These guidelines supercede state OSHA regs when there are none for toxic exposures, such as mold. State Occupational Health and Safety Plans exist in 22 states. "State Plan States are required to have standards, policies and procedures at least as effective as those of Federal OSHA and to respond to significant new changes to the Federal program." http://osha.gov/dcsp/osp/std_fpc.html
OSHA began making Indoor Air Quality standards in the 1990's, but these were terminated in 2001. The proposed standards are found below, and do support the serious harm that molds and mycotoxins cause to the health of occupants in mold-contaminated buildings, including causing death. "Building-related illnesses can result in serious illness and death."(from 2. Microbial Contamination, below) (SMH)
Do not be fooled into believing that there is a safe level for mold. There isn't. Federal OSHA states this, below (SMH).
U. S. Department of Labor
Occupational Safety and Health Administration
Directorate of Science, Technology and Medicine
Office of Science and Technology Assessment
A Brief Guide to Molds in the Workplace - Information Bulletin SHIB 03-10-10
Safety and Health Information Bulletin
..."In addition, there are no standards for “acceptable” levels of mold in buildings, and the lack of a definitive correlation between exposure levels and health effects makes interpreting the data difficult, if not impossible."*
A Brief Guide to Molds in the Workplace - Information Bulletin SHIB 03-10-10
Fact Sheet on Natural Disaster Recovery: Fungi
Fungi - OSHA Fact Sheet (2003)
Molds and Fungi - Safety and Health Topics
Respiratory Protection. Final Rules 63:1152-1300, (1998, January 8). Justifies the use of respirators to prevent the inhalation of harmful airborne contaminants that are alive or were released from a living organism. Respirators protect against bacterial infections resulting from inhalation of bacteria and their products that cause a range of diseases. ""Bioaerosols" are airborne contaminants that are alive or were released from a living organism (OSHA Docket No. H-122; ACGIH Guidelines; Ex. 3-61C, page 1; 1994). Pulmonary effects associated with exposure to certain bioaerosols include rhinitis, asthma, allergies, hypersensitivity diseases, humidifier fever, and epidemics of infections including colds, viruses, tuberculosis, and Legionnaires Disease. Cardiovascular effects manifested as chest pain, and nervous system effects manifested as headache, blurred vision, and impaired judgment, have occurred in susceptible people following exposure to bioaerosols. Viral infections caused by the inhalation of bioaerosols can result in health effects that range in intensity from undetected or mild to more severe and even death. Bacterial infections resulting from inhalation of bacteria and their products cause a range of diseases, including tuberculosis, Legionnaires Disease, and hypersensitivity pneumonitis. Among workers in sewage treatment plants, health-related problems can be associated with occupational exposures to protozoa [Burge, H., 1990, "Bioaerosols: Prevalence and health effects in the indoor environment," J. Allergy and Clinical Immunology; 86 (5); see also Exs. 3-61B and 3-61C in Docket No. H-122.] Allergic asthma and allergic rhinitis can be induced by chronic exposure to low levels of antigens. Hypersensitivity pneumonitis can occur when a worker inhales concentrated aerosols of particles released by bacteria, fungi, and protozoa (Exs. 3-61B and 3-61C in Docket No. H-122). In 1994, the Centers for Disease Control reported 41 deaths of workers for which there was evidence of work-related hypersensitivity pneumonitis (Work-Related Lung Disease Surveillance Report, 1994; USDHHS, CDC, DHHS (NIOSH) Number 94-120). Respirators to protect against the inhalation of biological agents are widely used in healthcare and other workplace settings where exposure to such agents presents a hazard to workers."
*for more info on Dose Response and Mold Exposure click here
Indoor Air Quality. Proposed Rules 59:15968-16039, (1994, April 5). OSHA proposed to adopt standards that addressed indoor air quality in indoor work environments
Indoor Air Quality - 59:15968-16039
|Federal Registers - Table of Contents
|• Publication Date:||04/05/1994|
|• Publication Type:||Proposed Rules|
|• Fed Register #:||59:15968-16039|
|• Title:||Indoor Air Quality|
Notice: On December 17, 2001 OSHA withdrew its Indoor Air Quality proposal and terminated the rulemaking proceedings, see Federal Register 66:64946.
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Parts 1910, 1915, 1926, 1928
[Docket No. H-122]
Indoor Air Quality
AGENCY: Occupational Safety and Health Administration (OSHA), Labor.
ACTION: Notice of proposed rulemaking; notice of informal public hearing.
SUMMARY: By this notice, the Occupational Safety and Health Administration (OSHA) proposes to adopt standards addressing indoor air quality in indoor work environments. The basis for this proposed action is a preliminary determination that employees working in indoor work environments face a significant risk of material impairment to their health due to poor indoor air quality, and that compliance with the provisions proposed in this notice will substantially reduce that risk.
The provisions of the standard are proposed to apply to all indoor "nonindustrial work environments." In addition, all worksites, both industrial and nonindustrial within OSHA's jurisdiction are covered with respect to the proposed provisions addressing control of environmental tobacco smoke. The proposal would require affected employers to develop a written indoor air quality compliance plan and implement that plan through actions such as inspection and maintenance of building systems which influence indoor air quality.
