Regulations (Preambles to Final Rules) - Table of Contents|
| Record Type:||Occupational Exposure to Bloodborne Pathogens|
| Title:||Section 7 - VII. Regulatory Impact and Regulatory Flexibility Analysis|
VII. Regulatory Impact and Regulatory Flexibility Analysis
The Occupational Safety and Health Administration (OSHA) has prepared a Regulatory Impact and Regulatory Flexibility Analysis for the Bloodborne Pathogens standard. The analysis is presented in seven sections: Introduction; Industry Profile; Benefits; Technological Feasibility; Costs of Compliance; Economic Impacts and Regulatory Flexibility Analysis; and Nonregulatory Environment and Regulatory Alternatives. Also, a technical appendix has been included, in which details of the two OSHA surveys and compliance rate computations are presented. Industry Profile Industries where workers are in contact with or handle blood and other potentially infectious materials will be affected by the standard. Twenty-four such industry sectors were identified for this analysis: offices of physicians (including ambulatory medical services) (SIC 801, 803); dental offices (SIC 802); hospitals (SIC 806); medical and dental laboratories (SIC 807); nursing homes (SIC 805); residential care facilities (SIC 836); dialysis centers (8092); drug treatment centers (8093); home health care (8082); hospices (various SIC codes); government outpatient facilities (SIC 9431); blood collections and processing (SIC 8099); health clinics in industrial facilities (various SIC codes); personnel services (SIC 7363); funeral homes and crematories (SIC 7261); research laboratories (SIC 8221; 8731; 8733; 283); linen services (SIC 721); medical and dental equipment repair (SIC 384; 7699) law enforcement (SIC 9221); fire and rescue (SIC 9224); correctional institutions (SIC 9223); schools for the mentally retarded (SIC 9411); lifesaving (9229); and handlers of regulated waste (SIC 4953; 9511).
Table E.S.-1 provides a summary of the number of affected establishments and employees by SIC classification. Over 500,000 establishments are estimated to be affected by the rule. Any employee who may come in contact with human blood and other potentially infectious materials and who comes under OSHA's purview is affected by this standard. On this basis, it is estimated that approximately 5.6 million workers will be affected by the standard. Approximately 78 percent of these workers are employed in health care occupations.
OSHA has estimated that occupational exposures are responsible for between 5,814 and 6,645 cases of hepatitis B virus (HBV) infection per year. In total, considering the full combination of the standard's provisions, including vaccination, engineering controls, work practices, protective clothing, housekeeping, and training, OSHA believes that the great majority of these HBV cases can be avoided.
TABLE E.S.-1 - INDUSTRY PROFILE OF AFFECTED ESTABLISHMENTS AND POPULATION AT RISK  ____________________________________________________________________ Number of SIC Code Type of Establishment Affected Population Establishments at Risk ____________________________________________________________________ 801;803 Offices of Physicians 122,104 640,681 802 Offices of Dentists 100,174 316,237 805 Nursing Homes 12,200 485,303 806 Hospitals 6,197 2,386,165 807 Medical and Denatl Labs 4,425 62,854 808 Home Health 6,437 212,246 * Hospices 651 10,856 8092 Hemodialysis 782 12,688 8093 Drug Rehabilitation 744 6,722 9431 Government Clinics 10,893 56,345 8099 Blood/Plasma/Tissue Centers 730 18,788 836 Residential Care 2,425 49,102 7362 Personal Services 1,348 163,477 726 Funeral Services 19,890 57,013 * Health Units in Industry 202,540 178,732 8221; 873; 283 Research Labs 1,453 89,151 7218 Linen Services 1,250 50,000 384 Medical Equipment Repair 1,076 6,185 9221 Law Enforcement** 4,946 341,546 9224 Fire and Rescue*** 3,174 252,048 9223 Correctional Facilities 1,895 120,244 9229 Lifesaving 100 5,000 9411 Schools 6,321 41,362 4953; 9511 Waste Removal -- 13,300 _____________________________________________________________________ TOTALS 511,755 5,576,026 * Includes various SIC Codes. ** Includes State and Local Departments only. *** Includes Fire Departments and Private Ambulance Services _______________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
In sum, compliance with the standard is estimated to prevent between 8,383 and 8,858 occupational and non-occupational cases of HBV infection per year, of which 2,096 to 2,215 would have resulted in acute symptoms, and 187 to 197 in death. Moreover, OSHA estimates that the standard will prevent between 253 and 578 employees from becoming HBV carriers, thereby halting the spread of this disease to others.
In addition to hepatitis B, the provisions of the standard will greatly reduce workers' risk of contracting non-A, non-B hepatitis, acquired immune deficiency syndrome (AIDS), and other bloodborne diseases. The Centers for Disease Control (CDC) reports 24 documented cases of human immunodeficiency virus (HIV) infection in the U.S. which have resulted from occupational exposure. Four of these workers have developed AIDS.
