (MMAD) of 2 km, and the lead fume has a MMAD of 1 Frn. The di-2-ethylhexyl phthalate (DEHP or DOP) test is performed on the HEPA filter. The filter is challenged with a heat generated monodisperse oil mist of DEHP having a size of 0.3 micrometer at a concentration of 100 milligrams per cubic meter. The air flow is 32 and 85 liters per minute for a single filter, or 16 and 42.5 liters per minute when the filters are used in pairs. The maximum allowable penetration is 0.03% after a test period of 5 to 10 seconds. The HEPA filter cartridge is the only respirator component listed in 30 CFR Part 11 for which the DOP test is performed on each cartridge manufactured. The DOP test is designed for certifying filters for protection against radioactive nuclei. In order to provide the maximum protection to the respirator wearer, the most penetrating particle size is used to challenge the filter. Particles having a size of 0.3 Frn, with a monodisperse distribution, are the most difficult size for filters to remove. A thermally generated monodisperse oil mist would meet the size criterion for the most penetrating aerosol. A very tight initial penetration requirement of 0.03% has been set for certifying filters for protection against radionuclides. Filters that meet this penetration requirement are called “high-efficiency” filters.