Provisions under the standard also propose to require employers to implement controls for specific contaminants and their sources such as outdoor air contaminants, microbial contamination, maintenance and cleaning chemicals, pesticides, and other hazardous chemicals within indoor work environments. Designated smoking areas which are to be separate, enclosed rooms exhausted directly to the outside are proposed to be required in buildings where the smoking of tobacco products is not prohibited. Specific provisions are also proposed to limit the degradation of indoor air quality during the performance of renovation, remodeling and similar activities. Provisions for information and training of building system maintenance and operation workers and other employees within the facility are also included in this notice.
Finally, proposed provisions in this notice address the establishment, retention, availability, and transfer of records such as inspection and maintenance records, records of written compliance programs, and employee complaints of building-related illness.
The Agency invites the submission of written data, views and comments on all regulatory provisions proposed in this notice, and on all relevant issues pertinent to those provisions. OSHA is also scheduling an informal public hearing where persons may orally submit their views. It is noted here that subsequent Federal Register notices may be published subsequent to this notice, if the public presents views leading to a substantial change in focus or it is otherwise determined to be appropriate.
DATES: Comments on the proposed standard must be postmarked by June 29, 1994. Notices of intention to appear must be postmarked by June 20, 1994. Testimony and evidence to be submitted at the hearing must be postmarked by July 5, 1994. The hearing will commence at 9:30 a.m. on July 12, 1994.
ADDRESSES: Comments are to be submitted in quadruplicate or 1 original (hardcopy) and 1 disk (5 1/4 or 3 1/2) in WP 5.0, 5.1, 6.0 or Ascii to: The Docket Office, Docket No. H-122, Room N-2625, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210, Telephone No. (202) 219-7894. (Any information not contained on disk, e.g., studies, articles, etc., must be submitted in quadruplicate.) Notices of intention to appear and testimony and evidence are to be submitted in quadruplicate to: Mr. Tom Hall, Division of Consumer Affairs, Occupational Safety and Health Administration, 200 Constitution Avenue, NW., room N3649, Washington, DC 20210; (202) 219-8615.
The hearing will be held in the auditorium of the U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC.
FOR FURTHER INFORMATION CONTACT: Proposal: Mr. James F. Foster, Director of Information and Consumer Affairs, Occupational Safety and Health Administration, 200 Constitution Avenue, NW., room N3641, Washington, DC 20210; (202) 219-8151.
Informal Hearing Information: Mr. Tom Hall, Division of Consumer Affairs, Occupational Safety and Health Administration, 200 Constitution Avenue, NW., room N3649, Washington, DC 20210; (202) 219-8615.
Table of Contents
I. Supplementary Information
A. Events Leading to This Action
II. Health Effects
A. Sick Building Syndrome
B. Building-Related Illness
1. Indoor Air Contaminants
2. Microbial Contaminants
C. Environmental Tobacco Smoke
(a) Absorption and Distribution
3. Pulmonary Effects
4. Cardiovascular Effects
(a) Thrombus Formation
(b) Vascular Wall Injury
(c) Possible Mechanisms of Effect
(d) Acute Heart Effects
(e) Chronic Heart Effects
5. Reproductive Effects
(a) Evidence of Association
(b) Epidemiological and Experimental Studies
D. Case Reports
1. Sick Building Syndrome and Building-Related Illness
2. Environmental Tobacco Smoke
A. Sources of Indoor Air Contaminants
B. Microbial Contamination
C. Exposure Studies
1. Low-level Contaminants
3. Environmental Tobacco Smoke
(b) Human Activity Pattern Studies Used to Assess
(c) Indoor Levels of Environmental Tobacco Smoke
(d) Levels of Respirable Suspended Particulates
and Nicotine Found in Field Studies
(e) Biomarkers of Environmental Tobacco Smoke
(f) Inadequacy of General Dilution Ventilation to
Address Environmental Tobacco Smoke Exposure
IV. Preliminary Quantitative Risk Assessment
B. Review of Epidemiologic Studies and Published Risk
C. Data Sources
D. OSHA's Estimates of Risk-Environmental Tobacco Smoke
E. OSHA's Risk Estimates - Indoor Air Quality
F. Pharmacokinetic Modeling of Environmental Tobacco Smoke
1. Considerations for Selection of a Biomarker for
Environmental Tobacco Smoke
2. Cardiovascular Effects
4. Evaluation of Cotinine as a Biomarker for
Environmental Tobacco Smoke
5. Description of Pharmacokinetic Models for Nicotine
6. Application of Pharmacokinetic Modeling for
Environmental Tobacco Smoke Exposure Estimation
7. Analysis of Uncertainty
(a) Physiological Parameters
(b) Distribution Parameters
(c) Kinetic Parameters
V. Significance of Risk
A. Environmental Tobacco Smoke
B. Indoor Air Quality
VI. Preliminary Regulatory Impact Analysis
B. Industry Profile
1. Affected Industries
2. Indoor Contaminants-Sources
3. Controlling Indoor Air
4. Building Characteristics
5. Profile of Affected Buildings
6. Buildings with Indoor Air Problems
7. Number of Employees Affected
8. Environmental Tobacco Smoke
(a) Smoking Ordinances and Policies
(b) Number of Nonsmokers Working Indoors
C. Nonregulatory Alternatives
2. Market Imperfections
3. Alternative Nonregulatory Options
(a) Tort Liability