Limiting worker exposure to bloodborne diseases is achieved through the implementation of the following categories of controls:
* Engineering Controls * Immunization Programs * Work practices, such as careful hand-washing after each patient contact and procedures for handling sharps * Disposal and handling of contaminated waste * Use of personal protective equipment, especially gloves, gowns and goggles * Use of mouth pieces, resuscitation bags or other ventilation devices * Use of disinfectants * Labeling and signs * Training and education programs * Post-exposure follow-up
OSHA finds with respect to the technological feasibility of the standard that its provisions permit practical means to reduce the risk now faced by those employees working with blood and other infectious materials and that there do not appear to be any major obstacles to implementing the rule.
These conclusions were supported by OSHA's findings with respect to the current infection control practices in the workplace. Since the requirements of the standard closely follow the guidelines issued by the Centers for Disease Control (CDC) on universal precautions (UP), efforts by many organizations to adhere to the guidelines have created a solid base of practices and technology for the supplemental implementation of the standard. Based on recent surveys conducted by the Agency and other information available in the rulemaking docket, OSHA produced quantitative estimates of the compliance baseline, or extent of current compliance. OSHA found that most establishments have already implemented measures to protect workers from occupational exposure to blood and other potentially infectious materials, and that many are very close to full compliance with this standard.
Costs of Compliance
Net compliance costs were estimated for each provision of the standard by each type of facility affected. These costs represent the additional costs of fully complying with the requirements of the standard, after deducting from total cost the current baseline activities that already voluntarily occur at affected facilities. One-time costs were annualized to reflect the opportunity cost of capital. Table E.S.-2 summarizes annual net compliance costs by type of facility and by provision. The total annual costs amount to about $813 million.
Personal protective equipment accounts for the largest amount of net compliance costs ($327 million per year). Training ($134 million), vaccine and post-exposure follow-up ($107 million), and housekeeping ($102 million) were also found to be significant cost components.
OSHA found that costs varied among the various affected sectors, depending on the characteristics of exposure and extent of current compliance. Owing to these factors, certain establishments may find the impact of the standard to be somewhat greater than others.
TABLE E.S.-2 - SUMMARY OF COMPLIANCE COSTS - GRAND TOTALS
(For Table E.S.-2, Click Here)
Economic Feasibility and Regulatory Flexibility Analysis
Table E.S.-3 - SUMMARY OF ECONOMIC IMPACTS, provides a summary of economic impacts for the types of facilities affected by the standard. _____________________________________________________________________ Revenue, Annual Costs/ Costs/ Industry Budget(a) Profits(a) Costs Revenue Profits(g) ($ million) ($ million) ($ million) (%) (%) _____________________________________________________________________ Offices of 90,000 5,533(b) 143.99 0.160 2.602 Physicians Offices of Dentists 31,678 2,014(b) 87.43 0.276 3.590 Nursing Homes 45,872 1,159 69.78 0.152 4.577 Hospitals 230,000 1,012 321,91 0.140 6.998 Medical/ Dental Labs 4,446 325 12.32 0.277 3.797 Home Health Care(d) 8,900 503 11.45 0.119 2.106 Hospice Care 325.5 19 0.59 0.182 3.100 Hemodialysis Centers 1,200 87 2.31 0.192 2.637 Drug Rehibili- tation 744 45 0.41 0.056 0.926 Government Clinics(c) 2,400 N/A 10.66 0.444 N/A Blood/ Plasma/ Tissue Centers 1,500 N/A 4.01 0.267 N/A Residential Care 3,168 75(d) 4.36 0.138 4.674 Personnal Services 5,400 210 13.35 0.247 6.342 Funeral Services 6,762 608 8.84 0.130 1.454 Health Units in Industry (e) (e) 67.90 N/A N/A Research Labs 3,500 54(f) 6.32 0.181 3.991 Linen Services 4,800 99 1.94 0.040 1.962 Medical Equipment Repair 1,000 72 6.01 0.601 8.383 Police(c) 17,300 N/A 10.85 0.063 N/A Fire & Rescue(c) 4,000 N/A 15.01 0.375 N/A Corrections(c) 8,500 N/A 4.92 0.058 N/A Lifesaving(c) 140 N/A 0.47 0.338 N/A Schools(c) 2,774 N/A 5.97 0.215 N/A Waste Removal 595 22 1.87 0.314 4.245 N/A Not applicable (a) Revenue totals represent affected facilities only; profit totals reflect estimated pre-tax 1989 totals for proprietary establishments, unless noted otherwise. (b) Revenue data represent non-public agencies only. (c) Revenue data represent public agencies only. (d) Based on profit margin of nursing home sector. (e) Health care budgets not estimated. (f) Represents commercial, noncommercial, and pharmaceutical Labs. (g) Ratio reflects proprietary firm, unless noted otherwise. ____________________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
As shown, OSHA estimated compliance costs to represent less than 1 percent of revenues for all sectors, and less than one-half of 1 percent for most others.
The cost of the standard relative to profit was estimated to be largest for the medical equipment repair sector, where costs may represent over 8 percent of profits. OSHA estimated profit impacts to be less than 7 percent for all other sectors.
