|Volume 75||Number 4||Winter 1997|
WHEN THE HAZARD IS HUMAN: IRRATIONALITY, INEQUITY, AND UNINTENDED CONSEQUENCES IN FEDERAL REGULATION OF CONTAGION Cite as 75 Wash. U. L.Q. 1367
PAULA E. BERG[*]
The resurgence of infectious disease during the past two decades has been one of the most unexpected, influential, and defining challenges of our time. Notwithstanding the medical profession's mid-century declaration of victory over contagion, recent outbreaks of infectious diseases in the United States, especially Acquired Immune Deficiency Syndrome ("AIDS"), have taken hundreds of thousands of lives and cost billions of dollars. By many accounts, this increasing incidence of emerging and re-emerging infectious disease will continue into the foreseeable future.
One of the most far-reaching effects of the AIDS epidemic on government has been a radical and largely ad hoc expansion of federal involvement in regulating the risk of contagion. The Centers for Disease Control and Prevention ("CDC"), a subsidiary of the Department of Health and Human Services, have issued numerous guidelines to reduce person-to-person transmission of infectious diseases. Additionally, in 1987 the Occupational Safety and Health Administration ("OSHA") catapulted itself into a dominant position in this field when it interpreted its statutory obligation to regulate workplace toxins and hazardous conditions under the Occupational Safety and Health Act (the "Act") to include disease-causing microbes carried by human beings. To date, OSHA has issued permanent standards on the human immunodeficiency virus ("HIV"), hepatitis B ("HBV"), and other bloodborne pathogens ("BBPs"), and it recently proposed a new standard for workplace exposure to people with tuberculosis ("TB").
This article will take a critical look at OSHA and the CDC, which together constitute the federal system responsible for prospective regulation of the risk of contagion in institutional settings. In particular, this article will argue that OSHA's recent inclusion in this regulatory system is highly problematic given the uneasy fit between the substantive and procedural provisions of the Act, geared as they are toward regulating hazardous things, and the task of regulating contagion arising from human beings. The Act was not originally intended to curtail the spread of contagion within the population generally or to protect workers from contracting infectious diseases through workplace contact with microbes carried by other human beings. Rather, it was enacted to reduce the increasing incidence of industrial accidents and work-related disease caused by non-human workplace hazards, specifically dangerous equipment, harmful physical agents, and toxic substances, many of which were associated with new technologies. Neither the statute's language nor its legislative history indicates congressional intent to vest OSHA with the authority to safeguard workers' health by regulating their contact with human beings infected with contagious diseases.
Compared to toxic chemicals and dangerous physical conditions, the regulation of workplace risks posed by human beings implicates a substantially broader and more complex constellation of rights and interests. Because non-human workplace hazards possess no autonomous legal rights, reducing the risks associated with them requires the balancing of only two sets of rights and interests--employees' right to a safe working environment and employers' economic right to control their businesses and maximize profits. Consistent with its limited purpose of reducing non-human workplace hazards, the Act's conceptual structure and rulemaking process take into account and balance these, and only these, two sets of rights and interests.
However, workplace risks posed by human beings infected with infectious disease implicate several additional sets of rights and interests no less deserving of legal protection than employees' health rights and employers' economic rights. These are the civil rights and liberties of persons with an infectious disease ("PWIDs") and persons who are perceived to have an infectious disease ("perceived PWIDs"), and the general public's right to be protected against an unreasonable risk of contagion. When a PWID or a perceived PWID enters a workplace, the complex conflict of rights and interests that arises cannot be rationally and equitably resolved unless all of these rights and interests, not just those of employers and employees, are considered, weighed, and balanced.
This article will demonstrate that substantive and procedural provisions designed to regulate non-human phenomena by balancing two sets of rights, cannot be superimposed on a problem that requires the regulation of human beings and the balancing of multiple sets of rights without generating a panoply of theoretical distortions, regulatory irrationalities, and unintended consequences. The first section will provide an overview of the federal system for regulating contagion, and will describe and analyze the rulemaking process and the content of existing CDC and OSHA regulations. The second and third sections will examine the substantive and procedural provisions of the Act and the culture of OSHA, which together constrain the agency's ability to develop effective and equitable workplace contagion regulations. Finally, the last section will suggest how to reduce irrationality and inequity through reallocating authority to regulate contagion in institutions among the CDC, OSHA, and state public health officials and through OSHA's adherence to certain substantive principles and implementation of a number of procedural changes for regulation in this field.
The CDC, which is a subsidiary of the Public Health Service ("PHS") and the Department of Health and Human Services, is this country's--and the world's--preeminent authority on the epidemiology and prevention of infectious diseases. For most of the CDC's fifty-year history, its activities have primarily consisted of laboratory and field research into the causes of infectious diseases and collecting of surveillance data to assist state prevention and control programs. Since the advent of AIDS, however, a significant portion of the CDC's activities has been devoted to developing and disseminating practical guidelines to prevent the transmission of infectious diseases. Since 1982, the CDC has issued many recommendations on preventing the transmission of HIV, HBV, TB, and other infectious microbes in a wide variety of institutional settings. On several occasions, guidelines have been developed in response to a specific congressional directive.
The CDC does not approach the problem of reducing the risk of occupational transmission of infectious disease by developing generic infection control guidelines applicable to all institutional settings in which a particular infectious agent, such as HIV or M. TB, presents a risk to workers. Instead, the CDC issues site-specific recommendations that include risk reduction measures for specific categories of employees. Additionally, unlike OSHA, which is charged only with protecting workers' health, the CDC's mandate is to protect the public health generally. Consequently, its recommendations typically include measures for preventing transmission to all persons at risk within an institution.
The CDC, however, is not authorized to promulgate enforceable regulations. Consequently, CDC guidelines become enforceable only if they are formally adopted by a state or another federal agency with rulemaking authority, such as OSHA or the Food and Drug Administration ("FDA").
The CDC's lack of authority to promulgate enforceable regulations is a mixed blessing. On the positive side, the CDC's freedom from a congressionally prescribed rulemaking process has enabled the agency to utilize the procedures that it believes are best suited to developing recommendations for preventing the spread of contagious disease. Generally, the agency does not adhere to the notice and comment provisions of the Administrative Procedure Act ("APA"). Instead, the agency employs a consensus-based, expert-oriented approach to rulemaking, which enables it to develop guidelines comparatively quickly and to modify recommendations readily in response to new scientific information. Additionally, unlike agencies such as OSHA, which have formal rulemaking authority, the CDC is not subject to highly specific substantive, procedural, and regulatory analysis requirements that can protract the rulemaking process.
On the other hand, the CDC's dependence on federal agencies, Congress, or the states to imbue its recommendations with the force of law can result in prolonged periods during which workers and others are exposed to an excessive risk of exposure to contagion. Additionally, the CDC's internalized rulemaking largely shields its deliberative process from public scrutiny.
Congress enacted the Occupational Health and Safety Act in 1970 "to assure so far as possible every working man and woman . . . safe and healthful working conditions[.]" Congress vested the Occupational Safety and Health Administration, which is housed within the Department of Labor, with three tools to reduce occupational injuries and death. First, OSHA may issue emergency temporary standards to protect employees from "grave danger." Second, OSHA may promulgate enforceable national standards to assure "to the extent feasible . . . that no employee will suffer material impairment of health or functional capacity[.]" Finally, the Act's General Duty Clause obligates employers to provide places of employment that are "free from recognized hazards that are causing or are likely to cause death or serious physical harm[.]" To enforce its standards and the General Duty Clause, OSHA is authorized to conduct unannounced workplace inspections and to impose civil and criminal penalties upon noncompliant employers.
To set new permanent standards for workplace contagion, OSHA must comply with numerous substantive and procedural requirements contained in the Act and several other statutory and regulatory mandates. To comply with the substantive requirements of the Act, OSHA's creation of a new contagion standard must be predicated upon a finding that an infectious disease presents a significant risk in the workplace that can be eliminated or lessened by a change in practices. While OSHA need not justify contagion standards on the basis of a cost-benefit analysis, it must separately calculate the economic impact of proposed standards on each category of affected employer.
The Act also specifies the procedure that OSHA must follow to set a new standard. OSHA must solicit input from employees, employers, and other interested parties at several stages of the rulemaking process. First, OSHA must draft, publish, and seek public comment on a proposed rule. If objections to a proposed rule are filed, OSHA must schedule public hearings. After considering the information it receives, OSHA must redraft and publish a final rule.
Before issuing a new standard, OSHA must complete an ever-increasing series of risk assessments, feasibility studies, workplace surveys, regulatory and environmental impact analyses, and cost-benefit calculations. Executive Order 12,866, issued by President Clinton in 1993, requires OSHA to quantify and compare the costs and benefits of proposed standards and other available feasible regulatory alternatives. The Small Business Regulatory Enforcement Fairness Act ("SBREFA") requires OSHA to provide Congress with a detailed analysis of each new standard for its review. If Congress passes a joint resolution disapproving of a standard, it cannot take effect until OSHA revises it or the President determines that it is needed to prevent an imminent threat to health or safety. Under the Unfunded Mandates Reform Act of 1995, OSHA must assess the impact of a standard on private sector employers and determine whether it imposes any "unfunded mandates" on state, local, or tribal governments. The Regulatory Flexibility Act requires OSHA to calculate the costs of compliance for small businesses and to assess whether any would be competitively disadvantaged. Finally, OSHA must analyze the new standard's environmental impact.
OSHA depends on outside agencies and experts to perform many of these assessments and other critical functions. The National Institute of Occupational Safety and Health ("NIOSH") and the CDC, both of which are separately housed within the Department of Health and Human Services, supply scientific data and review proposed contagion rules. The Office of Management and Budget ("OMB") must review proposed and final contagion regulations, OSHA must respond to queries, and new standards cannot be issued until the OMB review is completed. Finally, OSHA routinely retains outside consultants to perform mandated risk assessments and economic analyses. To amend a workplace contagion standard, OSHA must again adhere to the substantive and procedural requirements of the Act and all other applicable mandates.
OSHA first entered the field of regulating workplace contagion in 1986 after a coalition of unions representing health care workers ("HCWs") petitioned the agency to develop a permanent standard for bloodborne pathogens. At the time, a panoply of publicly and privately developed guidelines for reducing workplace exposure to bloodborne pathogens were in effect, including some issued by OSHA. Nevertheless, the petitioners argued that enforceable and somewhat broader regulations were needed to adequately protect HCWs against occupational infection. After denying the unions' request for a temporary emergency standard, a work group of OSHA employees decided to promulgate an entirely new standard covering all bloodborne pathogens.
OSHA's assessment of the risk that workers face from exposure to BBPs is premised upon a "zero-exposure approach," which presumes that any workplace exposure to a body fluid poses an unacceptable risk because it can lead to transmission, infection, and illness. In accordance with this assumption, OSHA's BBPs standard broadly applies to all settings where it can be "reasonably anticipated" that an employee's skin, eyes, or mucous membranes may come into contact with blood or other body fluids.
Covered employers are subject to various engineering controls, work practice controls, personal protective equipment requirements, and information-related mandates. Employers must develop and implement an Exposure and Control Plan that identifies all employees at risk and describes the risk-producing functions they perform and the safety measures that have been implemented. Employers must institute work practice controls, including the use of universal precautions ("UPs"), hand washing, use and disposal of needles and sharp instruments, and laundry handling techniques. Employers must offer employees (but may not require that they avail themselves of) the vaccination for hepatitis. All occupational exposures to any bloodborne pathogen must be documented and evaluated, and exposed employees must be informed of the infection status of any person with whom they had contact. Finally, workers must receive education on preventing occupational exposure to BBPs.
In 1993, a coalition of workers' groups petitioned OSHA to set a permanent standard for workplace exposure to people with tuberculosis. The petitioners complained that noncompliance with existing guidelines had led to several recent outbreaks of TB, including one in which a prison guard died from a drug-resistant strain. In response, the OSHA work group that had developed the BBPs standard examined existing protections and assessed whether TB posed a significant and thus regulatable workplace risk. After deciding that an emergency temporary standard was not warranted, and rejecting the option of enforcing existing CDC guidelines, the group decided instead to produce a new permanent standard.
The scope of OSHA's proposed standard for occupational exposure to tuberculosis ("TB Standard") is substantially similar to that of existing CDC recommendations. However, in addition to applying to workplaces covered by site-specific CDC recommendations, such as health care facilities, prisons, drug treatment facilities, and homeless shelters, OSHA's TB Standard also applies to emergency medical services, home health care, home based hospice care, and providers of social work, social welfare, teaching, law enforcement, and legal services in covered work settings.