(b) Workers' Compensation
1. Indoor Air Quality
2. Environmental Tobacco Smoke
3. Cost Savings
(a) Worker Productivity
(b) Property Damage, Maintenance and Cleaning
E. Technological Feasibility and Compliance Costs
1. Technological Feasibility
2. Compliance Costs
(a) Developing Indoor Air Quality Compliance
(b) Indoor Air Quality Operation and Maintenance
(c) Training for HVAC Maintenance Workers and
Informing Employees About the Indoor Air
(d) Compliance with Related Standards
(e) Air Contaminant-Tobacco Smoke
(f) Air Quality During Renovation and Remodeling
F. Economic Impact and Regulatory Flexibility Analysis
1. Economic Feasibility
2. Regulatory Flexibility Analysis
3. Environmental Impact
VII. Summary and Explanation
A. Scope and Application: Paragraph (a)
B. Definitions: Paragraph (b)
C. Indoor Air Quality Compliance Program: Paragraph (c)
D. Compliance Program Implementation: Paragraph (d)
E. Controls for Specific Contaminant Sources: Paragraph (e)
F. Air Quality During Renovation and Remodeling: Paragraph (f)
G. Employee Information and Training: Paragraph (g)
H. Recordkeeping: Paragraph (h)
I. Dates: Paragraph (i)
J. Appendices: Paragraph (j)
K. Specific Issues
VIII. State-Plan Standards
X. Information Collection Requirements
XI. Public Participation
XII. List of Subjects in 29 CFR Parts 1910, 1915, 1926, and 1928
XIII. Authority and Signature
XIV. Part 1910, 1915, 1926, 1928 - Proposed Occupational Safety
and Health Standards
A. Events Leading to This Action
Concern about the health hazards posed by occupational exposure to environmental tobacco smoke (ETS) prompted three public interest groups to petition the Agency in May 1987 for an Emergency Temporary Standard under section 6(c) of the Occupational Safety and Health (OSH) Act, 29 U.S.C. 655(c). The American Public Health Association and Public Citizen submitted a joint petition; Action on Smoking and Health (ASH) also submitted a petition. The petitions requested the prohibition of smoking in most indoor workplaces.
OSHA determined, that available data with respect to exposures were insufficient to demonstrate the existence of a "grave danger," within the meaning of section 6(c) of the OSH Act, from workplace exposure to ETS. OSHA denied the petitions in September 1989 but continued to investigate regulatory options.
In October 1989 ASH filed suit in the U.S. Court of Appeals for the District of Columbia Circuit for review of OSHA's denial of its petition for an Emergency Temporary Standard. The court denied ASH's petition for review in May 1991, finding that OSHA has reasonably determined that it could not sufficiently quantify the workplace risk associated with tobacco smoke to justify an Emergency Temporary Standard.
OSHA issued on September 20, 1991, a Request for Information (RFI) (56 FR 47892) on indoor air quality problems, in order to obtain information necessary to determine whether it would be appropriate and feasible to pursue regulatory action concerning Indoor Air Quality (IAQ). Issues on which comments were requested in the RFI included health effects attributable to poor IAQ, ventilation systems performance, exposure assessment, and abatement methods. Information concerning specific contaminants such as ETS and bioaerosols was also requested.
In March 1992, the AFL-CIO petitioned OSHA to promulgate an overall IAQ standard. OSHA responded in May 1992 that such a standard was under consideration.
In response to the RFI, over 1,200 comments were submitted by interested persons, groups, unions, and industries. Issues of particular concern identified in the comments, in addition to health effects considerations, include the lack of ventilation performance standards; the lack of worker training on the operation and maintenance of Heating Ventilation and Air Conditioning (HVAC) systems; the lack of pollutant source control; and the lack of available technical guidance on IAQ issues and control techniques.
Of the comments that specifically addressed the question of whether OSHA should regulate IAQ, a majority (75%) indicate support for regulation. Of those that commented on the need for regulation, approximately 21% were explicitly in favor of a regulation on ETS, more than 41% were in favor of an overall IAQ regulation, and approximately 13% were in favor of a combined IAQ regulation.
Numerous comments focused on the adverse health effects of tobacco smoke and of general indoor air pollution. The health effects of concern relevant to both tobacco smoke and indoor air pollutants ranged from the acute irritant effects to cancer.
Comments submitted in response to the RFI indicated wide support for a regulatory approach that would focus on the design, operation and maintenance of building ventilation systems, source reduction methodology, and worker information and training programs. Commenters also recommended that provisions should require that employers receive training about the regulation and the need for compliance, and that their training regarding building HVAC maintenance and operation be tailored to the level of complexity of the HVAC system and their personal degree of involvement.
Many commenters particularly felt that regulation of IAQ was necessary to eliminate exposures to ETS in the workplace. Commenters urged the Agency to either ban smoking completely from the workplace or allow smoking only in separately ventilated, designated smoking areas that were separate from work areas.