These estimates and the inelastic demand for health care services led the Agency to conclude that it is probable a large part of the compliance costs for establishments in SIC 80 (health care) will be passed on to consumers and third party payers. In addition, OSHA estimated most affected establishments will be able to finance the balance of compliance costs from profits. OSHA concludes that impacts will not impose a significant burden on industry. Impacts were not estimated to exert significant pressure toward increased industry concentration.
OSHA also found that a large number of small businesses will be affected by the rule. In general, OSHA did not find that smaller establishments lagged appreciably behind their larger counterparts with respect to current practices. This indicates that the differential impact related to the implementation of similar, supplemental employee protection measures as required under the standard, will be minimal between small and large firms. Thus, the impact on small business should not differ significantly from the impact on the affected universe as a whole.
Executive Order 12291 (46 FR 13197, February 19, 1981) requires that a regulatory impact analysis be conducted for any rule having major economic consequences on the national economy, individual industries, geographical regions, or levels of government. Similarly, the Regulatory Flexibility Act (5 U.S.C. Subsection 601 et seq.) requires the Occupational Safety and Health Administration (OSHA) to consider the impact of the regulation on small entities.
Consistent with these requirements, OSHA has prepared a Regulatory Impact and Regulatory Flexibility Analysis for the Bloodborne Pathogens standard. This analysis describes the industries affected by the standard, the potential benefits that will be realized by health care and other workers currently at risk, the current infection control practices in the workplace, the costs of compliance, and OSHA's assessment of the technological and economic feasibility of the standard.
B. Industry Profile
1. Profile Overview
Of interest in this rulemaking are those workplaces in which employees are exposed to blood or other potentially infectious materials during the performance of their duties. OSHA has included twenty-four such industry sectors in this analysis: offices of physicians (including ambulatory medical services) (SIC 801, 803); dental offices (SIC 802); hospitals (SIC 806); medical and dental laboratories (SIC 807); nursing homes (SIC 805); residential care facilities (SIC 836); dialysis centers (8092); drug treatment centers (8093); home health care (8082); hospices (various SIC codes); government outpatient facilities (SIC 9431); blood collections and processing (SIC 8099); health clinics in industrial facilities (various SIC codes); personnel services (SIC 7363); funeral homes and crematories (SIC 7261); research laboratories (SIC 8221; 8731; 8733; 283); linen services (SIC 721); medical and dental equipment repair (SIC 382; 384; 7699) law enforcement (SIC 9221); fire and rescue (SIC 9224); correctional institutions (SIC 9223); schools (SIC 9411); lifesaving (9229); and regulated waste removal (SIC 4953).
Four sectors, linen services, schools, lifesaving, and regulated waste removal, were not included in OSHA's Preliminary Regulatory Impact Analysis (PRIA) [54 FR 23073]. New information received during the post-proposal comment period and during OSHA's informal hearings indicated, however, that occupational exposure to blood and other potentially infectious materials also occurred in these service sectors.
OSHA's final estimates of the number of affected establishments were based on information obtained from various sources, including government statistical publications, public comments and testimony, and two surveys conducted by the Agency. A multi-sector survey conducted during 1989 encompassed eighteen industry sectors. A separate survey of hospitals was also conducted. Health care and non-health care workers employed by state and local governments in non-state-plan states and self-employed facilities were not included in the scope of the survey. The objectives of the surveys were to estimate the number of potentially exposed workers, the extent of current compliance, the number of employee blood exposure incidents occurring in the workplace, and the number of affected establishments. Only facilities with exposure to blood or other potentially infectious materials were considered to be affected by the standard.
Each question in the each survey was carefully reviewed, and interviewers were highly trained to ensure the accuracy of data collected. Pre-notification letters were sent to all establishments in the sample to prepare respondents for the telephone interview. The interviewers collected data using a Computer Assisted Telephone Interviewing (CATI) system, which allowed the computer to immediately identify answers that were out of range or inconsistent with previous answers. In these cases, the interviewers resolved the problems by asking the respondent for clarification. This method virtually eliminated the problem of invalid and inconsistent responses arising during the data collection process.
Although only 2,545 responses were required to achieve statistical accuracy, OSHA received over 3,500 responses. For further details on the survey, see Appendix A and Appendix B. References made to OSHA survey data will refer to either Ex. 264 (multi-sector survey) or Ex. 266 (hospital survey) and will list the relevant table number(s) where the estimates appear, or from which OSHA derived figures used in its calculations. (See Technological Feasibility below and Technical Appendices A and B for details on survey methodology and results.) For example, calculations incorporating the estimated number of health care workers exposed to blood or other potentially infectious materials would be referenced as [Ex. 264, Q38] for non-hospital sectors, with tabulated data from question 38 noted.
Table VII-1 enumerates affected establishments and occupationally exposed workers by SIC code. As shown in the table, an estimated 511,755 establishments will be affected by the standard.