Employers in covered work settings are subject to varying risk reduction requirements contingent on local infection rates and on whether individuals with "suspected" or "confirmed infectious TB are admitted into the workplace. Employers are subject to all requirements contained in the standard if they (1) admit or provide services to individuals with "suspected or confirmed infectious TB," (2) have encountered a case of confirmed infectious TB within twelve months, or (3) are located in a county that, in the past two years, has had any cases of confirmed infectious TB in one year and at least six cases in the other year. Facilities that meet none of these conditions are subject to a limited program of risk reduction because they are considered to pose a lower risk to employees.
Employers at higher-risk facilities (those that meet any one of the three conditions described above) must develop a written Exposure Control Plan that identifies all employees with potential occupational exposure to TB and that describes risk reduction measures that have been implemented. Additionally, all covered employers must develop procedures to promptly identify individuals with suspected or confirmed infectious TB who seek entry to a facility. The standard does not specify the procedures that employers must use to identify suspected or confirmed cases. Rather, employers are permitted to develop their own identification procedures, which, at homeless shelters, for example, can consist of merely observing persons for symptoms of active TB, such as coughing and sneezing, and obtaining a medical history.
Once a suspected or confirmed case is identified, the standard gives employers at higher-risk facilities two options. Employers may immediately transfer the individual to another facility equipped with acid-fast bacilli ("AFB") isolation rooms. While awaiting transfer, the individual must be masked or segregated from employees. Alternatively, facilities may admit individuals with suspected or confirmed TB and become subject to additional requirements. Individuals with suspected or confirmed infectious TB who are admitted into a workplace must be segregated in an AFB room and thereby separated from employees. Also, engineering controls must be installed in other areas that present a risk of transmission to employees. Finally, employees at these facilities must be told who is infectious and must be provided with respiratory protection to use when they have contact with infectious individuals under circumstances that pose a risk of transmission.
In addition to protecting workers from exposure to TB carried by non-employees, the standard seeks to reduce the risk of worker-to-worker transmission. Employees with possible occupational exposure must be tested for TB when hired, periodically thereafter, and prior to termination. Employers must record exposure incidents and provide medical examinations and treatment to infected workers. If an exposure incident results in occupational transmission, the source individual must be tested to determine whether he or she is infected with a drug-resistant strain. Employees with suspected or confirmed infectious TB must be removed from the workplace until they are no longer infectious, and excluded employees must receive full salary and benefits and be reinstated when they are no longer infectious.
Finally, all employers subject to the standard must provide training to employees about the epidemiology of TB, its signs and symptoms, the modes of transmission, and infection control procedures, including the proper use of personal protective equipment.
As previously stated, the singular objective of the Occupational Health and Safety Act is to reduce job-related employee illness and injury. Consequently, OSHA's authority is limited to imposing risk reduction measures that protect employees' health and safety. The agency cannot impose measures intended to protect the health of non-employees in a workplace or the public health generally. OSHA regulations that seek to accomplish goals, no matter how laudable, other than protecting worker health have been invalidated.
At best, the Act's limited objective results in missed opportunities for government intervention that could protect the public health by reducing the spread of contagious disease among the population. For example, OSHA's TB Standard does not, and indeed could not, require employers to establish on-site clinics at homeless shelters, provide treatment referrals or directly observed therapy ("DOT") for persons determined to have infectious TB, create non-congregate housing, or even educate persons with suspected or confirmed infectious TB about the need for immediate treatment and the risk of transmission--all of which are necessary to stem the spread of TB.
At worst, the Act's restrictive focus on reducing employee health risks can lead to OSHA regulations that actually increase the risk that non-employees in a workplace will be exposed to a contagious disease. For example, OSHA's TB Standard requires employers to either mask individuals with suspected or confirmed infectious TB who are awaiting transfer or to segregate them in a confined area where they will not have contact with employees who are not wearing respiratory protection. Shelters are not required, however, to implement measures to prevent TB transmission among persons confined in these areas, by, for example, mandating that all persons be masked. If unmasked persons who are not in fact infected with TB are confined with unmasked persons who are infectious, transmission is possible. Moreover, segregating unmasked persons with infectious TB together in a confined area creates the risk that they will become superinfected with drug-resistant strains of TB. Additionally, the TB Standard mandates the installation of engineering controls in areas that present a significant risk to employees, but not in areas that present a significant risk to non-employees, such as the congregate sleeping areas of homeless shelters. If persons with infectious TB are mistakenly admitted into congregate areas of a homeless shelter that lack engineering controls, the conditions for the transmission of TB to uninfected patrons are ideal.
The Act's limited focus can also lead to regulations that reduce employees' risk of contagion while increasing the risk of contagion to the population as a whole. For example, OSHA's TB Standard does not precondition a facility's right to transfer a person with confirmed or suspected infectious TB upon finding available accommodations for the individual at another appropriate facility. Thus, an employer could exclude a PWID or perceived PWID and do no more than provide the individual with directions to another facility that in fact is full to capacity. In the case of homeless shelters, this employer prerogative may over the long term cause homeless persons with TB to avoid shelters altogether, and instead to seek shelter in other congregate settings that may be even more conducive to the spread of TB.
Finally, the Act fails to protect many of the employees who face the greatest risk of occupational exposure to infectious disease. In many states, OSHA does not have the authority to impose enforceable standards on public facilities, which tend to provide services to those populations with the incidence of infectious disease is highest. As a result, its capacity to remedy the problem of non-compliance with CDC guidelines, which led to its entry into this regulatory field in the first place, is severely curtailed.
While there is considerable disagreement among scholars about the optimal degree of specificity in an agency's enabling legislation, statutes must, at a minimum, fully articulate Congressional objectives and identify the values that administrators must consider when making policy choices and choosing implementation strategies. Because the Occupational Safety and Health Act's singular goal is to protect worker health, the only values identified within the statute are employee health rights and employer economic rights. While the Act authorizes OSHA to weigh these two sets of values when deliberating on the specific content of standards, Section 6(b)(5) limits these deliberations. Specifically, this section expresses Congress' judgment that, as a general rule, employee health rights should take precedence over employer economic rights. However, by explicitly tempering this principle with the requirement of "feasibility," Congress expressed its value-based determination that employers' economic rights should prevail over employee health rights when the cost of risk reduction measures would cause substantial economic dislocation among affected industries.
While the Act may provide OSHA with an adequate statement of objectives and values for resolving conflicts related to the regulation of workplace toxins and dangerous physical conditions, it does not provide sufficient guidance for regulating contagion. Specifically, the Act's failure to identify any goals other than the protection of employee health (such as the protection of the public health generally) and to explicitly value the rights of other parties affected by contagion regulations creates the risk that OSHA will routinely value the rights and interests of employers and employees at the expense of PWIDs, perceived PWIDs, and the public.
Aspects of OSHA's BBPs and TB standards support this hypothesis. For example, OSHA rejected a program of mandatory vaccination for HCWs against hepatitis, even though the vaccine is 96% effective and safe, because it unduly infringed upon employees' privacy and religious rights. Thus, when faced with a choice between protecting employees against a relatively minimal intrusion upon their privacy and protecting the health of the public, OSHA opted to protect employee rights.
OSHA's contagion standards are significantly less protective of privacy rights, even when the rationale for intrusion is hardly compelling, when the Act does not specifically protect the affected individuals. For example, when an employee has been exposed to a patient's blood, the BBPs standard requires employers to test that blood, if available, for the presence of HIV and HBV and to disclose the results to the employee. Disclosure is also required if a patient's infection status is known to the employer. Employers are not required to obtain a source individual's consent to testing and disclosure in these circumstances unless state law mandates it. Because an employee can determine if she has contracted HIV from a source individual only by being tested herself, learning the serostatus of this individual has little value. Moreover, the CDC recommends that chemoprophylaxis to reduce the likelihood of HIV infection after occupational exposure to blood be initiated one to two hours postexposure. Delaying postexposure chemoprophylaxis until the results of a source individual's HIV test can be obtained is therefore medically contraindicated.
OSHA's TB Standard also reflects the agency's bias toward resolving multi-party conflicts by opting for risk reduction methods that favor the rights and interests of employers and employees. For example, employers' obligation to implement risk reduction measures is conditioned upon whether individuals with suspected or infectious TB are permitted to enter a facility. If they are not, employers are spared from the costliest aspects of the standard, which require the installation of engineering contols and supplying respiratory protection to employees. While this approach accomplishes the goals of protecting employee health and minimizing costs to employers, it creates a strong financial incentive for employers to deny services to individuals with suspected or confirmed infectious TB to avoid the most expensive components of the standard. Indeed, an unintended consequence of OSHA's imposition of fewer obligations on institutions that exclude and deny services to people with TB may be to encourage employers to violate the Americans With Disabilities Act by simply barring individuals with TB, even though reasonable and affordable modifications could eliminate the risk to employees.
OSHA's definition of a suspected case of infectious TB and its approved criteria for identifying these individuals also reflect a bias in favor of the interests of employees and employers. The TB Standard permits employers to identify suspected cases by observing individuals who seek entry to a facility for symptoms, such as sneezing and coughing, and obtaining a medical history. If an intake worker suspects infectious TB, the individual may be denied services and excluded from the workplace. Again, while OSHA's definition of a suspected case and its identification criteria may accomplish the goal of protecting employees at the lowest cost to employers, this approach is likely to lead to the denial of services to many individuals who suffer from respiratory diseases other than TB, particularly at homeless shelters and drug treatment facilities. Indeed, several experts on homelessness have predicted that these criteria could result in the exclusion of nearly all homeless persons from shelters during the winter months when respiratory infections among this population are rampant.
The development of rational and just workplace contagion regulations requires the authority to impose infection controls when any of the quantitative or qualitative risks to the health or civil rights of affected parties, individually or in combination, are unacceptable. For example, the rationale underlying the CDC's concept of universal precautions ("UPs"), under which HCWs treat all patients as if they are infected with HIV, is their furtherance of a multiplicity of rights and interests and their reduction of a combination of unacceptable risks, some of which are quantifiable and some of which are not. Specifically, in addition to reducing the risk that HCWs will contract HIV from the relatively few patients they treat who are HIV-positive, and who therefore present a significant risk, UPs reduce the risk of HCW-to-patient and patient-to-patient transmission. Second, by substantially reducing HCWs' incentive to know which patients are infected with HIV and which are not, UPs reduce the risk that patients' privacy rights will be infringed upon by involuntary testing for HIV. Finally, UPs reduce the risk that PWIDs and members of groups disproportionately infected with HIV, such as gay men and IV drug users, will be denied treatment by HCWs.
The requirement that UPs be employed is not premised on the existence of statistically significant risk that every HCW who comes in contact with a patient's body fluid will actually be exposed to or become infected with HIV. Indeed, in light of the low rates of infection with bloodborne pathogens within the population as a whole and the unique conditions necessary for transmission, HCWs do not face a statistically significant risk of infection with HIV following occupational exposure to patients' body fluids. Thus, it would be very difficult, if not impossible, to justify the CDC's policy of UPs on the narrow basis of a quantitative risk to HCWs.
In contrast, OSHA's authority to impose infection controls is strictly conditioned upon proof by substantial evidence that a workplace presents a statistically significant risk to the health of workers. Risks to other parties, and any qualitative benefits that might result from a change in workplace practices, are irrelevant. While OSHA's risk assessments need not be scientifically certain, courts have invalidated standards that are not supported by quantitative evidence sufficient to establish that a hazard poses a serious risk to workers' health.
The Act's one-dimensional and excessively quantitative significant risk requirement disables OSHA from justifying contagion standards on the basis of a number of risks created by a PWID's presence in the workplace. This generates several adverse consequences. First, because OSHA must justify infection control regulations on the basis of risk to workers alone, the agency must resort to questionable quantitative techniques that overestimate workers' risk of occupational infection and infection-related deaths. These exaggerated risk assessments, in turn, can feed workers' irrational fears of occupational infection and lead to unauthorized infection control measures, such as denying treatment to PWIDs and perceived PWIDs.
