Regulations (Preambles to Final Rules) - Table of Contents|
| Record Type:||Occupational Exposure to Bloodborne Pathogens|
| Title:||Section 3 - III. Events Leading to the Final Standard|
III. Events Leading to the Final Standard
Hepatitis B virus (HBV) has long been recognized as a pathogen capable of causing serious illness and death. Because the virus is transmitted through blood and certain body fluids, persons who come in contact with blood and other potentially infectious materials as the result of carrying out their duties have been at increased risk of contracting HBV. The human immunodeficiency virus (HIV), the virus that causes AIDS, has only been recognized in the last decade. Because the transmission of HIV is considerably less efficient than HBV, the risk of HIV infection to employees who must handle blood and other potentially infectious materials is less than for HBV infection (i.e., HIV results in fewer seroconversions following exposure incidents). The consequences of HIV infection are grave, however, because HIV causes the fatal disease AIDS.
Although OSHA has no standard that was designed specifically to reduce occupational exposure to these viruses, the Agency has a number of existing regulations that apply to this hazard. For example, 29 CFR 1910.132 requires employers to provide personal protective equipment and 29 CFR 1910.145 (f) requires accident prevention tags to warn of biological hazards. In addition, section 5 (a)(1) the General Duty Clause of the Act requires that each employer:
furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.
In 1983, OSHA issued a set of voluntary guidelines designed to reduce the risk of occupational exposure to hepatitis B virus (Ex. 4-25). The voluntary guidelines, which were sent to employers in the healthcare industry, included a description of the disease, recommended work practices, and recommendations for use of immune globulins and the hepatitis B vaccine.
On September 19, 1986, the American Federation of State, County and Municipal Employees (AFSCME) petitioned OSHA to take action to reduce the risk to employees from exposure to certain infectious agents (Ex. 2A). They requested that OSHA issue an emergency temporary standard (ETS) under section 6(c) of the Act. The petitioners also requested that OSHA immediately initiate a section 6(b) rulemaking that would require employers to provide the HBV vaccine at no cost to employees at risk for HBV infection and would require employers to follow work practice guidelines such as those issued by the Centers for Disease Control. AFSCME also requested that OSHA amend the Hazard Communication Standard (48 FR 53280) to require a training program for employees exposed to infectious diseases, require counseling for pregnant employees about diseases that have reproductive effects, and mandate posting of isolation precautions in patient areas and in contaminated areas.
On September 22, 1986, the Service Employees International Union, the National Union of Hospital and Healthcare Employees, and RWDSU Local 1199-Drug, Hospital and Healthcare Union petitioned the Agency to promulgate a standard to protect healthcare employees from the hazard posed by occupational exposure to hepatitis B virus (Ex.3). They requested that, as a minimum, the standard should contain all of the provisions in OSHA's 1983 guidelines with special emphasis on making workers aware of the benefits of vaccination. In addition, they asked OSHA to immediately issue a directive stating that employers must provide the HBV vaccine free of charge to all high risk healthcare workers.
Having determined that the available data did not meet the criteria for an ETS as set forth in section 6(c) of the Act, Assistant Secretary John A. Pendergrass denied the petitions by letter dated October 22, 1987. OSHA further determined that the appropriate course of action was to publish an Advance Notice of Proposed Rulemaking (ANPR) to initiate rulemaking under section 6(b) of the Act and to collect further information. Concurrently with the collection of this information, the Agency committed to enforcing existing regulations and section 5(a)(1) of the Act in healthcare settings and to undertaking an educational program in cooperation with the Department of Health and Human Services.
The enforcement program has resulted in reduction of risks for certain workers but, in general, is not a sufficient long-term response to the hazards presented by bloodborne pathogens. The General Duty Clause of the Act requires that each employer shall:
furnish to each of his employees employment and a place of employment which are free from recognized hazards causing or likely to cause death or serious physical harm.
To prove a violation of Section 5(a)(1) OSHA must prove, among other things, that a serious hazard is recognized by the employer's industry or the employer. Kelly Springfield Tire Co., Inc. v. Donovan, 729 F.2d 317, 321 (5th Cir. 1984). OSHA must also prove there is a feasible and useful method for abating the hazard. National Realty & Const. Co. v. OSHRC and Secretary, 489 F.2d 1252 (D.C.Cir. 1973).