OSHA believes that data submitted to the record, and other evidence, support the conclusion that air contaminants and other air quality factors can act to present a significant risk of material impairment to employees working in indoor environments. Adverse health effects associated with poor IAQ may include sensory irritation, respiratory allergies, asthma, nosocomial infections, humidifier fever, hypersensitivity pneumonitis, Legionnaires' disease, and the signs and symptoms characteristic of exposure to chemical or biologic substances such as carbon monoxide, formaldehyde, pesticides, endotoxins, or mycotoxins.
The Agency believes that available data support proposing regulation of IAQ, including exposure to ETS. Further stimulus for this determination was provided by conclusions reached in a report published in December, 1992 by the Environmental Protection Agency, addressing hazards associated with exposure to ETS. In that study, Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders [Ex. 4-311], EPA concluded that exposure to ETS presents an excess risk of induction of cancer in humans. OSHA has submitted this proposed standard to the U.S. Environmental Protection Agency which is reviewing it in detail for purposes of submitting detailed comments to the docket.
For the reasons noted above, and discussed in the following sections, OSHA is proposing to address indoor air quality problems, including exposure to ETS, as set forth in this notice.
II. Health Effects
Indoor air quality problems can occur in all types and ages of buildings; in newly constructed buildings, in renovated or remodeled buildings, and in old buildings. Problems in new, clean buildings are rarely, if ever, related to microbial growth, since the physical structures are new [Ex. 3-61]. Older buildings that have not been adequately maintained and operated may have problems with bioaerosols if parts of the building have been allowed to become reservoirs for microbial growth. Also, if inadequate outside air is provided, regardless of the age of the building, chemical and biological contaminants will build up to levels that can cause health effects in some workers. In addition, other physical factors such as lack of windows, noise, and inadequate lighting, and ergonomic factors involving uncomfortable furniture and intensive use of video display units, etc., will cause discomfort in occupants that may be inaccurately attributed to air quality.
Some information contained in the docket indicates that these chronic health complaints are psychological, however, OSHA believes that chronic health complaints related to poor indoor air quality are unlikely to be due to mass psychogenic illness, even though a psychological overlay is common. It is true that poor management, boring work, poor lighting conditions, temperature variations, poor ergonomic design, and noise may all lower the threshold for complaint. Nevertheless, air quality complaints usually have some basis, although they are often difficult to assess with specificity [Exs. 3-61C, 4-144].
Indoor air quality problems are generally classified as Sick Building Syndrome (SBS) or Building-related Illness (BRI). However, a very important constituent of poor indoor air quality is ETS because of the serious health effects that result from exposure. The following discussion will first identify the health effects associated with SBS and BRI. A discussion of the health effects associated with exposure to ETS will follow.
It is important to note that OSHA considers these health effects to be material impairments of health when the worker is clinically diagnosed with a condition that is either caused or aggravated by poor indoor air quality in the workplace. For example, in the formaldehyde standard (29 CFR 1910.1048) [Ex. 4-107] OSHA determined that a physician's diagnosis of irritation met the requirement of material impairment of health. In addition, OSHA considers all the other health effects discussed, which are more clinically severe than irritation, to be material impairments of health as well.
A. Sick Building Syndrome
Typically, health effects caused by poor indoor air quality have been categorized as SBS or BRI. In 1983, the World Health Organization published a list of eight non-inclusive symptoms that characterize Sick Building Syndrome [Ex. 4-325]. These include irritation of the eyes, nose and throat; dry mucous membranes and skin; erythema; mental fatigue and headache; respiratory infections and cough; hoarseness of voice and wheezing; hypersensitivity reactions; and nausea and dizziness. Generally, these conditions are not easily traced to a specific substance, but are perceived as resulting from some unidentified contaminant or combination of contaminants. Symptoms are relieved when the employee leaves the building and may be reduced or eliminated by modifying the ventilation system. Comments to the docket indicate that such symptoms have been observed in and reported by workers [Exs. 3-446, 4-87].
In some instances, outbreaks of SBS are identified with specific pollutant exposures, but in general only general etiologic factors related to building design, operation and maintenance can be identified [Ex. 4-274]. In 1987, Woods et al. [Ex. 3-745] conducted a stratified random telephone survey of 600 U.S. office workers across the national. Twenty four percent reported that they were dissatisfied with the air quality at the office; while 20% perceived their performance to be hampered by poor indoor air quality. Women were nearly twice as likely to report a productivity effect of poor indoor air quality than men (28% versus 15%). Based on this, Woods et al. [Ex. 3-745] hypothesized that 20% of U.S. office workers are exposed to indoor conditions which manifest as SBS. In fact, complaints about SBS have become so numerous that 37 out of 53 states and territories have designated a building complaints investigation contact person [Ex. 4-310].