In devising its bloodborne pathogens standard, for example, OSHA generally estimated workers' risk of exposure to BBPs without regard to whether they already used personal protective equipment in accordance with existing infection control guidelines. This resulted in overestimates of the reduction in health care worker illnesses and deaths that would result from the standard. As OSHA's own data revealed, the vast majority of vulnerable workers were already using infection control techniques that virtually eliminated their risk of occupational exposure to BBPs. In addition, by calculating occupational risk for BBPs without considering the impact of existing guidelines, OSHA overestimated the risk faced by employees, primarily health care workers, who were already regulated. It thereby failed to establish the Industrial Union Department v. American Petroleum Institute decision's requirement that its new standard was necessary to eliminate a significant risk among these workers.
OSHA also exaggerated non-HCWs' risk of occupational exposure to BBPs. For example, calculations of the risk to non-HCWs (such as lifeguards) of occupational infection with HBV are based on extrapolations from epidemiological data on HCWs. From these, OSHA concluded that both HCWs and non-HCWs faced equal levels of risk. While it is true, as OSHA assumed, that some risk of infection with a BBP arises from any contact with a body fluid, equating the level of risk faced by these two groups disregards the far greater likelihood that HCWs will have contact with body fluids and that the fluids will actually contain an infectious microbe. Additionally, this conclusion conflicts with the surveillance data showing no documented cases of occupational transmission of HIV or HBV among several categories of employees newly subjected to infection control regulations by OSHA's BBPs standard.
OSHA also appears to have exaggerated workers' risk of death from job-related TB, and the number of annual worker deaths that its TB Standard will prevent. To arrive at these calculations, the agency estimated the risk of infection among covered employees. From these data, the agency estimated the excess risk of occupational infection with TB. To calculate the excess risk of death among occupationally infected workers, OSHA estimated the number of infected workers who would progress to active disease and then used national TB fatality statistics to estimate workers' risk of death from TB and the number who die from the disease annually. This methodology led OSHA to estimate that the risk of death from TB is from 0.2 to 3 deaths per 1,000 exposed hospital workers; 3.5 per 1,000 workers in long-term care facilities; 2 per 1,000 workers in home health care; and .5 per 1,000 in home care; and to conclude that the TB Standard will prevent 115 to 136 annual deaths among workers from job-related tuberculosis.
However, OSHA's reliance upon national TB fatality statistics as the basis for calculating the excess risk of death and expected annual fatalities among infected employees is highly questionable. Drug susceptible TB is nearly 100% curable in patients who are immunocompetent and complete the treatment regimen. Fatalities from both drug-susceptible and drug-resistant TB largely occur among individuals who do not receive or complete treatment, are immunosuppressed (primarily due to HIV infection), or are otherwise in poor health. Because the vast majority of HCWs and other employees covered by the TB Standard do not belong to the groups for whom treatments for TB fail, OSHA's estimates of the excess risk of death and preventable deaths are necessarily overstated.
Finally, in addition to encouraging OSHA to produce exaggerated risk assessments that can foster discrimination, the Act's significant risk requirement forces OSHA to spend years and precious resources, which could be devoted to enforcement, and on calculating the statistical risk that every worker subject to the standard faces from exposure to workplace contagion. Indeed, the Act's significant risk requirement is particularly burdensome in the context of regulating contagion, because many highly unpredictable and nonquantifiable variables affect the likelihood of microbial transmission between human beings.
Currently, twenty-one states and two territories have been granted exclusive authority to regulate occupational safety and health issues under OSHA-approved plans. In the remaining jurisdictions, the Supreme Court held in Gade v. National Solid Wastes Management Ass'n that the Act preempts state laws and regulations establishing an occupational safety and health standard on an issue for which OSHA has promulgated a standard. A state regulation in these jurisdictions that has "dual impact" (both an occupational and a nonoccupational purpose) is also preempted if it "directly, substantially, and specifically" regulates workplace safety. Thus, the only way a state regulation that affects worker safety can avoid preemption under Gade is if it is "generally applicable"--that is, it regulates the conduct of workers and non-workers alike as members of the general public--and if it does not conflict with an OSHA standard.
As a consequence of the Supreme Court's decision in Gade, OSHA emerges as the preeminent regulator of the risk of contagion in public and private institutions in states that do not have approved plans. In these jurisdictions, state and local health departments are divested of the authority to issue or enforce infection control regulations for any microbe, such as HIV or TB, for which OSHA has set standards. OSHA contagion standards also supplant CDC recommendations adopted by these states. This is true even if the preempted state laws are more protective of workers and the public than the OSHA contagion standard.
While Gade's transfer of authority for developing institutional infection controls from state health departments to OSHA in states without approved plans achieves the desirable goal of not subjecting employers and employees to duplicative regulations, it raises several very serious concerns. First, state and local public health departments' experience and expertise in contagion control is vastly superior to OSHA's. Second, the state health departments' broad mission to protect the public health generally makes them better suited to regulating contagion than is OSHA with its one-dimensional, worker-oriented perspective. Third, unlike OSHA, state health officials are accustomed to considering the impact of infection control measures on the civil rights and liberties of PWIDs and perceived PWIDS and balancing the interests of all affected parties. Finally, because state health departments routinely collect and analyze surveillance data on contagious disease, they are better able than OSHA to understand the problems of contagion in their states and to tailor regulations to their population's needs.
Gade's extension of OSHA preemption to dual-impact state laws, unless they are of "laws of general applicability," is even more problematic. As others have noted, the meaning of this category is far from clear. Thus, Gade will at best generate considerable confusion about whether OSHA contagion standards supplant state laws on a wide range of issues, such as the testing of employees for infection, the confidentiality of test results, and the rights of employees and non-employees with contagious diseases. If, in fact, courts determine that laws and regulations regarding these matters are not generally applicable and therefore are preempted, the Secretary of Labor and OSHA administrators will irrationally be vested with the ultimate authority to set national standards on a wide range of highly sensitive and controversial civil rights and liberties issues in which they lack expertise and experience, and about which the Act is utterly silent.
Neither is the Occupational Safety and Health Administration and the political environment in which it operates conducive to the production of rational and equitable workplace contagion standards. The notice and comment provisions of the Act presume that OSHA has the internal expertise necessary to develop standards and that input from interested parties will be needed only to fine-tune them. However, because OSHA in fact lacks expertise in infectious disease, epidemiology, and contagion control, it is overly dependent on outsiders for the basic information needed to develop proposed contagion standards.
Moreover, OSHA has historically regulated things, not people. It has no expertise in or experience with assessing the impact of standards on the public health as a whole or on the rights and liberties of parties other than employers and employees. Because the work group responsible for developing OSHA's contagion standards does not include experts on civil rights or public health, these perspectives are relegated to a subordinate position. Indeed, OSHA's failure to request comment on any of these subjects at the outset of its rulemaking for either BBPs or TB suggests that it fails altogether to appreciate the centrality of these concerns to the development of workplace contagion regulations that are rational, just, and effective.
Finally, the political context in which OSHA operates severely constrains its ability to promulgate contagion regulations expeditiously and to enforce standards effectively once they are issued. Nearly every OSHA standard has been challenged and subjected to judicial review, which delays enforcement. The frequency of judicial review has caused the agency to adopt an adversarial rather than a collaborative posture toward rulemaking in general and toward rulemaking on workplace contagion in particular.
This problem is compounded by OSHA's tendency to become the lightning rod during political battles over whether health and safety risks are best reduced by "command-and-control" regulations or by market incentives. When free marketeers gain the upper hand, OSHA's administrative burdens are often increased, even as its budget is cut. Even when the political climate is favorable, OSHA's enforcement budget has always been plainly inadequate to ensure compliance with its contagion standards. Given this bureaucratic reality, OSHA's capacity to substantially reduce employer noncompliance with infection control regulations is dubious.
OSHA's reliance on union petitions to establish its standard-setting priorities for hazardous chemicals has long been criticized. As commentators have noted, this method of agenda- setting fails to ensure that OSHA's limited resources will be concentrated on the workplace toxins and dangerous conditions that pose the greatest risk to workers.
OSHA's reliance on union petitions to set its priorities for regulating workplace contagion is even more problematic. First, it virtually guarantees that contagion standards will take effect long after the greatest risk of occupational infection has passed. Since unions do not track outbreaks of contagious diseases, their perception of the seriousness of workers' risk of occupational exposure to infectious microbes is shaped by the mass media and anecdotal experience. However, rational regulation of contagion requires that risk reduction measures be implemented before a new microbe is sufficiently entrenched that it can generate the number of cases in the general population, and in particular the number of occupational cases, needed to capture the media's and hence unions' attention. By then, the optimal time for government intervention to prevent transmission is long gone.
The timing of union petitions for OSHA standards on bloodborne pathogens and TB illustrates this problem. Unions did not petition OSHA to set a standard for HIV until almost five years after the AIDS epidemic began. Moreover, unions did not petition for a standard for TB until eight years after the United States incidence rate had increased following decades of decline, and one year after it had again been brought under control.
Additionally, OSHA's reliance on unions to set its regulatory priorities over the long term tends to concentrate resources on dramatic but uncommon risks of workplace exposure to infectious disease, while common but undramatic risks remain unregulated. Studies of risk perception demonstrate that the media's tendency to focus on sensational, unusual, and catastrophic risks leads the public to overestimate the occurrence of these hazards. As a result, heavily publicized risks (like AIDS and MDR-TB) often become the focus of public concern and demands for strict regulation, while more mundane risks (like HBV and the common strain of TB) are ignored. Given the fact that these older infectious diseases, as well as long-standing risks from dangerous workplace conditions and hazardous chemicals, are responsible for many more cases of work-related illness and death, the reasonableness of such an approach is questionable.
The failure of unions to petition OSHA to regulate HBV until 1986 supports this argument. Despite high rates of occupational infection with HBV among HCWs, unions did not petition OSHA to regulate this bloodborne pathogen until the highly publicized and dramatic AIDS epidemic of the mid-1980s. By that time, however, HBV had infected between fifteen and thirty percent of HCWs nationwide; it was also killing about 200 HCWs annually.
The burdensome procedural requirements of the Act, and the bevy of other mandates that govern OSHA's standard setting, also ensure that the agency's contagion regulations take effect too late to be of maximum benefit. OSHA cannot summarily adopt existing federal or national consensus standards on infection control as enforceable standards without embarking on its formal rulemaking process. To impose a standard quickly, OSHA must issue an emergency temporary standard and then proceed with formal rulemaking. As a practical matter, however, the criteria for issuing an emergency temporary standard make this option of limited value in regulating workplace contagion.
OSHA's inability to summarily adopt existing CDC or national consensus standards for controlling workplace contagion needlessly delays the implementation of enforceable standards that would offer workers and the public the best protection. However, OSHA exacerbates this problem by regulating the risk of workplace contagion de novo, as if no voluntary or mandatory infection control regulations existed. As previously stated, when the agency received union petitions to develop standards for BBPs and TB, a number of voluntary guidelines for reducing workplace exposure to these microbes were already in effect. OSHA's research revealed that compliance with existing guidelines was high in some industries but low in others. However, rather than propose existing CDC guidelines as permanent standards and concentrate enforcement on industries with low compliance rates, OSHA opted to develop entirely new permanent standards for BBPs and TB. This approach delayed the issuance of enforceable regulations and extended the period during which employees and others in non-complying facilities faced an unnecessarily high risk of infection.
Additionally, OSHA's standard-setting process, which takes from four to eight and one-half years to complete, is simply too protracted to enable the agency to materially reduce workers' risk of occupational infection with a contagious disease. It took OSHA three years to develop its proposed rule on BBPs and another two and one-half years to promulgate its final rule. Judicial review took another year. It took OSHA four years to publish its proposed TB Standard, which, in the end, contained only "minor differences" from existing CDC guidelines.
The incompatibility between OSHA's cumbersome standard-setting process and the objective of reducing the risk of contagion in the workplace leads to several regulatory irrationalities and has several unintended consequences. First, by the time an OSHA contagion standard goes into effect four to five years after the standard-setting process begins, it is highly likely that the risk faced by employees has already decreased significantly. This is primarily because of the efforts of the CDC and public health officials, who can respond much more quickly than OSHA to outbreaks of workplace contagion.
Indeed, by the time OSHA's final TB standard takes effect it may very well be superfluous. Traditional TB control strategies have largely succeeded in reducing the incidence of TB generally during the past few years, thereby reducing the occupational risk faced by employees. Indeed, the CDC reported that new cases of TB in 1996 were at the lowest number and rate since national reporting began in 1953. Additionally, the outbreaks of MDR-TB among workers in hospitals and prisons that prompted OSHA to undertake TB regulation in 1993 have not recurred since the early 1990s, thanks to the expeditious response of the CDC and state and local public health officials. It is highly questionable, therefore, that the additional risk reduction that OSHA's TB standard will achieve will justify the time and resources OSHA has expended. Indeed, OSHA's TB standard lends credence to Justice Stephen Breyer's thesis that the modern regulatory state irrationally expends excessive resources to clean up the "last 10%" of some hazards while others remain wholly unregulated.