Among the abatement methods listed in the Section 5(a)(1) part of the OSHA instruction are Hepatitis B vaccination, training on the hazards of bloodborne pathogens and universal precautions, and follow-up procedures after an HIV or HBV exposure incident. The standards discussed in the OSHA instruction include 29 C.F.R. 1910.132(a), requiring personal protective equipment where there is exposure to hazards, under which OSHA has required the use of gloves and gowns, among other things, where there is exposure to blood and potentially infectious body fluids; 29 C.F.R. 1910.22(a), requiring places of employment to be kept clean and in a sanitary condition, under which OSHA requires the use of certain disinfectants following initial clean up of blood or potentially infectious body fluids; 29 C.F.R. 1910.141(a)(4)(i) and (ii), which requires the use of a non-leaking waste containers and the removal of wastes in such a manner to avoid creating a menace to health, under which OSHA prohibits the recapping of needles by hand and requires the use of puncture-resistant sharps containers, among other things; and 29 C.F.R. 1910.145(f), which requires tags or other means of identification where employees are exposed to potentially hazardous conditions, under which OSHA mandates biological hazard tags or red bagging for bags or other receptacles containing articles contaminated with potentially infectious material. Because most of these standards are broadly worded, and apply only where there is a "hazard", OSHA must generally prove that a reasonable person familiar with the circumstances surrounding an allegedly hazardous condition, including any facts unique to a particular industry, would recognize a hazard warranting the use of personal protective equipment. General Dynamics Corp. v. OSHRC, 599 F.2d 453, 464 (1st Cir. 1979).
To flesh out the requirements of the General Duty Clause and the General Industry Standards, OSHA has relied on guidelines adopted by the Center for Disease Control. (Exs. 6-153; 6-316).
Although the current OSHA enforcement program has reduced the risks of occupational exposure to bloodborne pathogens to some extent, significant risks remain and the Agency has concluded that an occupational health standard promulgated under section 6(b) of the Act will much more efficiently reduce these risks. First, the OSH Act intends that OSHA issue occupational health standards to make clear what is necessary to protect employees, to inform employers of their specific obligations. Standards developed through the rulemaking process with its opportunity for public comment lead to increased protection for employees and easier enforcement as the standards reflect expert opinions, comments from affected parties and scientific findings, all of which are part of the rulemaking record. Second, a standard is more protective of employee health than an enforcement program that is based upon a general provision; consequently, greater reduction of significant risks are achieved. The standard requires more abatement methods than those required by the General Duty Clause and the General Industry Standards. Third, because the standard is much more specific than the current requirements, employers and employees are given more guidance in carrying out the goal of reducing the risks of occupational exposure to bloodborne pathogens. Fourth, the general duty clause and the cited general industry standards impose heavy litigation burdens on OSHA. In each contested case under the current enforcement program OSHA must generally prove that a recognized hazard exists at a particular workplace. In enforcing this standard, which specifies both the conditions which trigger the application of the standard and the abatement obligations, the standard presumes the existence of the hazard and no independent proof of the hazard, i.e. the potential infectivity of blood and certain other body fluids, in the particular workplace need be presented. Furthermore, OSHA need not prove the feasibility of abatement methods where a standard, such as this one, specifies the abatement methods. The reduction in litigation burdens will mean that the Labor Department, as well as the employer, will save time and money in litigation cases. Finally, since states with OSHA-approved state-plans are not required to adopt general duty clauses (29 U.S.C. 667(e)) and thus are not mandated to require the bloodborne pathogen abatement methods which Federal OSHA now requires under Section 5(a)(1) (although they are strongly encouraged to do so), employees in state-plan states which do not require these abatement methods are denied protection because, generally, Federal OSHA does not conduct enforcement in these states. Since state-plan states are required to adopt standards at least as effective as Federal OSHA standards (29 U.S.C. 667(c)), the promulgation of this standard will result in increased protection for these employees.