TABLE VII-1 - INDUSTRY PROFILE OF AFFECTED ESTABLISHMENTS AND POPULATION AT RISK  _____________________________________________________________________ Number of Population SIC Code Type of Establishment Affected at Risk Estab. _____________________________________________________________________ 801;803 Offices of Physicians 122,104 640,681 802 Offices of Dentists 100,174 316,237 805 Nursing Homes 12,200 485,303 806 Hospitals 6,197 2,386,165 807 Medical and Denatl Labs 4,425 62,854 808 Home Health 6,437 212,246 * Hospices 651 10,856 8092 Hemodialysis 782 12,688 8093 Drug Rehabilitation 744 6,722 9431 Government Clinics 10,893 56,345 8099 Blood/Plasma/Tissue Centers 730 18,788 836 Residential Care 2,425 49,102 7362 Personal Services 1,348 163,477 726 Funeral Services 19,890 57,013 * Health Units in Industry 202,540 178,732 8221; 873; 283 Research Labs 1,453 89,151 721 Linen Services 1,250 50,000 38;7699 Medical Equipment Repair 1,076 6,185 9221 Law Enforcement** 4,946 341,546 9224 Fire and Rescue*** 3,174 252,048 9223 Correctional Facilities 1,895 120,224 9229 Lifesaving 100 5,000 9411 Schools 6,321 41,362 4953; 9511 Waste Removal -- 13,300 _____________________________________________________________________ TOTALS 511,755 5,576,026 * Includes various SIC Codes. ** Includes State and Local Departments only. *** Includes Fire Departments and Private Ambulance Services _______________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
OSHA's final estimates of the affected worker population were also based on the OSHA surveys, as well as various other sources (see General Overview of Methodology and individual sector profiles below). Table VII-2 provides a tabular summary of the populations at risk, by occupational category. (Unless noted otherwise, estimates of the population at risk and the number of affected establishments include state and local government representation only for states with occupational safety and health plans in place. A total of about 1.2 million workers employed by state and local governments in non-state-plan states were estimated to be at risk, but are not covered by the rule. Moreover, these data do not include an estimated 190,000 self-employed physicians and dentists who do not fall under OSHA's purview.)
TABLE VII-2 - OCCUPATIONAL EMPLOYMENT DISTRIBUTION OF THE POPULATION AT RISK (1990) _____________________________________________________________________ NUMBER OF AFFECTED WORKERS ============================================================= | | | Physi-|Med./| |Resid | | | |Dental | cians |Dent.|Nursing|ential|Home |Hospice OCCUPA- |Hospitals|Offices|Offices|Labs |Homes |Care |Health|Care TION | | | | | | | | ________|_________|_______|_______|_____|_______|______|______|______ Healtcare Workers 1,960,639 313,219 593,992 450,567 41,211 202,946 10,665 Morticians Paramedics Emergency Personnel Laboratory 164,604 57,421 Workers Educators Corrections Officers Firefighters Line of Duty Officers Unpackers Equipment Cleaners Equipment Cleaners Equipment Technicians Housekeepers/ Janitorial 157,520 3,018 4,283 445 27,221 1,138 3,000 164 Drivers/ Couriers 4,988 Service Personnel 103,402 7,515 Additional Workers 42,406 6,753 6,300 27 ________________________________________________________________________ TOTAL 316,237 62,854 49,102 10,856 AT-RISK 2,386,165 640,681 485,303 212,246
The most common routes of exposure are by needlestick or entry through mucosal membranes or non-intact skin. These types of exposure occur across all of the affected industry sectors and throughout the various occupational categories. Exposure also takes place via cuts with sharp instruments or broken glass. Other routes of exposure are more or less confined to certain types of procedures. For example, laboratory employees may be exposed to contaminated equipment such as centrifuges or pipetting devices.
The remainder of this section is presented in the form of a general overview describing OSHA's reasoning and estimation methodology with respect to its estimates of the number of affected facilities and population at risk, followed by an examination of each industry.
2. General Overview of Methodology
In developing the estimates of the number of affected facilities and the population at risk, OSHA relied heavily on the data produced by its 1989 nationwide statistical sample surveys of health care and other service sector establishments. In some sectors, OSHA surveyed only a portion of the overall universe; in such cases, additional data from the record were used to supplement survey generated statistics.
Secondary sources relied upon included: # U.S. Department of Labor: - Bureau of Labor Statistics - Industry Occupation Matrix, 1988 (IOM) - Bureau of Labor Statistics - Employment and Earnings, September, 1990 (E&E) # U.S. Department of Commerce: - Bureau of the Census - County Business Patterns, 1987 (CBP) - Bureau of the Census - Census of Service Industries, 1987 (CSI) # U.S. Department of Justice: - Bureau of Justice Statistics - Census of Local Jails, 1988 (CLJ) - Bureau of Justice Statistics - Profile of State and Local Law Enforcement Agencies, 1987 (PLEA) - Bureau of Justice Statistics - Sourcebook of Criminal Justice Statistics, 1988 (SCJS)
The statistical survey conducted by the Agency provided a sound framework for developing estimates of the costs and economic impacts of the bloodborne pathogens rule. (In addition to estimates of the affected universe and the population at risk, estimates of the extent of current compliance with the provisions of the standard were generated via the statistical sample survey. These estimates are discussed in the Technological Feasibility section of this preamble, and in Technical Appendix B.) To facilitate the incorporation of survey data into the analysis, and to enable the development of more accurate estimation models, survey data were collected and tabulated with respect to four major occupational groups. OSHA labeled these groups simply A, B, C, and D. The major occupational groups represented in Category A are workers directly involved in providing health care; laboratory workers, emergency responders and firefighters in Category B; housekeepers and janitorial workers in Category C; and additional workers in Category D. Table VII-3 presents survey data showing occupations cross tabulated by industry sector.