Finally, OSHA's entry into workplace contagion regulation may paradoxically increase the risk to workers' health from hazards within the agency's traditional regulatory domain--toxic substances and dangerous physical conditions. OSHA is capable of working on only a few standards at a time because each one consumes a substantial portion of its total resources. While the agency lumbers through the process of developing permanent standards for a contagious disease (which, if prevalent, will already be heavily regulated by the CDC and state health departments), it diverts its resources from any of the hundreds of known and suspected carcinogens and other nonhuman workplace hazards that remain unregulated.
While the law is somewhat unsettled, OSHA apparently has the authority to promulgate generic standards that apply to all workplaces in which workers are exposed to any of a class of substances. The chief advantage of generic rulemaking is that it relieves OSHA of the onerous burden of separately calculating the risk of each substance for each industry.
While generic standard-setting may be desirable for regulating risks caused by non-human workplace hazards, the practice is highly problematic in the context of workplace contagion. First, by not requiring precise industry-by-industry risk assessments, generic rulemaking permits OSHA to include some categories of workers in a standard on the basis of assessments of the risk to other categories of workers. This can lead to overly broad standards that mandate infection controls in workplaces in which there is virtually no risk to employees. In addition to imposing an unjustified economic burden on employers, such standards can also generate misunderstanding among employees and the general population about how particular pathogens are transmitted, and increase fear and stigmatization of the infected.
Second, by not requiring separate risk assessments for each infectious agent, generic rulemaking permits OSHA to equivocate about the level of risk that each type of covered worker faces from exposure to a particular microbe. For example, in its BBPs standard, OSHA sidestepped a precise conclusion about whether dentists and dental workers face a significant risk of exposure to HIV, even though the evidence it gathered established that they do not. Imprecise assessments of the risk posed by a particular microbe hardly help to allay workers' irrational fears of transmission, and like the exaggerated risk assessments encouraged by the significant risk requirement, they may lead to discrimination against PWIDs or perceived PWIDs.
Third, the imprecise risk assessments and overly broad standards that can result from generic rulemaking may contribute to judicial overregulation of the risk of contagion in other legal contexts. For example, OSHA's failure to state that dental workers do not face a significant risk of occupational infection with HIV permitted one state court judge to cite OSHA's BBPs standard as support for his decision to uphold the attempted murder conviction of an HIV-positive inmate for biting a guard. Additionally, overly broad OSHA contagion standards that impose detailed infection control measures on certain industries, despite the absence of a particularized showing of significant risk, may generate judicial overregulation of the risk of contagion in tort actions against employers where violations of OSHA standards are admissible to prove negligence.
Finally, the overly broad contagion standards that can result from generic rulemaking may irrationally enlarge the scope of services that employees can lawfully refuse to provide to PWIDs and perceived PWIDs. Under the Act, employees have the right to refuse to perform tasks if they have a reasonable apprehension of incurring death or serious injury. When OSHA includes categories of workers in contagion standards based on exaggerated and imprecise risk estimates, it expands the services that employees may legitimately deny to PWIDs and perceived PWIDs if employers are not in strict compliance.
Judicial review alone is not an adequate check on irrationality, inequity, and unintended consequences in OSHA contagion standards. As a threshold matter, petitioners seeking to invalidate standards because of their adverse impact on civil rights or the public health may have difficulty establishing standing.
The Occupational Safety and Health Act states that any person who may be adversely affected by an OSHA standard may obtain judicial review. This language, which mirrors that in the APA, seems to imply that standing to obtain judicial review of an OSHA standard is dependent only upon a showing of injury. Consistent with decisions interpreting the APA, however, courts have required plaintiffs challenging OSHA standards to meet the zone of interests test in addition to demonstrating harm.
While the zone of interests test has been construed rather broadly in suits challenging agency actions under the APA, its interpretation in the context of litigation under the Occupational Safety and Health Act has been considerably more restrictive. Specifically, courts have recognized only the interests of employees and employers as falling within the zone protected by the Act. Parties with other interests, who cannot obtain derivative standing on the basis of shared interests with employers or employees, have not succeeded in broaching the courthouse door.
If this narrow interpretation of the zone of interests test is applied to challenges to OSHA contagion standards by public health and civil rights advocates, courts may deny standing to these groups. In addition to foreclosing judicial remediation of contagion standards, this could also lead OSHA administrators to be less protective of these interests during the rulemaking process. It has long been recognized that the prospect of judicial review influences agency decision makers to develop regulations that address the interests of potential legal challengers. Thus, the absence of pressure to address the interests of the infected and the general public may lead to administrative resolutions that are less advantageous to those interests. Specifically, the pressure to meet the demands of employers and employees, and the absence of pressure to address the demands of the infected, may create a general tendency within OSHA to adopt standards that are either over-protective (thereby meeting the demands of employees) or low-cost (thereby meeting the demands of employers) or both (thereby satisfying both groups). Indeed, contagion standards such as the TB Standard that permit employers to exclude PWIDs from the workplace rather than requiring them to install engineering controls necessary to admit and provide services to PWIDs, are generally a relatively low-risk option for OSHA regulators because they satisfy the interests of both employers and employees, its two potential adversaries.
In the event that courts do apply the APA's more liberal zone of interests test and grant standing to civil rights and public health advocates--as they should--OSHA contagion standards are still not likely to be invalidated for being based on imprecise or exaggerated assessments of workers' risk of contagion. With few exceptions, courts do not interpret the Act's substantial evidence test as requiring rigorous scrutiny of OSHA's risk assessment methods or scientific data to unearth shaky assumptions and conclusions, particularly when, if OSHA has erred, it is on the side of overprotecting workers. Indeed, judicial deference to OSHA's judgments and methods is greatest when the agency regulates risks like contagion that are especially difficult to quantify with a high degree of certainty. Absent glaring defects in the record, courts generally defer to OSHA's judgments so long as the agency explains its data, assumptions, and logic and concedes as much when it has been unable to make precise risk estimates.
Moreover, judicial review cannot be relied upon to adequately protect the interests of third parties who are invisible to the substantive structure of the Act and under-represented in the standard-setting process. Absent a blatant conflict with the federal Rehabilitation Act or the Americans with Disabilities Act, courts are unlikely to invalidate contagion standards ad hoc on the basis of exogenous interests and policy considerations. These interests and considerations include the adverse impact on public health or civil rights, provided the statutory requirements of enhanced worker safety, significant risk, and economic and technological feasibility have been met.
Finally, a substantial body of civil rights decisions strongly suggests that judges have great difficulty with managing the risk of contagion in environments that present more than a trivial risk of transmission. In School Board of Nassau County v. Arline, the Supreme Court held that the federal Rehabilitation Act prohibits employers from excluding people with contagious diseases from the workplace unless they pose a "significant risk" of transmitting the disease to others and reasonable accommodation will not eliminate this risk. Consistent with its concept of significant risk in Industrial Union Department v. American Petroleum Institute, the Supreme Court in Arline made clear that assessing whether a risk is significant, and therefore unacceptable, requires consideration of both the probability that the disease will be transmitted and the gravity of the associated harm.
Application of the Arline standard over the past decade demonstrates that federal judges are capable of faithfully applying the significant risk test and deeming a risk acceptable if the scientific evidence establishes that the statistical probability of microbial transmission in a particular setting is virtually nonexistent, and that the contact between the infected and uninfected does not involve a proven route of transmission. However, when confronted with settings such as health care facilities, in which contact with body fluids regularly occurs, judges consistently shrink from conscientiously applying the probabilistic aspect of the significant risk test, even when the scientific evidence establishes that the likelihood of transmission is not significant. Instead, in these cases, judges either routinely lower the critical threshold for measuring statistical significance or ignore this criterion altogether and deem the risk unacceptable because of the gravity of the harm.
This same failed analysis is discernible in the few existing decisions involving OSHA contagion regulations. In American Dental Ass'n v. Martin, the American Dental Association argued that OSHA lacked authority to regulate the dental industry because the agency had not produced substantial evidence that dentists faced a statistically significant risk of contracting HIV and HBV from their patients. OSHA's evidence of dental workers' risk of occupational infection with HIV consisted of one look-back study of twenty-four health care workers that found one HIV-infected dentist. OSHA did not assess dentists' risk of occupational infection with hepatitis at all, choosing instead to rely on aggregated risk estimates for all health care workers.
OSHA's evidence of dentists' risk of occupational infection with bloodborne pathogens was clearly insufficient to meet the substantial evidence and significant risk tests; indeed, analogous defects in the record have led to judicial invalidation of other OSHA standards. Nevertheless, the majority in Martin, consistent with civil rights decisions discounting the probabilistic aspect of the School Board of Nassau County v. Arline standard, held that the risk faced by dentists was significant because it was "nontrivial."
The apparent inability of judges to accept any risk of person-to-person transmission in settings where contact with body fluids regularly occurs is also evident in the Secretary of Labor v. Waldon Health Care Center. In this case, a three-commissioner panel of the Occupational Safety and Health Commission ("OSHC") reviewed citations issued to nursing homes under the General Duty Clause for exposing employees to HBV infection through contact with patients' body fluids. While professing to apply the Supreme Court's significant risk test from Industrial Union Department v. American Petroleum Institute, the Commission held that the Secretary had met the standard because nursing home employees could contract the HBV virus from residents "under other than a freakish or utterly implausible set of circumstances."
A thorough analysis of the origins of judicial intolerance of any risk of microbial transmission in environments in which contact with body fluids regularly occurs is beyond the scope of this article. However, studies of risk perception consistently show that non-experts overestimate the riskiness of hazards that are unfamiliar, have catastrophic consequences, and especially, evoke "dread," that is, fear on a visceral level. Since judges are likely to encounter only a few cases involving contagion in the course of a career, they seldom have the opportunity to develop the level of familiarity and knowledge that can help to bring risk assessments more in line with scientific data.
The judicial assessments of risk in the majority and dissenting opinions in American Dental Ass'n v. Martin suggest the undue influence of "dread." In his majority opinion, Judge Posner describes the patient with HIV and HBV as a "menace" traveling from health care provider to health care provider. In addition to evoking the same miasmic theory of contagion that has been invoked throughout history to justify unwarranted restrictions on PWIDs, this pejorative characterization is at odds with the scientific evidence showing an extremely low probability that patients will transmit HBV or HIV to HCWs. Additionally, Judge Coffey's dissent suggests that the risk of transmission from infected dentists to patients and co-workers justifies the disclosure of employee test results following an exposure incident to employers and prospective patients. However, during the fifteen years of the AIDS epidemic, there has been only one inconclusive case of HIV transmission from an infected dentist to a patient, and none from a dentist to a co-worker. Additionally, there have been no documented cases of HBV transmission from dentist to patient in the past ten years.
In light of judges' deference to OSHA determinations and courts' aversion to accepting any risk of contagion in environments where contact with body fluids regularly occurs, solutions to the problems of irrationality and inequity in OSHA contagion standards are best sought through administrative reforms rather than judicial review.
Given the political, procedural, and substantive constraints that undermine OSHA's ability to develop contagion standards that are rational and equitable, it has been argued that responsibility for risk reduction is best left to the CDC, state and local health departments, professional self-regulation, and market forces. The recent history of TB in the United States, however, illustrates the danger of exclusive reliance on this system. The failure of hospitals and other facilities in which there is a high risk of TB transmission to comply with voluntary guidelines was a significant factor in the increased incidence of this disease generally. Moreover, high rates of employer noncompliance with voluntary infection controls continued even after highly publicized outbreaks of MDR-TB in institutional settings and the deaths of employees.
Additionally, even a cursory analysis of a market approach to risk reduction reveals that this strategy has serious shortcomings in the context of contagion. The linchpins of such an approach are the availability of accurate information about existing risk levels and the existence of free choice on the part of employees and consumers. According to this theory, employees and consumers, if armed with accurate information about a particular setting's riskiness, can demand a "fair" monetary premium for exposure to high levels of risk or "choose" to avoid a setting altogether, thereby creating an incentive for risk reduction by the institution. However, workers and consumers do not have access to accurate information about the existing risk in institutional settings. Information about the number of PWIDs in a particular institutional setting is not generally known, and information that is known is generally protected against disclosure to employees and other third parties. Moreover, employees and consumers of services provided by high-risk facilities may be limited in their ability to avoid workplaces with inadequate infection controls.