Breysse [Ex. 4-32] reported on symptoms associated with new carpeting in a state office building, in order of prevalence: headache, eye and throat irritation, nausea, dizziness, eye tearing, chest tightness, diarrhea, cough, muscle aches, burning nose, fatigue, dark urine, and rashes. Twenty out of 35 persons were affected. Air sampling was conducted before and after carpet removal; a similar range of aliphatic hydrocarbons was found after removal, but in much lower concentrations. Many individuals who believe the building they work in is implicated in SBS, have described similar effects. Symptoms usually include one or more of the following: mucous membrane (eye, nose, or throat) irritation, dry skin, headache, nausea, fatigue, and lethargy [Ex. 4-293]. These symptoms are generally believed to result from indoor air pollution. There is no secondary spread of symptoms to others outside the building who are exposed to the occupants (unlike the situation faced by many chemical and asbestos workers). Anderson [Ex. 4-10] suggested the possible causes for SBS as related to psychosocial, chemical, physical, or biological factors.
Anderson [Ex. 4-10] distinguished SBS symptoms as different from mass psychogenic illness; although in general the causes of SBS are unknown, he suggested that most SBS symptoms could be explained by stimulation of sensory nerve fibers in the upper airways and the face (referred to as common chemical sense). Because these fibers can respond in only one way, SBS cases largely have the same symptoms irrespective of the cause [Ex. 4-10].
It is now known that there is a variety of important health effects from indoor air pollution. In addition to the indoor environmental disease caused by infectious agents, carcinogens or toxins; the indoor environment may create conditions that can produce skin and mucosal allergy and hyperactivity reactions, sensory effects (odors and irritations), airways effects (from both acute and chronic exposures), neuropsychological effects, and psychosocial effects, especially due to the lack of social support [Ex. 4-200].
Indoor air pollution may be caused by physical, chemical, or microbiological agents, and is aggravated by poor ventilation. The causation of SBS by indoor air pollution was first objectively demonstrated in 1984 in a study of 62 Danish subjects suffering from "indoor climate symptoms" [Ex. 4-20]. These subjects reported primarily eye and upper respiratory irritation, but were otherwise healthy individuals, and did not suffer from asthma, allergy, or bronchitis. The subjects were exposed to a mixture of 22 volatile organic chemicals commonly found in the indoor environment at concentrations of 0, 5, and 25 mg/m(3). These concentrations corresponded respectively to "clean" air, average polluted air in Danish houses, and maximum polluted air in Danish houses. After exposure, the Digit Span test was administered. The Digit Span test consists of the subject being allowed to view a series of random digits for a short period of time; the numbers are then covered up and the subject asked to repeat the sequence backwards. This test is reported to be sensitive to situational anxiety and alertness, and therefore a measure of stress and ability to concentrate. Bach et al. found significant declines in performance on the digit span test following exposure to these low levels of volatile organic chemicals, demonstrating objectively the existence of SBS [Ex. 4-20].
Molhave et al. [Ex. 4-228], in reporting on the same 62 subjects, found that subjects exposed for 2 3/4 hrs did not adapt, and that the subjects reacted to irritation of the mucous membranes and not to odor intensity. The exposure was doubled-blind, and neither the subjects nor the testers knew the exposure.
Although these problems have been demonstrated to be real, they may affect only a small percentage of building occupants. Also, there are various degrees of problems which may occur. Some individuals who experience relatively mild and treatable symptoms such as headache, may be able to cope with the sick building environment for extended periods, although suffering from increased stress. Other individuals, more seriously affected, may find symptoms so severe that they may be unable to be in the building for extended periods, or at all. Still others may become temporarily or permanently disabled.
It has been suggested that SBS may not be one syndrome but a number of sub-syndromes [Ex. 4-170]. This hypothesis suggests that the symptoms particularly associated with chemical exposure include fatigue; headache; dry and irritated eyes, nose, and throat; and sometimes include nausea and dizziness. Those symptoms most related to microbial exposures would result in itchy, congested, or runny nose; itchy watery eyes; and sometimes include wheezing, tight chest, or flu-like symptoms. The overlapping symptoms in each case are eye, nose, and throat irritation, perhaps making the two sub-syndromes, chemical and microbial, difficult to distinguish. Jones concludes that there is a need for a treatment protocol as well as a diagnostic protocol, which, in addition to describing corrective actions available in response to different diagnostic findings, would also provide guidelines for the design and implementation of follow-up studies of buildings and individuals in order to assess treatment effectiveness [Ex. 3-170].
Randolph and Moss [Ex. 4-258] have written about a number of problems ascribed to indoor air pollution in the chemically sensitive patient. These problems include irritability from natural gas fumes, allergy to dust from forced air ventilation systems, intoxication and even hallucination from paint fumes. Randolph describes chemical sensitivity to dry cleaning chemicals, and rug shampoo, and implicates moldy carpets in producing allergenic substances. He also describes joint pain, malaise, and fatigue due to pesticide exposure; and skin rashes from exposure to plasticizers. Randolph further describes intolerance to highly scented products such as deodorant soaps, toilet deodorants, and disinfectants, especially pine-scented ones. Other patients have reported reacting to strong perfumes and other cosmetics. So-called air fresheners often prove to be particularly troublesome. He also describes that some patients are sensitive to the odors from hot plastic-coated wires in electronic equipment.
There is little data on the perceptions of victims of SBS. Shapiro [Ex. 4-282] has complied a summary of 16 case-histories of SBS in the victims' own words. It is useful to review these for insight into the problems from the victims' point of view.