On October 30, 1987, the Departments of Labor and Health and Human Services published a Joint Advisory Notice entitled, "Protection Against Occupational Exposure to Hepatitis B Virus (HBV) and Human Immunodeficiency Virus (HIV)" (52 FR 4181). In the cover letter to employers, Secretaries Brock and Bowen urged the "widest possible adherence to the appropriate precautions as exemplified by the CDC guidelines and the Joint Advisory Notice."
The letter, notice and a pamphlet written by OSHA for healthcare workers were mailed to more than 600,000 employers, employee representatives and trade and professional associations.
On November 27, 1987, OSHA published in the Federal Register an ANPR announcing the initiation of the rulemaking process (52 FR 45438). The Agency requested information relevant to reducing occupational exposure to HBV and HIV under section 6(b) of the OSH Act. The public was asked to comment on the scope, the modes of controlling exposure, personal protective equipment, vaccination programs, management of exposure incidents, medical surveillance, training and education, generic standards, advances in hazard control, effectiveness of alternative approaches and the environmental effects. A sixty day period was set for comments, and these comments were to be submitted to the OSHA docket by January 26, 1988, as noted in a correction published in the Federal Register December 11, 1987 (52 FR 47097).
OSHA received an overwhelming response to the ANPR. Interested parties included employers, unions, health professionals, trade representatives, professional associations, manufacturers, and government agencies. The comments were analyzed and the data along with other information in the record were used in preparing a Notice of Proposed Rulemaking (NPRM).
On May 30, 1989, OSHA published the NPRM in the Federal Register (54 FR 23042). In it, the Agency made a preliminary determination that certain employees face a significant health risk as the result of occupational exposure to blood and other potentially infectious materials because they may contain bloodborne pathogens, including hepatitis B virus which causes Hepatitis B, a serious liver disease, and human immunodeficiency virus, which causes AIDS. The Agency also preliminarily concluded that this significant health risk can be minimized or eliminated using a combination of engineering and work practice controls, personal protective clothing and equipment, training, medical follow-up of exposure incidents, vaccination, and other provisions.
Public hearings on the proposed standard were held in Washington, D.C., September 12-27, 1989; Chicago, Illinois, October 17-20, 1989; New York City, November 13-16, 1989; Miami, Florida, December 19-22, 1989; and San Francisco, California, January 9-17, 1990. OSHA presented 10 expert witnesses in the areas of Hepatitis B vaccination programs, infection control, clinical laboratories, hazardous waste, training, engineering controls including equipment design and needlesticks, HBV and HIV research and production facilities, and public safety officers' risks. Over 400 persons, representing the wide range of interested parties including healthcare providers, labor unions, trade and professional organizations, and other affected parties participated in the hearings. At the close of the last public hearing on the proposed standard in San Francisco, January 17, 1990, Administrative Law Judge James Guill set the following deadlines for participants to send material to OSHA: March 20, 1990, for the submission of additional information and April 19, 1990, for submission of comments, summations and briefs. These dates were extended to April 19, 1990, for additional information and May 21, 1990, comments, summations and briefs. In addition, comments from any interested persons or organizations on OSHA's surveys relating to the technological and economic feasibility of implementing the proposed standard in hospital and non-hospital facilities were solicited and required to be postmarked on or before May 21, 1990 (54 FR 10250).
The record of the public hearing includes the following: the original transcript of the hearing, which incorporated the record as a whole; exhibits number 24 to 220, which were received into the record during the hearing; exhibits number 221 to 313, which were received as post-hearing comments; Federal Register notice, 55 FR 10250, extending the comment period and notifying the public of information in the record; and Judge Guill's order of July 23, 1991, receiving the post-hearing submissions and closing and certifying the record of the public hearing in accordance with 29 CFR 1911.17. Copies of materials contained in the record may be obtained from the OSHA Docket Office, Room N-2625, U.S. Department of Labor, 200 Constitution Avenue, N.W., Washington, D.C. 20210. The Docket Office is open to the public from 10:00 a.m. until 4:00 p.m., Monday through Friday except Federal holidays.
The final standard on occupational exposure to Bloodborne Pathogens is based on full consideration of the entire record of this proceeding, including materials discussed or relied upon in the proposal, the record of the informal hearing, and all written comments and exhibits received.
Regulations (Preambles to Final Rules) - Table of Contents|