There are also strong arguments against relying only on state and local health departments and in favor of vesting a federal agency with the authority to regulate and enforce infection controls nationally. Since contagious diseases do not respect states' geographical boundaries, they pose a national danger that is properly within the ambit of the federal government's responsibility. Additionally, state regulation alone is not likely to control the spread of contagion, because individual states do not make risk reduction a priority until the number of cases of infection among their residents reaches a critical mass. Thus, the migratory nature of contagion necessitates a national perspective and strategy, as well as the authority to implement enforceable regulations in states where the risk is already high (in order to reduce it) and in states where the risk is low but significant (to prevent it from increasing).
However, the current allocation of responsibility among OSHA, the CDC, and state and local health departments for developing and enforcing workplace contagion regulations is irrational and duplicative. To better allocate authority between the federal government and the states, the Act's Savings Clause should, consistent with Justice Souter's dissenting opinion in Gade, be amended to provide that an OSHA contagion standard does not preempt state laws and regulations pertaining to the same disease, unless compliance with both is impossible. This amendment would permit states to supplement OSHA contagion standards with additional or more stringent infection controls, and to retain authority to regulate subjects about which an OSHA standard is silent, such as civil rights and liberties issues affecting PWIDs, perceived PWIDs, and employees.
Additionally, it is grossly inefficient for OSHA to use standard-setting as a remedy for employer noncompliance with CDC guidelines. Instead, OSHA should address noncompliance by aggressively enforcing CDC guidelines pursuant to the Act's General Duty Clause and existing regulations requiring employers to provide personal protective equipment and respirators whenever necessary to protect employee health. Advance notice by OSHA of its intent to enforce CDC guidelines pursuant to these provisions should be sufficient to satisfy employers' due process rights.
To achieve early and widespread compliance with new CDC guidelines, substantial OSHA resources should be devoted to enforcing recommendations shortly after they are issued. To facilitate OSHA's enforcement of its guidelines, the CDC should use language that lends itself to this endeavor, such as using mandatory rather than permissive language to describe employer obligations. Industries in which workers and others face the greatest risk of exposure to contagion, such as health care facilities, should be targeted for early inspection. Inspections, citations, and penalties should be highly publicized to maximize the general deterrence effect.
OSHA should develop entirely new contagion standards only if CDC guidelines are facially inadequate to reduce workers' risk to insignificant levels, or only if a highly publicized and aggressive federal campaign to enforce CDC guidelines does not achieve acceptable compliance levels after a reasonable period of time. If new contagion regulations are needed, OSHA should develop standards for each noncompliant industry, rather than proffering a generic rule.
These criteria for OSHA standard setting in the context of workplace contagion would alleviate a number of current problems. First, they would more rationally allocate OSHA's limited standard-setting resources by ensuring that this expensive and protracted process is invoked only when less costly and more expeditious methods for regulating workplace contagion have proved inadequate. Second, they would provide an incentive for employers to comply voluntarily with CDC guidelines by reserving OSHA contagion standards, and the agency's enforcement regime, for the chronically noncompliant. Third, when standard-setting must be undertaken, its length and complexity would be reduced because fewer industries and workers would be subject to new standards. This, in turn, would reduce the number of industries and workers for which OSHA would have to perform risk assessments, cost-benefit analyses, and regulatory impact evaluations. Finally, the proposed criteria would reduce OSHA's need to utilize generic rulemaking and to rely upon exaggerated and imprecise risk assessments that may increase discrimination against PWIDs and perceived PWIDs.
OSHA's implementation of certain procedural reforms and its adherence to several substantive principles would also serve to reduce the irrationalities, inequities, and unintended consequences that currently attend the development of new standards. As a threshold matter, OSHA should not rely on union petitions to determine priorities in the regulation of workplace contagion. Rather, OSHA should set its own regulatory priorities in accordance with disease surveillance data to ensure that it intervenes to protect workers from significant microbial threats at the beginning of outbreaks, rather than at the middle or end.
Additionally, to ensure that new standards are equitable and do not enhance worker safety at the expense of the public health or unduly restrict civil rights, OSHA's deliberative process must be made more inclusive of public health and civil rights perspectives. OSHA's current practice of relying on public comment and outside advisors for this input is not adequate. Instead, the OSHA work group responsible for contagion standards should be expanded to include a public health and civil rights expert. Also, evaluations of the impact of proposed standards on the public health and civil rights should be routinely performed as part of OSHA's regulatory impact analysis process, and these assessments should be included in the record.
Adherence to several substantive principles would enhance the rationality and fairness of OSHA's contagion standards. As previously stated, once OSHA determines that a risk is significant, the principles of economic and technological feasibility are the only constraints on the agency's standard-setting pursuant to section 6(b)(5) and its selection of particular risk reduction measures. However, since adverse effects on civil rights and the public health are no less antithetical to rational regulation of workplace contagion than economic hardship to affected industries, standards with such effects should be similarly regarded by OSHA administrators as not feasible and violative of section 6(b)(5). Courts, too, should apply this interpretation of the feasibility requirement when reviewing OSHA contagion standards, irrespective of the petitioner's identity.
In particular, OSHA contagion standards should be regarded as not feasible if they seek to reduce workers' risk of occupational infection with a contagious disease to a level that is lower than that tolerated for other workplace hazards. Additionally, contagion regulations should not be considered feasible if they permit employers to discriminate against PWIDs in the absence of a finding of significant risk that is individualized and scientifically based.
Concerns about equity, in addition to determining risk acceptability, must guide OSHA's choices among alternative risk reduction measures. In general, when selecting among competing regulatory options to reduce a significant risk to workers' health, OSHA should, when possible, choose the measure that protects all relevant interests--employee health, public health, and the civil rights of third parties--rather than only employees' interests. For example, requiring the installation of ultraviolet lights, which kill or inactivate airborne M. TB, throughout homeless shelters would serve the interests of both employees and residents without imposing an inordinate financial burden on employers. Measures such as this, which serve the interests of employees, the infected, and the public, will withstand judicial review unless they threaten affected industries' survival.
When a solution that satisfies the interests of these parties is inconceivable or not technologically or economically feasible, OSHA's choices among competing rights and interests should be governed by the concept of reasonable accommodation and the related notion of less restrictive alternatives. Workplace contagion standards that infringe upon PWIDs' privacy rights ought to be deemed feasible only if there is a compelling rationale and no less restrictive alternative. Additionally, contagion regulations should not be considered feasible if they restrict PWIDs' rights despite the existence of a less restrictive regulatory alternative that achieves a comparable level of worker safety. This approach would, for example, generally require OSHA to mandate the installation of engineering controls and employee vaccinations if they are safe, effective, and affordable rather than permit employers to exclude or segregate PWIDs. Indeed, in Kohl v. Woodhaven Learning Center, the Eighth Circuit stated that all at-risk staff members of a mental health facility needed to be vaccinated against HBV to reasonably accommodate a resident who was an active carrier of the disease.
Finally, as previously stated, when regulations leave employers or employees to their own devices in making risk assessments, or when they do not mandate anti-discrimination education for employers and employees, increased discrimination against members of historically disfavored groups is a foreseeable unintended consequence. Therefore, feasibility under the Act must also be judged by whether workplace contagion standards include adequate precautionary measures to ensure that day-to-day decisions about risk acceptability and risk reduction are equitable. Specifically, contagion standards must include explicit, detailed, individualized, and scientifically based criteria for determining risk acceptability and they must require that employers and employees receive anti-discrimination education.
[*] Associate Professor of Law, City University of New York Law School; J.D., Rutgers University School of Law; B.A., Hampshire College. I am grateful to my colleagues Stephen Loffredo and Ruthann Robson for their comments on an earlier draft; to Gina Goldstein for her patience and editing; and to Joanna Piepgrass, Sean Marshall Phelan, and Jacquelyn Woodworth for their assistance with research.
[1.] Infectious diseases are caused by pathogens such as bacteria and viruses that are transmitted through air, water, food, animals, or human contact. See STEDMAN'S MEDICAL DICTIONARY 868-69 (26th ed. 1995). This article is concerned only with the subset of these diseases that are transmitted through immediate or mediate contact with an infected human being. For a description of these routes of transmission, see Draft Guideline for Infection Control in Health Care Personnel, 1997, 62 Fed. Reg. 47,276, 47,277 (1997). The terms infectious and contagious will be used interchangeably to refer to such diseases.
[2.] See generally LAURIE GARRETT, THE COMING PLAGUE: NEWLY EMERGING DISEASES IN A WORLD OUT OF BALANCE (1994).
[3.] This optimism was based on the discovery of antibiotics in the 1940s and of a polio vaccine in the 1950s. For an excellent description of this period and its impact on the response of government and the medical establishment to the AIDS epidemic. See id.
[4.] In addition to Acquired Immune Deficiency Syndrome ("AIDS"), there has been a significant increase in the incidence of tuberculosis ("TB") and hepatitis B in the United States during the past 25 years. See Centers for Disease Control and Prevention, The Role of BCG Vaccine in the Prevention and Control of Tuberculosis in the United States, 45 MORBIDITY & MORTALITY WKLY. REP. 1, 2, No. RR-4 (1996) [hereinafter Centers for Disease Control, BCG Vaccine] (general resurgence of incidence of TB in United States from 1985 to 1992, including outbreaks of multidrug-resistant TB ("MDR-TB") in health care facilities and prisons); see Centers for Disease Control, Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination, 40 MORBIDITY & MORTALITY WKLY. REP. 1, 1, No. RR-13 (1991) [hereinafter Centers for Disease Control, Hepatitis B Virus] (rates of acute hepatitis B increased 37% in the United States from 1979 to 1989; 1-1.25 million Americans now potentially infectious).
[5.] The AIDS epidemic was not detected until 1980-81, when young, previously healthy gay men in Los Angeles and New York City were diagnosed with Pneumocystis carinii pneumonia ("PC pneumonia") and Kaposi's sarcoma ("KS"), rare diseases that were previously seen only in patients with severely compromised immune systems. See Centers for Disease Control, Kaposi's Sarcoma and Pneumocystis Pneumonia Among Homosexual Men--New York City and California, 30 MORBIDITY & MORTALITY WKLY. REP. 250 (1981); Centers for Disease Control, Pneumocystis Pneumonia--Los Angeles, 30 MORBIDITY & MORTALITY WKLY. REP. 249 (1981). For an exhaustive history of the emergence of the AIDS epidemic in the United States and worldwide, see GARRETT, supra note 2, at 281-389.
[6.] Between 1980 and 1992, there was a 22% increase in deaths from infectious diseases other than AIDS. See Robert W. Pinner et al., Trends in Infectious Diseases Mortality in the United States, 275 JAMA 189, 191 (1996). As of July 1, 1997, in the U.S., a total of 612,078 AIDS cases and 374,656 AIDS-related deaths had been reported to the Centers for Disease Control and Prevention. See Centers for Disease Control and Prevention, 9 HIV/AIDS SURVEILLANCE REP. 5, 14 (1997).
[7.] The AIDS epidemic has cost the United States billions of dollars for medical care alone. See Fred J. Hellinger, Forecasting the Medical Care Costs of the HIV Epidemic: 1991-1994, 28 INQUIRY 213, 223 (1991) (estimated cost of treating all people with HIV in 1991 is $5.8 billion and $10.4 billion in 1994); Dennis P. Andrulis, The 1987 US Hospital AIDS Survey, 262 JAMA 784, 784 (1989) (estimated cost of AIDS inpatient care in 1987 was $486 million, with Medicaid as the primary payer). These figures do not account for the lost wages, lost tax revenues, and other economic losses associated with this disease.
[8.] "The history of our time will be marked by recurrent eruptions of newly discovered diseases[;] . . . epidemics of diseases migrating to new areas[;] . . . diseases which become important through human technologies[;] . . . and diseases which spring from insects and animals to humans, through manmade disruptions in local habitats."). Jonathan M. Mann, Preface, in GARRETT, supra note 2, at xi; see also Joshua Lederberg, Infection Emergent, 275 JAMA 243, 244 (1996) (at minimum, prospect is for rising exposure to familiar infectious agents and increasing treatment failure with antibiotics). To address this problem, the Centers for Disease Control's funding to track and prevent infectious diseases other than AIDS was increased 41% for fiscal year 1997. David Nather, Senate Takes Up Spending Package After GOP Reaches Deal With White House, BNA HEALTH CARE DAILY, Oct. 1, 1996, at d2.