TABLE VIII-3 - EMPLOYMENT CLASSIFICATION SCHEME _______________________________________________________________________ | | | Cate-| | | gory| Offices of Physicians | Offices of Dentists | Nursing Homes _____|_______________________|_____________________|___________________ | | | A |Health Care Workers |Health Care Workers |Health Care Workers | | | |(Physicians and |(Physicians and |(Physicians and |Surgeons; Registered |Surgeons; Dentists; |Surgeons; Dentists; |Nurses; Therapists; Lab|Registered Nurses; |Registered Nurses; |Technicians, Emergency |Therapists; Dental |Therapists; Dental |Medical Technicians; |Hygienists; Lab |Hygienists; Lab |Surgical Technicians; |Technicians; Surgical|Technicians; Other |Other Health |Technicians; Other |Health |Professionals; Licensed|Health Professionals;|Professionals; |Practical Nurses; |Licensed Practical |Licensed Practical |Therapy Assistans; |Nurse; Dental |Nurse; Dental |Other Health Service; |Assistans; Other |Assistants; Nursing |Physician Assistans; |Health Service; |Aids and Orderlies; |Medical Assistants; |Medical Assistants.) |Psychiatric Aides; |Nursing Aids.) | |Other Health | | |Service; Physician | | |Assistants; | | |Mecial Assistants.) | | | | | | |Affected Population: |Affected Population: |Affected Population: | 593,992 | 313,219 | 450,567 |Exposed to splash/ |Exposed to splash/ |Exposed to splash/ | splatter: 348,822 | splatter: 281,897 | splatter: 197,617 _____|_______________________|_____________________|___________________ | | | B | None | None | None | | | | | | _____|_______________________|_____________________|___________________ | | | C |Housekeepers/Janitorial|Housekeepers/ |Housekeepers/ | | Janitorial | Janitorial | | | |Affected Population: |Affected Population: |Affected Population: | 4,283 | 3,018 | 27,221 |Exposed to splash/ |Exposed to splash/ |Exposed to splash/ | splatter: 0 | splatter: 425 | splatter: 6,645 | | | _____|_______________________|_____________________|___________________ | | | D |Additional Workers |Additional Workers |Additional Workers | (Health Aides) | (None) | (Service) | | | |Affected Population: | |Affected Population: | 42,406 | | 7,515 |Exposed to splash/ | |Exposed to splash/ | splatter: 0 | | splatter: 1,958 | | | _____|_______________________|_____________________|___________________
Based on its survey, OSHA estimated 163,000 establishments in the physicians' offices sector. Many physicians operate multiple satellite offices which they may visit and staff only when office hours are held at that location. To count these offices as establishments would have overstated the count. OSHA believes that its final survey count of 163,000 establishments represents the best estimate of the number of practices in this sector; out of business, out of scope, and temporary offices were excluded from the total. (Also included in this estimate of establishments are ambulatory care centers and health maintenance organizations (HMO), since these centers are now included under SIC 801.) To estimate the number of affected establishments, OSHA relied on answers to questions in the multi-sector survey which indicated that occupational exposure to blood and other potentially infectious materials occurred in about 75 percent of the estimated 163,000 physicians' offices [Ex. 264, Q11]. Thus, about 122,104 establishments were estimated to be affected by the standard. Although 75 percent seems rather low, this percentage reflects a developing trend for physicians' offices to contract blood and serum work out to medical laboratories. Furthermore, psychiatry and some opthalmology practices did not have routine blood exposure. The number of occupationally exposed workers was estimated directly from survey-generated statistics, which were tabulated separately for each of the four occupational categories introduced above. Thus, for category "A" workers, OSHA estimated the occupationally exposed worker population to be 593,992, as presented in Table 38 of OSHA's multi-sector survey [Ex. 264]. Tables 46 and 50 provided estimates of the number of occupationally exposed category "C" and "D" workers, respectively (no category "B" workers were employed in physicians' offices). Thus, in total, OSHA estimated 640,681 workers to be occupationally exposed in this sector.
OSHA developed the industry profiles for the balance of the affected sectors following the methodology outlined above for physicians' offices. In sectors where additional data were deemed necessary to supplement survey data, alternative methods and reasoning are presented.