One episode that Shapiro [Ex. 4-282] reported on was in a building occupied by a government agency. As a result of problems related to carpeting and other suspected causes, five workers were reported to have left the agency, 11 were relocated to alternative workspace or worked at home, and 100 reported to the agency's medical officer that they had SBS related problems. The range of self-reported symptoms included a variety of moderate and acute respiratory problems; headache; sore throat; burning of the eyes, lungs, and skin; rashes; fatigue; laryngitis; clumsiness; disorientation; loss of balance; nausea; numbness in extremities and face; and difficulty with mental tasks.
The patient's reported that the diagnoses of the occupational health physicians they visited included upper and lower respiratory irritation, intoxication-type syndrome, occupational asthma, and chronic hypersensitivity pneumonitis.
The central nervous system effects reported by many do not lend themselves to ready diagnosis [Ex. 4-282]. Some of the lesser affected individuals either saw no physician at all or saw a family doctor or allergist who was not familiar with occupational or environmental health [Ex. 4-282].
The Air Force Procedural Guide [Ex. 4-199] on dealing with SBS takes a practical view: "* * * in most cases the sick building syndrome does not have a clearly understood etiology and many of the SBS studies and investigations were inconclusive. The significance of exposure that [what chemical or physical agent concentrations cause symptoms] can be pathogenic remains unanswered, but the realities of worker complaints and discomfort are valid reasons to seriously address this problem."
In summary, SBS is not a well-defined disease with well-defined causes. It appears to be a reaction, at least in part due to stimulation of the common chemical sense, to a variety of chemical, physical or biological stimuli. Its victims display all or some of a pattern of irritation of the mucous membranes, and the worst affected individuals have neurological symptoms as well.
B. Building-Related Illness
Building-related illness (BRI) describes specific medical conditions of known etiology which can often be documented by physical signs and laboratory findings. Such illnesses include sensory irritation when caused by known agents, respiratory allergies, nosocomial infections, humidifier fever, hypersensitivity pneumonitis, Legionnaires' disease, and the symptoms and signs characteristic of exposure to chemical or biologic substances such as carbon monoxide, formaldehyde, pesticides, endotoxins, or mycotoxins [Exs. 3-61, 4-144]. Some of these conditions are caused by exposure to bioaerosols containing whole or parts of viruses, fungi, bacteria, or protozoans. These illnesses are often potentially severe and, in contrast to SBS complaints, are often traceable to a specific contaminant source, such as mold infestation and/or microbial growth in cooling towers, air handling systems, and water-damaged furnishings. Symptoms may or may not disappear when the employee leaves the building. Susceptibility is influenced by host factors, such as age and immune system status. Mitigation of building-related illnesses requires identification and removal of the source, especially in cases involving hypersensitivity responses.
1. Indoor Air Contaminants
Comments submitted to the docket in response to the RFI and contained in the literature indicate that specific substances or classes of substances have been implicated as contributing to poor indoor air quality problems. These substances, either alone or in synergy, have produced health effects that OSHA believes can be considered material impairment [Ex. 4-124]. In most cases, people likely to be at risk have specific susceptibility.
But such susceptibility is common and adverse effects can arise suddenly following exposure. The relevant effects can be categorized into six categories: irritation, pulmonary, cardiovascular, nervous system, reproductive, and cancer.
Common chemical sense or irritation perception is mediated through receptors found not only throughout the nasal, pharyngeal, and laryngeal areas of the respiratory system but also on the surface of the eyes, specifically the conjunctiva and cornea [Ex. 4-239]. It is partially through the stimulation of these receptors that exposed persons perceive irritation. Many comments to the docket, from citizens, researchers, and indoor air consultants, raised the issue about the irritating effects related to known indoor air contaminants. The air contaminants of concern include formaldehyde [Exs. 3-14, 3-32, 3-38, 3-188, 3-440a, 3-446, 3-575, 4-125, 4-144, 4-214], volatile organic compounds (VOCs) [Exs. 3-32, 3-446, 3-500, 4-145, 4-243, 4-320], ozone [Exs. 3-14, 4-42, 4-134, 4-236, 4-237], carpet-associated chemicals [Exs. 3-25, 3-444D, 3-576, 4-144, 4-214], vehicle exhausts [Exs. 3-6, 3-63, 3-206, 3-238, 3-360, 3-437, 3-444D, 3-631, 3-659], combustion gases [Ex. 3-32], particulates [Exs. 3-32, 3-446, 3-500], man-made mineral fibers (fiberglass, glasswool and rockwool) [Ex. 4-33], and pesticides [Ex. 3-446]. The irritation effects present as sensory irritation of the skin and upper airways, irritation of eye, nose and throat, dry mucous membranes, erythema, headache, and abnormal taste [Ex. 3-14, 4-33]. The pulmonary effects include upper and lower respiratory tract effects such as rapid breathing, fatigue, increased infection rate, broncho-constriction, pulmonary edema, asthma, allergies and flu-like symptoms. Acute exposure to low level of air contaminants results in primarily reversible effects, while chronic exposure may result in pulmonary fibrosis that can result in irreversible damage [Exs. 3-14, 4-33].