[9.] Before AIDS, state public health officials had nearly exclusive responsibility for regulating contagion. Federal activity in this area was essentially limited to preventing the introduction of contagion into the country and controlling its spread between the states. See 42 U.S.C. §§ 243, 264 (1994) (authorizing creation and enforcement of regulations to prevent spread of contagion into country and between states, including quarantines). Additionally, before AIDS, the federal Centers for Disease Control's activities were primarily confined to research and disease surveillance. See discussion infra at note 29 and accompanying text.
[10.] On October 27, 1992 the Centers for Disease Control changed its name to "Centers for Disease Control and Prevention," however, it retained its well-known acronym "CDC". Throughout this article "CDC" will refer to the organization under both its old and new name. Through its subsidiaries the CDC, the National Institute of Health ("NIH"), and the National Institute for Allergic and Infectious Disease ("NIAID"), the Department of Health and Human Services' primary responsibility in this area is to conduct research and to make grants to state and non-profit agencies for research related to the treatment, control, and prevention of contagious diseases. See 42 U.S.C. §§ 241(a)(2)-(3), 241(c), 247b, 247c, 281 (1994).
[11.] For a history of the CDC's role in developing infection control guidelines, see Verla S. Neslund et al., The Role of the CDC in the Development of AIDS Recommendations and Guidelines, 15 LAW, MED. & HEALTH CARE 73 (1987).
[12.] In this article, the Occupational Safety and Health Act will be referred to as "the Act" while the Occupational Health and Safety Administration will be referred to as "OSHA."
[13.] OSHA is charged with ensuring that workplaces do not expose workers to unacceptable health and safety risks. See Occupational Safety and Health Act of 1970, 29 U.S.C. §§ 651-678 (1994). The Act authorizes OSHA to promulgate standards dealing with "toxic materials or harmful physical agent[s]." Id. § 655(b)(5).
[14.] OSHA's entry into the field of regulating contagion has received mixed reviews. See Helen M. Schinag, The Occupational Safety and Health Administration's Bloodborne Pathogen Standard: An Important First Step Toward Protecting Employees From the Risks of Occupational Exposure, 17 SETON HALL LEGIS. J. 541 (1993) (OSHA's bloodborne pathogens standard will protect health care workers and others who face occupational exposure from considerable risks faced daily). But see American Dental Ass'n v. Martin, 984 F.2d 823, 831-32 (7th Cir. 1993) (Coffey, J., concurring in part, dissenting in part) (OSHA's bloodborne pathogens standard unduly burdens health care employers with marginal risk reduction for employees); David R. Cherrington, The Race to the Courthouse: Conflicting Views Toward the Judicial Review of OSHA Standards, 1993 BYU L. REV. 95 (1994) (OSHA's bloodborne pathogens standard is economically burdensome on employers and offers little risk reduction benefits to employees).
[15.] Bloodborne Pathogens Standard, 29 C.F.R. § 1910.1030(b) (1996) (including HIV in definition of bloodborne pathogens).
[16.] See id. (including HBV in definition of bloodborne pathogens). Hepatitis B is caused by the hepatitis B virus ("HBV"), which damages and can destroy the liver. See Martin, 984 F.2d at 824. Like HIV, HBV is transmitted by infected body fluids. See id. Unlike HIV, HBV can survive outside the body and thus can be transmitted by contact with unsanitized laundry and surfaces. See id. About 1% of people infected with HBV die; 6% to 10% fully recover but become lifelong carriers, and 89% to 93% fully recover and do not remain infectious. See id. For a detailed discussion of the etiology, epidemiology, and treatment of HBV infection, see EDUARD KURSTAK, VIRAL HEPATITIS: CURRENT STATUS & ISSUES (1993).
[17.] See 29 C.F.R. § 1910.1030(b) (1996) (defining "bloodborne pathogens" and "other potentially infectious materials" both of which the standard regulates).
[18.] See Occupational Exposure to Tuberculosis, 62 Fed. Reg. 54,160 (1997) (to be codified at 29 C.F.R. § 1910) (proposed Oct. 17, 1997). Tuberculosis ("TB") is caused by Mycobacterium tuberculosis ("M. TB"), which is transmissible when a person with active TB coughs or sneezes and sends droplet nuclei containing the bacteria into the air. Centers for Disease Control, National Action Plan to Combat Multidrug-Resistant Tuberculosis, 41 MORBIDITY & MORTALITY WKLY. REP. 5, 5, No. RR-11 (1992) [hereinafter Centers for Disease Control, National Action Plan]. Transmission can occur if an uninfected person is exposed to these airborne bacteria for a prolonged period of time. See id. Only about 10% of people with healthy immune systems who are infected with M. TB will develop active TB and become infectious sometime during their lifetimes. See id. Persons with compromised immune systems have a much greater likelihood of developing active disease and becoming infectious. See Lawrence O. Gostin, The Resurgent Tuberculosis Epidemic in the Era of AIDS: Reflections on Public Health, Law, and Society, 54 MD. L. REV. 1, 14 n.67 (1995). There is a 10% risk annually that people infected with HIV, which impairs the immune system, will develop active TB and become infectious. See id. at 14. The standard treatment protocol for active TB is three to four oral antibiotics taken for six months. See id. at 27. Nearly 100% of immunocompetent persons with active TB who complete this regimen are rendered non-infectious. See id.
[19.] While OSHA's authority is limited to regulating workplaces, the agency in effect has the authority to regulate contagion in every institutional setting, since every institution in which there is interaction between people who are and are not infected with a contagious disease is a workplace.
[20.] See infra notes 21-25 and accompanying text.
[21.] None of the occupational diseases expressly mentioned throughout the Act's legislative history is caused by microbes carried and transmitted by human beings. Specific examples include cancer, asbestosis, byssinosis, and respiratory ailments caused by industrial materials and processes. See SENATE COMM. ON LABOR AND PUBLIC WELFARE, OCCUPATIONAL SAFETY AND HEALTH ACT OF 1970, S. REP. NO. 1282, at 142, 142-43 (1940), reprinted in 1970 U.S.C.C.A.N. 5177, 5178-79. Additionally, all of the data in the legislative history supporting the need for the Act pertain to industrial accidents and diseases arising from exposure to non-human workplace hazards. See id. at 142-44.
[22.] See id. at 153.
[23.] None of the "harmful physical agents" mentioned in the Act's legislative history is a microbe carried and transmitted by human beings. Specified examples are severe noise and vibration. See id. at 143.
[24.] None of the "toxic substances" expressly mentioned in the Act's legislative history is a microbe carried and transmitted by human beings. See id. Cited examples are carcinogenic chemicals, lasers, ultrasonic energy, beryllium metal, epoxy resins, and pesticides. See id. at 142.
[25.] In urging the enactment of OSHA, President Nixon referred to the mixed blessing of technological progress and the need to provide workers with up-to-date protection against the unintended side-effects of industrial innovation. See id. at 144-45.
[26.] OSHA's promulgation of its bloodborne pathogens ("BBPs") and TB standards under § 655(b)(5) of the Act suggests that the agency interprets the phrase "toxic materials or harmful physical agents" in this section of the Act to include infectious microbes carried by human beings. See Occupational Exposure to Bloodborne Pathogens, 56 Fed. Reg. 64,004, 64,004 (1991) (codified at 29 C.F.R. § 1910.1030) (BBPs standard promulgated pursuant to § 655(b)); Occupational Exposure to Tuberculosis, 61 Fed. Reg. 23,271 (1996) (announcing OSHA's intention to promulgate TB standard pursuant to § 655(b)).
[27.] Infectious disease disproportionately affects sexual, racial, and ethnic minorities, poor people, and IV drug users. See Centers for Disease Control and Prevention, First 500,000 AIDS Cases-United States, 1995, 44 MORBIDITY & MORTALITY WKLY. REP. 849, 850, 852 tbl. 1 (1995) [hereinafter Centers for Disease Control and Prevention, First 500,000 AIDS Cases--United States] (rates of AIDS cases six and three times higher among African-Americans and Hispanics, respectively, than among whites; IV drug users and men who have sex with men accounted for 25% and 50.8%, respectively, of total AIDS cases from 1981 to October 1995). Centers for Disease Control, Hepatitis B Virus, supra note 4, at 3 (prevalence of hepatitis B infection among African-American adults and adolescents three to four times greater than prevalence among whites); Gostin, supra note 18, at 37-47 (resurgence of TB greatest among poor, ethnic and racial minorities, homeless, and people infected with HIV); Karen H. Rothenberg & Elizabeth C. Lovoy, Something Old, Something New: The Challenge of Tuberculosis Control in the Age of AIDS, 42 BUFF. L. REV. 715, 722 (1994) (approximately 70% of all TB cases occur among ethnic and racial minorities due to crowded substandard housing, homelessness, substance abuse, and limited access to health care). For currently identified and new infectious microbes, this disparity is likely to continue unless prevention strategies are adequately funded and widely adopted and until the problems of poverty, drug addiction, and inaccessible and inadequate health care are addressed. See Gostin, supra note 18, at 49-50 (high rate of persons in United States living in congregate settings, especially correctional facilities and nursing homes, creates ideal conditions for outbreaks of infectious disease); Peter A. Selwyn, Tuberculosis in the AIDS Era: A New Threat From An Old Disease, 91 N.Y. ST. J. MED. 233, 235 (1991) (effective control of infectious disease cannot be accomplished without addressing underlying social and economic causes). The prevalence of infectious disease among these disfavored groups, who already may be regarded as threatening because of their "otherness," increases the danger that minority group members will be perceived to be infectious, even if they are not, and as a result will be excluded from environments where they are perceived to pose an unacceptable threat.
[28.] See Centers for Disease Control and Prevention, History of the CDC, 45 MORBIDITY & MORTALITY WKLY. REP. 526, 526 (1996) [hereinafter Centers for Disease Control and Prevention, History of the CDC] (calling CDC "an institution synonymous around the world with public health").
[29.] See id. For a detailed history of the CDC, see ELIZABETH W. ETHERIDGE, SENTINEL FOR HEALTH: A HISTORY OF THE CENTERS FOR DISEASE CONTROL (1992).
[30.] Neslund et al., supra note 11 at 73.
[31.] See, e.g., infra notes 33 and 35.
[32.] In 1988, Congress ordered the Secretary of Health and Human Services to transmit the CDC's guidelines on reducing health and public safety workers' risk of occupational exposure to HIV to the Secretary of Labor for use in developing a new permanent OSHA standard. 42 U.S.C. § 300ee-2 (1988). In 1990, Congress enacted the Ryan White Comprehensive AIDS Resources Emergency ("CARE") Act, which amended the Public Health Service Act to include provisions related to the exposure of emergency response employees to infectious disease. 42 U.S.C. §§ 300ff-81-300ff-90 (1990). In accordance with this amendment, the CDC developed a list of potentially life-threatening infectious diseases to which emergency response employees may be exposed; guidelines describing circumstances that present a risk of exposure; and guidelines for medical facilities to determine whether such an exposure has occurred. See Implementation of Provisions of the Ryan White Comprehensive AIDS Resources Emergency Act Regarding Emergency Response Employees, 59 Fed. Reg. 13,418 (1994).
[33.] See, e.g., Centers for Disease Control, Acquired Immune Deficiency Syndrome (AIDS): Precautions for Health-Care Workers and Allied Professionals, 32 MORBIDITY & MORTALITY WKLY. REP. 450 (1983) [hereinafter Centers for Disease Control, AIDS Precautions for Health-Care Workers] (CDC recommendations for preventing HIV transmission among health-care workers and allied health professionals); Centers for Disease Control, Acquired Immune Deficiency Syndrome (AIDS): Precautions for Clinical and Laboratory Staffs, 31 MORBIDITY & MORTALITY WKLY. REP. 577 (1982) [hereinafter Centers for Disease Control, AIDS Precautions for Clinical and Laboratory Staffs, 31 MORBIDITY & MORTALITY WKLY. REP. 577 (1982) [hereinafter Centers for Disease Control, AIDS Precautions for Clinical and Laboratory Staffs] (first set of CDC guidelines on preventing HIV transmission among clinical and laboratory workers in hospitals).
[34.] See generally Centers for Disease Control and Prevention, History of the CDC, supra note 28.