Estimates of financial indicators (revenue/receipt, profit levels) are also presented in the Sector Profiles. In general, OSHA estimated pre-tax profits based on Dun and Bradstreet financial reports (Industry Norms and Key Business Ratios, 1990) and corporate tax schedules.
3. Sector Profiles Offices of Physicians
Frequency and type of exposure in a physician's office depends on the type of practice and the distribution of tasks. It is likely that phlebotomy is performed in a large number of offices, especially those with laboratory facilities. Injections are also commonly administered. Physicians performing gynecological examinations or examining patients for sexually transmitted diseases are most certainly at risk. Routine physical exams can also put the examining physician at risk. Other types of procedures commonly encountered which place physicians and physicians' assistants at risk are treatment of lacerations, abrasions, and compound fractures.
While some physicians' offices have contracted out blood analysis work, others have established office laboratories (POLs). These office-based laboratory facilities have recently grown in number by about 15 percent annually, though the total number of such facilities is unknown [Ex. 13, p. I-38].
Another possible activity which could involve occupational exposure to blood in the physicians' office is housekeeping. However, it does not appear that, in general, housekeepers perform tasks involving exposure in physicians' offices, as only about 3 percent of offices reporting blood exposure on the OSHA survey indicated that housekeepers were occupationally exposed [Ex. 264, Qs. 45, 11].
OSHA estimated the number of affected establishments in this sector to be 122,104 [Ex. 264, Q11], while the population at risk was estimated to be 640,681 [Ex. 264, Qs. 38, 46, 50]. These estimates were generated from data collected as part of OSHA's multi-sector survey.
Commerce Department estimates indicate a level of $120 billion dollars in expenditures for physicians' services in 1989 [1990 U.S. Industrial Outlook, U.S. Department of Commerce, p. 49-1]. Considering only establishments affected by the standard, total revenue was estimated to be $90 billion, while profits were estimated to be $5.5 billion.
Offices of Dentists
A common route of exposure in the dental office is allowing chapped or abraded skin to come into contact with saliva and/or blood. Needle punctures are a potential hazard and instances where the face or eyes are splashed or spattered with saliva, blood, or tissue fluids represent risk. Dental workers are also exposed if improper procedures are employed when disinfecting dental instruments. Frequency of exposure varies by specialty, with oral surgery presenting a greater potential for exposure and orthodontics presenting a lesser potential for exposure. Housekeepers may also be exposed, though this does not often appear to be the case [Ex. 264, Qs. 45, 46].
OSHA estimated that 100,174 dental facilities will be affected by the rule [Ex. 264, Q11]. (This includes only those offices where salaried employees are exposed to blood.) This estimate is based on the results of the multi-sector survey, and was found to be consistent with other sources. The occupationally exposed workforce was estimated to be 316,237 employees. This estimate was derived by adjusting OSHA survey results [Ex. 264, Qs. 38, 46] to account for non-incorporated owner (self employed) dentists.
Data on expenditures for dental care were submitted by the American Dental Association (ADA) [Ex. 20-665, p. 7]. Expenditures for dental care in 1987 were reported to be $32.8 billion. Commerce Department estimates indicated 1989 expenditures would reach $33.7 billion [1990 U.S. Industrial Outlook, U.S. Department of Commerce].
Receipts for affected establishments in 1989 were estimated to be $31.7 billion. By applying the pre-tax profit rate for the dental sector to the revenues of proprietary firms, pre-tax profits for 1989 were estimated to be $2 billion.
Most hospitals perform a great variety of services, and there are many different exposure scenarios. One frequently reported was needlestick, with the greatest potential for exposure occurring during needle recapping [Ex. 13, pp. II-16, II-19]. Other hospital procedures that are associated with frequent exposure include phlebotomy, IV line placement, bronchoscopy, intubation, airway suction, endoscopy, colonoscopy, and proctosigmoidoscopy [Ex. 13, p. II-19]. Areas with the greatest potential for exposure include the emergency room, surgical suite, hemodialysis center, and intensive care unit. Laundry workers and janitors may also be exposed, particularly when handling soiled linen or refuse.
It is estimated that 6,197 hospitals will be affected by the standard [Ex. 266]. This estimate is based on the 1989 OSHA survey of hospitals. (Hospitals in states without state occupational safety and health plans were excluded.) OSHA estimated that 2,386,165 workers are at risk in hospitals [Ex.
266, Qs. 7-12]. Based on responses given during the hospital survey, approximately 86 percent of all direct patient care employees, 88 percent of all laboratory employees, and 47 percent of all service employees were estimated to be occupationally exposed. Nurses and nursing aides comprise over 60 percent of the population at risk.
Expenditures on hospital care were estimated to be $230 billion in 1989 [1990 U.S. Industrial Outlook, U.S. Department of Commerce].
The total margin for hospitals (the difference between revenue from all sources and total expenses expressed as a percentage of total revenue) was preliminarily estimated to be about 4.5 to 5 percent [Ex. 13, p. I-10]. However, rural hospitals indicated margins ranging from negative to about 2 percent [Exs. 20-713; 20-891; 20-946]. These hospitals did not specify whether these data represented total margin or patient margin (the percentage of patient revenue retained after expenses). The Connecticut Hospital Association reported statewide average total margin to be 2.2 percent [Ex. 20-275].