These health effects were associated, as reported in many comments to the docket, with specific contaminants, including asbestos [Exs. 3-38, 3-440A, 3-500], combustion gases [Exs. 3-14, 3-34, 3-440A, 3-446, 3-500], formaldehyde [Exs. 3-32, 3-38, 3-188, 3-440A, 4-124], ozone [Exs. 4-42, 4-237], VOCs [Ex. 3-32], vehicular exhaust [Ex. 3-63], and particulates [Exs. 3-32, 3-38, 3-440A, 3-500].
Individuals with underlying pulmonary disease, such as asthma, are more susceptible than others to acute exposure to these indoor air contaminants and experience coughing and wheezing at low levels of exposure. Synergism may occur between chemical contaminants, such as ozone and VOCs, in aggravating asthma [Ex. 4-33]. These affected individuals may also be at increased risk of pulmonary infections due to the synergistic effect between chemical and microbial contaminants [Ex. 4-33].
Cardiovascular effects have also been associated with poor indoor air quality. These effects are presented as headache, fatigue, dizziness, aggravation of existing cardiovascular disease, and damage to the heart. These effects are associated with exposure to combustion gases such as carbon monoxide [Exs. 3-38, 3-440A], VOCs [Ex. 3-500], and particulates [Ex. 3-500].
Nervous system effects have also been produced due to exposure to poor indoor air quality. These effects include headache, blurred vision, fatigue, malaise with nausea, ringing in the ears, impaired judgement, and polyneuritis. These effects are associated with exposure to carbon dioxide [Ex. 3-14], carbon monoxide [Exs. 3-32, 3-38, 3-446, 3-500], formaldehyde [Exs. 3-32, 3-38, 3-446, 3-500], and VOCs [Exs. 3-32, 3-446, 3-500].
Relevant reproductive effects include menstrual irregularities and birth defects and are associated with exposure to formaldehyde [Exs. 3-446, 3-500] and VOCs [Exs. 3-446, 3-500].
The occurrence of cancer has also been attributed to exposures associated with poor indoor air quality. In particular, cancer of the lung, including mesothelioma, esophagus, stomach, and colon have been associated with exposure to asbestos [Exs. 3-6, 3-14, 3-38, 3-188, 3-440A, 3-500], radon [Exs. 3-35, 3-38, 3-188, 3-440A, 3-500], vehicular exhausts [Exs. 3-84, 3-206, 3-360H], combustion gases [Ex. 3-500], VOCs [Exs. 3-446, 3-500, 4-294], and particulates [Ex. 3-500].
2. Microbial Contamination
Building-related illnesses can result in serious illness and death. Indoor transmission of disease caused by obligate pathogens (microbes that require a living host) is common in indoor environments, especially those that are overcrowded and inadequately ventilated [Ex. 4-33]. Diseases in this category include influenza, rhinovirus or colds, and measles. Indoor transmission of disease caused by opportunistic microorganisms usually affects compromised individuals, those with existing conditions that make them more susceptible to infection, such as pulmonary disease or immunodeficiency. Legionnaires' disease, pulmonary tract infections, and humidifier fever are diseases that fall into this category. Diseases that affect the immune system include allergic reactions, as seen in antibody-mediated responses (asthma and rhinitis) and interstitial lung disease, as seen in cell-mediated reactions (hypersensitivity pneumonitis) [Ex. 4-33]. All of these diseases produce substantial amounts of illness each year [Exs. 4-33, 4-41, 4-214].
In the U.S., Legionnaires' disease is considered to be a fairly common, serious form of pneumonia. The Legionella bacterium is one of the top three bacterial agents in the U.S. which causes sporadic community-acquired pneumonia. Because of the difficulty in clinically distinguishing this disease from other forms of pneumonia, many cases go unreported. Although approximately 1,000 cases are reported to the Centers for Disease Control and Prevention annually, it has been estimated that over 25,000 cases of the illness actually occur. This disease burden is estimated to result in over 5,000 to 7,000 deaths per year [Ex. 4-41]. Brooks et al. [Ex. 4-33] reported that as many as 116,000 cases occur each year. Of these cases, it is estimated that between 35,000 and 40,000 die. The attack rate for L. pneumophila ranges from 0.1 to 5%. The case fatality rate ranges from 15 to 20% [Ex. 4-214].
Two serious allergic or hypersensitivity diseases are asthma and hypersensitivity pneumonitis (extrinsic allergic alveolitis). An estimated 3% of the U.S. population suffers from asthma (approximately 9,000,000 people) [Ex. 4-41]. These individuals may be more susceptible to bioaerosol contamination or chemical contamination of the indoor environment.
Hypersensitivity pneumonitis is triggered by recurrent exposure to microbials, fumes, vapors, and dusts [Ex. 4-33]. The lung interstitium, terminal bronchioles, and alveoli react in an inflammatory process that can organize into granulomas and progress to fibrosis. The symptoms of acute episodes of this disease are malaise, fever, chills, cough and dyspnea. The symptoms of chronic episodes are serious respiratory symptoms such as progressive dyspnea. Chronic disease can lead to irreversible pulmonary structural and functional changes [Ex. 4-33].