[35.] See, e.g., Centers for Disease Control and Prevention, Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Facilities, 1994, 43 MORBIDITY & MORTALITY WKLY. REP. 1, No. RR-13 (1994) [hereinafter Centers for Disease Control and Prevention, Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Facilities] (recommendations for preventing transmission of tuberculosis in health care facilities include measures for protecting patients and workers).
[36.] The CDC attributes its authority to issue guidelines to the section of its enabling legislation that authorizes the Public Health Service to provide "practical application" of its research on disease prevention. 42 U.S.C. § 241(a)(1) (1994). See Neslund et al., supra note 11, at 78.
[37.] For example, a majority of states adopted the CDC's 1991 guidelines for preventing the transmission of HIV and HBV from infected health care workers ("HCWs") to patients after Congress threatened to cut off federal public health monies to states that did not enact these or equivalent regulations. See Pub. L. 102-141, § 633, 105 Stat. 876, 876 (1991).
[38.] See Mary Anne Bobinski, Risk and Rationality: The Centers for Disease Control and the Regulation of HIV-Infected Health Care Workers, 36 ST. LOUIS U. L.J. 213, 243 n.116 (1991) (CDC asserts that it does not have rulemaking authority and therefore need not adhere to Administrative Procedure Act). Recently, however, the CDC has employed a notice and comment procedure for some recommendations. See, e.g., Draft Guideline for Infection Control in Health Care Personnel, 1997, 62 Fed. Reg. 41,276 (1997) (seeking comments on CDC's draft guidelines for infection control in health care personnel).
[39.] The CDC issued its first set of guidelines on preventing HIV transmission among laboratory and hospital workers in November of 1982, which was within only six months of receiving sufficient evidence to conclude that AIDS was caused by a bloodborne agent. See Neslund et al., supra note 11 at 73-4.
[40.] When the CDC issued its first set of guidelines to prevent health care workers from contracting AIDS from their patients in 1982, HIV had not yet been identified as the causative agent for the disease, and the antibody test to detect infection with the virus had not yet been developed. In response to increased scientific understanding of HIV, the CDC has periodically updated its guidelines for preventing occupational transmission of HIV. For a detailed analysis of the evolution of the CDC's guidelines for preventing HIV and HBV transmission between HCWs and patients, see Bobinski, supra note 38.
[41.] Since it has no formal rulemaking authority and is not subject to the notice and comment requirements of the Administrative Procedures Act, the CDC is not subject to Executive Order No. 12,866, 58 Fed. Reg. 51,735 (1993), which requires agencies to conduct regulatory impact analyses for review by the Office of Management and Budget ("OMB"), or to the Regulatory Flexibility Act, 5 U.S.C. §§ 601-612 (1994), which requires agencies to calculate the costs of compliance for small businesses, or to the Small Business Regulatory Enforcement Fairness Act ("SBREFA"), 5 U.S.C.A. § 801 (1997), or the Unfunded Mandates Reform Act of 1995, 2 U.S.C.A. §§ 1501-1571 (1997). For an analysis of the impact of these requirements on OSHA's development of contagion standards, see infra notes 56-65 and accompanying text.
[42.] The most notorious example of this problem was the failure of the FDA, which regulates the blood industry, to adopt the CDC's recommendations for maintaining the safety of the nation's blood supply in the early years of the AIDS epidemic. In February 1983, the CDC recommended that all blood collection facilities screen all blood for hepatitis. This screening would also have eliminated at least two-thirds of donations tainted with HIV. However, the FDA chose not to adopt the CDC's recommendation. Instead, the FDA waited until 1985 to recommend the use of the HIV test, and until 1988 to order its use. Countless lives were lost between 1983 and 1985 because of the CDC's lack of authority to issue enforceable regulations. For a detailed analysis of the FDA's response to HIV, see Linda M. Dorney, Comment, Culpable Conduct With Impunity: The Blood Industry and the FDA's Responsibility for the Spread of AIDS Through Blood Products, 3 J. PHARMACY & L. 129 (1994); Ross D. Eckert, The AIDS Blood Transfusion Cases: A Legal and Economic Analysis of Liability, 29 SAN DIEGO L. REV. 203 (1992); GARRETT, supra note 2, at 313-15.
[43.] In response to criticism from AIDS organizations, the CDC has increasingly incorporated into its deliberative processes individuals who reflect the perspectives of those affected by its risk reduction recommendations. For example, in 1993, the CDC developed an unusually successful and culturally sensitive model for stemming a hantavirus outbreak in the southwestern United States with the help of Native Americans. See Centers for Disease Control and Prevention, History of the CDC, supra note 28, at 530. See also Neslund et al., supra note 11 at 75-6.
[44.] 29 U.S.C. § 651(b) (1970).
[45.] Id. § 655(c)(1). Emergency temporary standards, which are effective immediately upon publication in the Federal Register, remain in effect for six months. See id. § 655(c)(1)-(3). Thereafter, if OSHA elects to promulgate a permanent standard, the emergency temporary standard serves as the proposed rule. See id.
[46.] Id. § 655(b)(5). The Act requires employers and employees to adhere to OSHA standards and orders. See id. § 654(a)-(b).
[47.] Id. § 654(a)(1).
[48.] See id. § 657.
[49.] See id. §§ 659, 666. If an employer contests a citation, a hearing must be held before the Occupational Safety and Health Review Commission ("OSHRC"), the agency's adjudicatory arm. See id. § 659(c).
[50.] See Industrial Union Dep't v. American Petroleum Inst., 448 U.S. 607, 642 (1980).
[51.] The Act commands OSHA to set the standard that "most adequately assures, to the extent feasible . . . that no employee will suffer material impairment of health or functional capacity[.]" 29 U.S.C. § 655(b)(5) (1994). In American Textile Manufacturers Institute v. Donovan, 452 U.S. 490, 512-14 (1981), the Supreme Court held that, while this language does not require OSHA to perform cost-benefit analyses, it must establish that compliance by employers is economically manageable and technologically achievable. To meet this requirement, OSHA must estimate the cost of compliance for each industry affected by the standard. For example, OSHA estimated that compliance with its BBPs standard would cost all affected industries a total of $813 million annually. See Occupational Exposure to Bloodborne Pathogens, 56 Fed. Reg. 64,004, 64,063 (1991) (codified at 29 C.F.R. § 1910.1030). Of this total, approximately $785 million would be borne by the health care industry; $26 million by law enforcement and fire and rescue operations; $5 million by correctional facilities; $6 million by schools; and $500,000 by lifesaving operations. See id.
[52.] OSHA sometimes goes beyond its statutory duty to obtain public input. For example, OSHA held "stakeholder meetings" with professional groups, labor unions, and trade associations to solicit reactions to a draft proposal on tuberculosis before releasing a proposed rule. See Occupational Exposure to Tuberculosis, 61 Fed. Reg. 62,103, 62,103 (1996).
[53.] See 29 U.S.C. § 655(b)(2) (1994). This step is often preceded by OSHA's issuance of an Advanced Notice of Proposed Rulemaking, which summarizes its preliminary risk assessment, solicits public comment, and describes how the agency intends to proceed. See, e.g., Occupational Exposure to Hepatitis B Virus and Human Immunodeficiency Virus, 52 Fed. Reg. 45,438 (1987) (codified at 29 C.F.R. § 1910).
[54.] See 29 U.S.C. § 655(b)(3) (1994). Between September 1988 and January 1990, over 400 people participated in public hearings on OSHA's proposed standard for bloodborne pathogens in Washington, D.C., Chicago, New York, Miami, and San Francisco. See Occupational Exposure to Bloodborne Pathogens, 56 Fed. Reg. at 64,008.
[55.] See 29 U.S.C. § 655(b)(4) (1994). Judicial review of a standard must be sought within 60 days after the final rule is issued. See id. § 655(f).
[56.] Exec. Order No. 12,866, 58 Fed. Reg. 51,735 (1993).
[57.] See id. § 1(a). For a detailed analysis of Executive Order 12,866, see Richard H. Pildes & Cass R. Sunstein, Reinventing the Regulatory State, 62 U. CHI. L. REV. 1 (1995). For a detailed analysis of the process of regulatory analysis generally, see Thomas O. McGarity, Regulatory Analysis and Regulatory Reform, 65 TEX. L. REV. 1243 (1987).
[58.] 5 U.S.C.A. § 801 (1997).
[59.] See id. § 801(a)(B)(i). OSHA's analysis of its TB standard pursuant to the requirements of SBREFA appear at Occupational Exposure to Tuberculosis, 62 Fed. Reg. 54,160, 54,214-32 (1997) (to be codified at 29 C.F.R. § 1910) (proposed Oct. 17, 1997).
[60.] See 5 U.S.C. § 801(B)(1)-(2) (1994).
[61.] See id. § §801(c)(1)-(2)(1)(A) (1994).
[62.] 2 U.S.C.A. §§ 1501-1571 (1997).
[63.] See id. § 1501(7).
[64.] 5 U.S.C. §§ 601-612 (1994). OSHA's calculations of the impact of its BBPs standard on small businesses appear at Occupational Exposure to Bloodborne Pathogens, 56 Fed. Reg. 64,004, 64,085-86 (1991) (codified at 29 C.F.R. § 1910.1030). OSHA's calculations of the impact of its proposed standard on TB on small businesses appear in Occupational Exposure to Tuberculosis, 62 Fed. Reg. 54,160, 54,220-21 tbl. VII-6 (1997) (to be codified at 29 C.F.R. § 1910) (proposed Oct. 17, 1997).
[65.] OSHA must analyze the environmental impact of its standards in accordance with the provisions of the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. §§ 4321-4370d (1994 & Supp. I 1995); the Council on Environmental Quality NEPA regulations, 40 C.F.R. § 1500 (1996); and the Department of Labor's NEPA Compliance Procedures, 29 C.F.R. § 11 (1996).
[66.] OSHA's housing within the Department of Labor and NIOSH's and CDC's housing within the Department of Health and Human Services can cause delays and coordination problems during this review process. See Sidney A. Shapiro & Thomas O. McGarity, Reorienting OSHA: Regulatory Alternatives and Legislative Reform, 6 YALE J. ON REG. 1, 7 (1989).
[67.] Interview with Claudia Thurber, Project Attorney, Occupational Health and Safety Administration, Washington, D.C. (April 11, 1996) [hereinafter Thurber Interview].
[68.] The Office of Information and Regulatory Affairs ("OIRA"), within the Office of Management and Budget, is specifically responsible for reviewing all regulatory impact statements and final rules. See Exec. Order No. 12,866 § 1(b)(12)(b), 58 Fed. Reg. 51,735 (1993). A proposed standard may be returned to OSHA for further consideration if the OIRA determines that it is inconsistent with the Act, with the President's priorities, the principles contained in the order, or with the policies or actions of another agency. See id. § 6(b). To expedite this process and make OMB's review less secretive, Executive Order 12,866 specifies a time frame for review and requires public disclosure. See id. Commentators have criticized both delays and other aspects of the OMB's regulatory review process that are not addressed by Executive Order 12,866. See Erik D. Olson, The Quiet Shift of Power: Office of Management & Budget Supervision of Environmental Protection Agency Rulemaking Under Executive Order 12,291, 4 VA. J. NAT. RESOURCES L. 1, 43 (1984) (OMB philosophically biased against command and control regulation); McGarity, supra note 57, at 1271-1317 (describing problems inherent in regulatory review process); Alan B. Morrison, OMB Interference with Agency Rulemaking: The Wrong Way to Write a Regulation, 99 HARV. L. REV. 1059 (1986) (OMB review places decisions in the hands of administrators with no expertise in the subject matter of regulations).
[69.] An outside consultant was retained to assess the impact on small businesses of the standard on BBPs. Additionally, in 1993, OSHA published its preliminary conclusion that tuberculosis posed a significant, and therefore regulatable, risk. See Occupational Exposure to Tuberculosis, 59 Fed. Reg. 20,643 (1994). A year later, however, it announced that it had retained several outside experts, including one from the CDC, to assist it with risk assessment. See Occupational Exposure to Tuberculosis, 60 Fed. Reg. 59,625 (1995) The other three risk assessors for tuberculosis were from academia. See id.
[70.] See 29 U.S.C. § 655(b) (1994).