Medical and Dental Laboratories
Procedures that most often result in exposure in the laboratory are specimen collection and specimen processing. Workers are exposed through needlesticks (phlebotomists), spills, or the improper use of laboratory equipment, such as the centrifuge. Phlebotomists appear to have the highest rate of exposure incidents [Ex. 13, p. II-68].
OSHA estimated the number of affected establishments in this sector to be 4,425 [Ex. 264, Q11], while the population at risk was estimated to be 62,854 [Ex. 264, Qs. 38, 46, 50]. These estimates were generated from data collected as part of OSHA's multi-sector survey.
Based on Department of Commerce data, revenue for medical and dental labs was estimated to be $5.2 billion and $1.9 billion, respectively, in 1988 [Ex. 13, p. I-39]. Pre-tax profits were estimated at $348 million and $127 million for the two subsectors for that year [Ex. 13, p. I-39]. Commerce Department data also indicated an increase in expenditures, however, of 10 percent for health services and supplies between 1988 and 1989 [1990 U.S. Industrial Outlook, U.S. Department of Commerce, p. 49-1]; thus, OSHA estimated 1989 revenue for medical and dental labs to be $5.7 billion and $2.1 billion, respectively. Associated pre-tax profits were estimated to total $570 million for the two subsectors for 1989, respectively.
Considering only establishments affected by the standard, total revenue was estimated to be $4.4 billion, while profits were estimated to be $325 million.
Sandra Fitzler, corporate safety director and an occupational health nurse for the nation's second largest nursing home chain, testified at OSHA's informal hearing in Washington, D.C. that the majority of nursing home residents require assistance in performing routine activities, such as bathing, dressing, grooming, toileting, mobility, and eating [Tr. 9/21/89, p. 44]. These tasks are not associated with excessive exposure to potentially infectious materials. According to Ms. Fitzler, who represented the American Health Care Association (AHCA), "very few injections and almost no intravenous infusions are administered" [Tr. 9/21/89, p. 44].
Situations where exposure would be expected were described by the Service Employees' International Union (SEIU) in their post-hearing brief:
It is SEIU's experience that nursing home workers come in contact daily with blood and body fluids. Nursing home workers frequently are exposed to drainage from decubitus ulcers, and to blood contaminated urine and feces from incontinent patients. [Ex. 299, p. 35]
It is the nursing aide who most often comes into contact with body fluids of patients [Tr. 10/18/89, p. 387].
OSHA's field survey identified almost 13,000 establishments in this sector. The number of affected establishments was estimated to be 12,200 [Ex. 264, Q11]. The number of occupationally exposed workers in this sector was estimated to be 485,303 [Ex. 264, Qs. 38, 46, 50].
Based on Commerce Department data, gross revenues for all nursing homes were about $43.9 billion in 1988, increasing to $48.8 billion in 1989 [1990 U.S. Industrial Outlook, Department of Commerce, p. 49-1].
Considering only establishments affected by the standard, total revenue was estimated to be $45.9 billion, while profits were estimated to be $1.6 billion in 1989.
Nursing aides and orderlies make up the largest percentage of workers involved in residential care followed by nurses. Blood exposures in residential care occur less often than in nursing homes. According to Vera Rublinger of AHCA, residential care patients are generally more independent and have less need for staff to assist with bodily functions, etc. [Tr. 9/21/89, p. 68]. The number of residential care providers affected by the standard is 2,425 [Ex. 264, Q11], while the number of occupationally exposed workers in this sector is estimated to be 49,102 [Ex. 264, Qs. 38, 46, 50].
Revenues for 1988 were estimated to be $8.7 billion [Ex. 13, p. I-66]. Allowing for a 10 percent increase in expenditures between 1988 and 1989 [1990 U.S. Industrial Outlook, U.S. Department of Commerce, p. 49-1], 1989 revenues were estimated to be $9.6 billion.
Considering only establishments affected by the standard, total revenue was estimated to be $3.2 billion, while pre-tax profits were estimated to be $75 million (the pre-tax profit margin for nursing homes was applied to the residential care sector).
Though critically ill clients of hospice services often do not require the intensive care received by hospital patients; occupational exposure to blood or other potentially infectious materials may occur in hospices, although exposure generally would not involve large quantities of fluids or other material. OSHA's best estimate of the number of hospices is 944 [Ex. 264, Q3]. To estimate the prevalence of blood exposure in hospices, OSHA relied on its survey. Respondents reported no occupational exposure in 31 percent of hospices surveyed; thus, OSHA estimated the number of hospices affected by the standard to be 651 [Ex. 264, Q11], with 10,856 employees occupationally exposed [Ex. 264, Qs. 38, 46, 50].
Total annual revenue for affected establishments in this sector was estimated to be $325.5 million in 1989. Pre-tax profits were estimated to be $19 million.