Approximately 15% (20,250) of 135,000 hospital admissions per year that last an average of more than eight days are due to allergic disease [Ex. 4-41]. Burge and Hodgson estimate that these hospitalizations cost five million work days per year. The prevalence of symptoms consistent with hypersensitivity pneumonitis, an interstitial lung disease caused by organic dusts or by aerosols has been examined in subpopulations at well-defined, increased risk, such as farmers (0.1-32%) or pigeon breeders (0.1-21%) [Exs. 4-41, 4-214]. The only unbiased source of complaint rates in unselected office workers are control buildings used in the study of hypersensitivity pneumonitis in the U.S. Arnow et al. [Ex. 4-15] reported complaints consistent with hypersensitivity pneumonitis in 1.2 percent and Gamble et al. [Ex. 4-116] in 4 percent of these populations. Since no clinical data are available, it is not known how these complaints are related to actual disease, and it is unknown whether these complaints are associated with lost work time, doctor visits or hospital admissions [Ex. 4-41].
Humidifier fever, a less serious variant of hypersensitivity pneumonitis, also is caused by exposure to microorganisms contained in an aerosol. Attack rates in building epidemics have been as high as 75%, whereas complaint rates are usually 2-3% in nonepidemic situations [Ex. 4-41]. Because of the similarity of the individual symptoms to other diseases (fever, headache, polyuria, weight loss and joint pain), it is often difficult to separate actual disease from complaints related to the common cold in nonepidemic situations [Exs. 4-33, 4-41]. While rare, a workplace epidemic of humidifier fever can virtually shut down an entire building, and only removal of the contamination will end the epidemic [Exs. 4-41, 4-144, 4-214].
Microbial contamination of building structures, furnishings, and HVAC system components contribute to poor indoor air quality problems, especially those related to building-related illnesses. OSHA believes that consequent health effects constitute material impairment of health [Exs. 3-61, 4-41]. These can be categorized as irritation, pulmonary, cardiovascular, nervous system, reproductive, and cancer effects.
Irritation effects, either from the physical presence of bioaerosols or from exposure to VOCs released by biologicals, have been demonstrated in susceptible workers [Ex. 3-32]. In addition, water leakage on furnishings or within building components can result in the proliferation of microorganisms that can release acutely irritating substances into the air. Typically, where microorganisms are allowed to grow, a moldy smell develops. This moldy smell is often associated with microbial contamination and is a result of VOCs released during microbial growth on environmental substrates [Ex. 4-41].
Pulmonary effects which have been associated with exposure to bioaerosols include rhinitis, asthma, allergies, hypersensitivity diseases, humidifier fever, spread of infections including colds, viruses, and tuberculosis, and the occurrence of Legionnaire's disease [Exs. 3-17, 3-32, 3-38, 3-61B, 3-188, 3-440A, 3-446, 3-500, 4-41, 4-144, 4-214].
Building-related asthma has also recently been documented in office workers [Exs. 3-61, 4-43] and some case reports show it to be associated specifically with humidifier use. Biocides used in humidification systems are suspected causes of office-associated asthma [Ex. 4-103].
Cardiovascular effects manifested as chest pain, and nervous system effects manifested as headache, blurred vision, and impaired judgment, have occurred in susceptible people following exposure to bioaerosols [Exs. 3-32, 3-446]. It has been suggested that these effects may be caused by VOCs released by the microbiologicals, or they may be a complication of related pulmonary effects.
The development of cancer in susceptible people is possible following exposure to certain types of toxigenic fungi and mycotoxins. However, the probability of such exposures occurring in workplaces covered by this standard is probably limited. Mycotoxins (toxins produced as secondary metabolites by many fungi) are among the most carcinogenic of known substances, and are also acutely toxic. The American Conference of Governmental and Industrial Hygienists wrote "[t]he toxigenic fungi are common contaminants of stored grain and other food products and have caused well-described outbreaks of acute systemic toxicosis as well as specific organ carcinogenesis when such food is consumed * * * It appears clear that massive contamination with a highly toxigenic fungus strain of a site in which aerial dispersion of metabolic products occurred would be necessary to induce acute symptoms. However, considering the carcinogenicity of many fungal toxins, an examination of the risks of chronic inhalation exposure appears justified" [Ex. 3-61].
In summary, most of the health effects associated with SBS and BRI occur in indoor environments were concentrations of pollutants are much less than the OSHA Permissible Exposure Levels (PELs) (29 CFR 1910.1000) [Ex. 4-3]. It is important to point out that the PELs are chemical-specific standards that are not only based on health effects but also on technological feasibility, cost restraints and a "healthy" worker exposed for a 40-hour work week. In the industrial workplace, hazards are minimized by the use of administrative and engineering controls and the use of personal protective equipment. The nonindustrial environment, however, does not have these controls. Ventilation systems are designed only to remove occupant-generated contaminants, such as carbon dioxide and odors. These types of systems were not designed to dilute multiple point sources of contaminants that are typically found in nonindustrial workplaces (see section III). Unless adequate ventilation and source controls are utilized and adequately maintained, many of the chemical contaminants can concentrate to levels that induce symptoms. The possibility exists that synergistic effects occur. These effects occur not only between substances to enhance their toxicity but also by lowering the resistance to lung infection in susceptible persons.