[71.] See Occupational Exposure to Hepatitis B Virus and Human Immunodeficiency Virus, 52 Fed. Reg. 45,438, 45,438-39 (1987) (codified at 29 C.F.R. § 1910). The petitions were filed by the American Federation of State, County and Municipal Employees ("AFSCME"), the Service Employees International Union, the National Union of Hospital and Healthcare Employees, and RWDSU Local 1199--Drug, Hospital and Healthcare Union. See id.
[72.] Between 1982 and 1986, the CDC issued infection control guidelines to reduce occupational exposure to HIV and HBV among clinical and laboratory staffs, health care workers and allied health professionals, and dentists and dental workers. See Centers for Disease Control and Prevention, Recommended Infection-Control Practices for Dentistry, 1993, 42 MORBIDITY & MORTALITY WKLY. REP. 1 (1993) [hereinafter Centers for Disease Control and Prevention, Recommended Infection--Control Practices for Dentistry]; Centers for Disease Control, AIDS Precautions for Health-Care Workers, supra note 33; Centers for Disease Control, AIDS Precautions for Clinical and Laboratory Staffs, supra note 33.
[73.] The American Hospital Association ("AHA") and the American Occupational Medical Association ("AOMA") had also issued voluntary guidelines for reducing occupational exposure to HIV. See Occupational Exposure to Hepatitis B Virus, 52 Fed. Reg. at 45,438.
[74.] In 1983, OSHA issued voluntary guidelines, which were distributed to health care employers, to reduce worker exposure to hepatitis. See id. The guidelines included recommendations for risk-reducing work practices and the use of immunoglobulins and the HBV vaccine. See id. Additionally, OSHA's General Duty Clause and several non-specific regulations (such as the one requiring personal protective equipment) also protected workers from occupational exposure to bloodborne pathogens. See id.
[75.] The unions' demands of OSHA were rather modest. In particular, they requested that work practice guidelines issued by the CDC be enforced and that employers be required to provide HBV vaccines to employees at no cost, to provide training and counseling to employees at risk, and to post isolation precautions in patient areas. See id. Instead of responding to these specific requests, OSHA elected to promulgate an entirely new standard. See id. at 45,349.
[76.] See id. at 45,439.
[77.] Thurber interview, supra note 67.
[78.] According to OSHA:
[E]ach exposure is associated with a unique risk which is the same for anyone exposed to the virus and depends upon the virulence of the pathogen, the size of the delivered dose, the route of exposure, among other factors, and not upon any prior exposure. Thus, in the case of bloodborne diseases, the best way to reduce the risk of transmission is by reducing exposure.
potential disease state in which an individual is known, or with reasonable diligence should be known, by the employer to have one or more of the following conditions, unless the individual's condition has been medically determined to result from a cause other than TB: (1) To be infected with M. tuberculosis and to have the signs or symptoms of TB; (2) To have a positive acid-fast bacilli (AFB) smear; or (3) To have a persistent cough lasting 3 or more weeks and 2 or more symptoms of active TB (e.g., bloody sputum, night sweats, weight loss, fever, anorexia).
disease state that has been diagnosed by positive identification of M. tuberculosis from body fluid or tissue through positive culture, positive gene probe, or positive polymerase chain reaction (PCR). The disease state must be capable of being transmitted to another individual (e.g., pulmonary or laryngeal TB or extrapulmonary TB where infected tissue is exposed and could generate droplet nuclei).
Any State which, at any time, desires to assume responsibility for development and enforcement therein of occupational safety and health standards relating to any occupational safety or health issue with respect to which a Federal standard has been promulgated . . . shall submit a State plan for the development of such standards and their enforcement.
Any person who may be adversely affected by a standard issued under this section may . . . file a petition challenging the validity of such standard with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such standard . . . . The determinations of the secretary shall be conclusive if supported by substantial evidence in the record considered as a whole.
Standing to obtain judicial review of agency action is a critical determinant of a party's ability to participate effectively in the agency's decisionmaking process. Agencies' administrators recognize that they must respond to arguments made by parties that can challenge policy decisions in court, but they can ignore with relative impunity arguments made by parties that lack that power.
Miasma is not a scientific theory, it is not alternative science, but it works like a causal theory about transmission of infection, a basis for prediction and explanation, a guide for action. ...
... The mere physical presence of the unwanted Other is dangerous. Their use of the same space and times and their breathing the common air is a menace to the rest of the community. ... See also Paul Slack, Responses to Plague in Early Modern Europe: The Implications of Public Health, 55 SOC. RES. 433, 437 (1988):[M]iasma could also be transported--in the clothes, bedding, baggage of infected people, or on their persons. It could be picked up from the proximity of the sick and absorbed through the pores of the healthy. Theories of miasma and contagion were thus combined . . . The sick and anything connected with them should be avoided.
[301.] See supra note 289. For an analysis of judicial opinions involving AIDS, see Michael C. Musheno et al., Court Management of AIDS Disputes: A Sociolegal Analysis, 16 LAW & SOC. INQUIRY 737, 767 (1991) (use of emotionally laden language to describe people with AIDS reflects cultural bias and fear of AIDS felt by judges possessing limited knowledge).
[302.] See Martin, 984 F.2d at 840-43.
[303.] See Occupational Exposure to Bloodborne Pathogens, 56 Fed. Reg. 64,004, 64,020-21 (1991) (codified at 29 C.F.R. § 1910.1030).
[304.] Transmission of HBV from dentists to patients has not been reported since 1987. See Centers for Disease Control and Prevention, Recommended Infection-Control Practices for Dentistry, supra note 72, at 2.
[305.] See Martin, 984 F.2d at 847-48 (Coffey, J., concurring in part, dissenting in part).
[306.] The obligations of professional organizations do not extend to the public as a whole, but rather to their members, who may or may not view protecting the public from contagion as a priority. For example, despite the increasing threat from emerging and re-emerging infectious diseases, the American Hospital Association ("AHA") eliminated its infection control division in response to members' demand that greater organizational resources be focused on the changing nature of the health care system. See 4 BNA HEALTH L. RPTR. 1832 (1995).
[307.] "The transmission of TB in health care facilities has been primarily caused by incompete implementation of recommended TB infection control measures." Draft Guideline for Infection Control in Health Care Personnel, 1997, 62 Fed. Reg. 47,276, 47,288 (1997). See also Gostin, supra note 18, at 79 (hospital noncompliance with CDC guidelines responsible for outbreaks of TB among patients).
[308.] An OSHA study found that only 29% of high-risk facilities inspected between 1992 and 1994 had respiratory protection programs for preventing occupational TB. See High-Risk Facilities Not Fully Complying with OSHA TB Guidance, Study Finds, 5 Health L. Rep. (BNA), at 633, 633 (Apr. 25, 1996). This study lends support to Professor Howard Latin's argument that there is little reason to believe that industries will, as a general matter, voluntarily adopt risk reduction measures that involve large capital outlays. See Howard Latin, Ideal Versus Real Regulatory Efficiency: Implementation of Uniform Standards and Fine-Tuning Regulatory Reforms, 37 STAN. L. REV. 1267, 1293 (1985).
[309.] For a discussion of market approaches to regulating occupational risks, see Elinor P. Schroeder & Sidney A. Shapiro, Responses to Occupational Disease: The Role of Markets, Regulation, and Information, 72 GEO. L.J. 1231 (1994).
[310.] See id. at 1237 (efficient distribution of risk of occupational disease requires that employers and employees have complete and equal information about level of risk).
[311.] See McGarity & Shapiro, supra note 213, at 605 (amount of wage premium sought by employees for hazardous work a function of knowledge of existing risks).
[312.] Accurate data on the risk of contagion in an institutional setting can only be obtained through mandatory testing and disclosure.
[313.] Given the likelihood of discrimination against PWIDS and perceived PWIDS, it is not desirable for this information to be readily available to employees and other third parties.
[314.] Patients, for example, cannot readily avoid hospitals in which there is an unreasonably high risk of contagion, particularly if they are seeking care for emergency conditions. Additionally, it is questionable whether employees in many high-risk institutions, such as hospitals, homeless shelters, and prisons, have the bargaining power needed to obtain wage premiums for exposure to high levels of contagion, or job mobility if such efforts prove unsuccessful. See Schroeder & Shapiro, supra note 309, at 1241 (inability of many workers to leave risky jobs defeats wage premium theory); McGarity & Shapiro, supra note 213, at 607 (workers without job mobility have no bargaining power to obtain wage premium for hazardous work).
[315.] See American Dental Ass'n v. Martin, 984 F.2d 823, 848 (7th Cir. 1993) (Coffey, J., concurring in part, dissenting in part) (arguing that state agencies should regulate infection control in health care facilities).
[316.] For example, despite small but steady increases in TB cases in New York City during the late 1970s and 1980s, city and state public health officials did not focus on the problem until it reached crisis proportions in the early 1990s. See Karen Brudney & Jay Dobkin, Resurgent Tuberculosis in New York City, 144 AM. REV. RESPIRATORY DISEASES 745, 748 (1991) (analyzing history of local public health officials' failure to make adequate commitment to strategies for controlling resurgence of TB in 1980s). However, this problem was due in part to the failure of the federal government to provide adequate financial support for state TB control efforts. See id.
[317.] Currently, the Savings Clause states that the Act does not supersede or affect workers' compensation laws; common law or statutory rights, duties, or liabilities under any law with respect to injuries, diseases, or deaths in the workplace; and state laws on occupational safety and health issues about which no federal standard is in effect. See 29 U.S.C. §§ 653(b)(4), 667(a) (1994).
[318.] See Gade v. National Solid Wastes Management Ass'n, 505 U.S. 88, 117 (1992) (Souter, J., dissenting) ("preemption will occur only when actual conflict between a federal regulation and a state rule renders compliance with both impossible").
[319.] See 29 C.F.R. § 1910.132(a) (1996) (employers must provide employees with personal protective equipment if necessary to protect against recognized hazard); 29 C.F.R. § 1910.134(a)(2) (1996) (employers must provide respirators if needed to protect employee health). The chief disadvantage of relying on the General Duty Clause to reduce the risk of occupational infection is that OSHA bears significant litigation burdens in contested cases. Specifically, in such cases, OSHA must prove, among other things, the existence of a recognized hazard at the particular workplace. See Bunge Corp. v. Secretary of Labor, 638 F.2d 831, 835 (5th Cir. 1981). However, this burden can be readily met in cases involving industries that are the subject of CDC infection control guidelines. See Secretary of Labor v. Megawest Fin. Inc., 1995 WL 383233, at *9 (O.S.H.R.C. June 19, 1995) (CDC publication warning employers about homicides in the workplace relevant to determining whether workplace violence is a recognized hazard under the General Duty Clause); Secretary of Labor v. ARA Living Centers of Texas, Inc., 1990 WL 358197 (O.S.H.R.C. Dec. 5, 1990).
[320.] See ARA Living Centers, 1990 WL 358197, at *5 (notices issued by OSHA and the Department of Health and Human Services of intent to enforce CDC infection control guidelines sufficient to afford due process to employer).
[321.] Additionally, workers should be encouraged to report violations of CDC standards to OSHA. Section 660(c)(1) of the Act protects employees against retaliation for reporting hazardous workplace conditions. See Marshall v. Commonwealth Aquarium, 469 F. Supp. 690 (D. Mass. 1979) (employer violated Act by terminating employee who reported health hazard to NIOSH).
[322.] A number of studies have shown that OSHA inspections and penalties have both a specific and general deterrence effect. See Ann P. Bartel & Lacy Glenn Thomas, Direct and Indirect Effects of Regulation: A New Look at OSHA's Impact, 28 J.L. & ECON. 1, 25 (1985) (OSHA enforcement significantly affects industry violation rates); Wayne B. Gray & John T. Scholz, Does Regulatory Enforcement Work? A Panel Analysis of OSHA Enforcement, 27 LAW & SOC'Y REV. 177, 198 (1993) (22% decline in workplace injuries in firms inspected after three years); John T. Scholz & Wayne B. Gray, OSHA Enforcement and Workplace Injuries: A Behavioral Approach, 3 J. RISK & UNCERTAINTY 283, 302 (1990) (finding that increased OSHA enforcement has significant specific and general deterrence effects); W. Kip Viscusi, The Impact of Occupational Safety and Health Regulation, 17 RAND J. ECON. 567, 578 (1986) (finding significant effect on lost-workday incidence data). But see John W. Ruser & Robert S. Smith, Reestimating OSHA's Effects: Have the Data Changed?, 26 J. HUM. RESOURCES 212, 234 (1991) (finding little evidence that OSHA inspections in early 1980s reduced lost workday rates).