Home Health Care
Circumstances of exposure to blood or other potentially infectious materials in home health care are similar to those of nursing homes or residential care, and may range from situations with a very low potential for exposure to activities providing regular exposure. Clients may require non-medical services, such as those provided by Kelly Assisted Living: "although a company may indeed provide home health services, this does not necessarily mean that the company provides the types of services that expose its employees to blood or other body fluids." [Ex. 20-1298]. However, services may also be provided which require the use of sharps; SEIU noted that in some locations "over one in twenty homecare workers regularly give their clients injections" [Ex. 299, p. 38].
The number of home health care facilities was estimated to be 7,573, based on 1987 data on Medicare-certified establishments and on 1987 data from the National Association of Home Health Care [Ex. 13, p. I-73]. (This estimate excludes 50 percent of all government administered agencies, OSHA's estimate of agencies operating in non-state plan states.) To estimate the number of agencies affected by the standard, OSHA applied the exposure prevalence factor obtained through its survey. Respondents indicated that employees were occupationally exposed in 85 percent of home health agencies surveyed [Ex. 264, Q11]; the number of agencies affected by the standard was estimated to be 6,437, with 487 believed to be government administered.
To develop its estimate of the exposed workforce, OSHA relied on comments received from the public, as well as the multi-sector survey. For example, the Home Care Association of New York State reported that an estimated 70,860 home health workers in 652 entities in the state are potentially affected by the regulation [Ex. 20-929]. Similar information was received from SEIU, who reported in their post-hearing brief that 50,000 home health aides are employed in Los Angeles County alone, and that more than 600,000 home health workers could be at risk nationally [Ex. 299, p. 52].
OSHA's survey of private home health agencies indicated an average of 51 health care workers per agency [Ex. 264, Q22]. Thus, all affected non-government agencies employed 303,450 health care workers (5,950 x 51). As noted above, some government administered agencies appear to employ greater numbers of care givers. If the national average is similar to that of New York State at 108 workers per agency (70,860/652), the estimated number of care givers for government entities in state plan states was estimated to be 52,596. Thus, 356,046 health care providers are estimated to be employed in home health agencies affected by the standard.
To estimate the number of occupationally exposed health care workers, OSHA used factors derived from data obtained from its multi-sector survey. Using data from responses to questions 38 and 22, it was estimated that 57 percent of all health care workers employed by agencies where blood exposure was reported were actually occupationally exposed [Ex. 264, Qs. 22, 38](1). Thus, OSHA estimated that 202,946 health care workers are occupationally exposed in this sector.
__________ Footnote(1) To derive the estimated percentage of health care workers (category "A" workers) occupationally exposed, the number of occupationally exposed health care workers (obtained from participants' weighted responses to Q38), 41,191, was divided by the total number of health care workers employed (obtained from participants' weighted responses to Q22), 71,964.
OSHA also derived estimates of the number of exposed housekeepers in this sector. Based on multi-sector survey data, OSHA estimated 3 housekeepers to be occupationally exposed in approximately 15 percent of all affected agencies [Ex. 264, Qs. 45, 46]. Thus, OSHA estimated approximately 3,000 housekeepers to be exposed in this sector (6,437 x 0.15 x 3). Survey respondents also indicated "other" workers were exposed in approximately 14 percent of all affected facilities [Ex. 264, Q49]. OSHA estimated an average of 7 workers to be exposed in such facilities [Ex. 264, Q50]; thus, 6,300 additional workers were identified as being affected by the rule.
In sum, OSHA identified 212,246 workers affected by the rule in this sector.
Annual revenue for non-public agencies was estimated based on data obtained from the OSHA survey. Total revenue for affected establishments was estimated to be $8.9 billion in 1989 ($1.5 million x 5,950). Associated pre-tax profits were estimated to be $500 million.
The number of temporary help agencies affected by the standard is estimated to be 1,348. This includes an estimated 530 agencies which supply health care workers [Ex. 264, Q37] and an estimated 818 agencies which supply laborers or service workers, who may come into contact with blood or other potentially infectious materials in the form of regulated waste [Ex. 264, Q49].
The population at risk for this sector was estimated to be 163,477. This estimate includes 61,387 health care workers and 102,090 service workers.
Information supplied at the hearing in Washington, D.C. by the Home Health Services and Staffing Association (HHSSA) indicated a population of over 200,000 temporary nurses and aides were provided by personnel services [Tr. 9/21/89, p. 87]. However, no data were submitted regarding the prevalence of occupational exposure; thus, OSHA relied upon its multi-sector survey estimates in performing its calculations, as these were the best data available in the record.
While revenues for all personnel supply companies were reported to be $10.4 billion in 1986 [Ex. 13, p. I-88], OSHA estimated that average revenue was about $4.0 million (66 percent of affected facilities reported annual revenue in excess of $3.5 million on the multi-sector survey [Ex. 264, Q196]). Thus, annual revenue of personnel service companies affected by the rule was estimated to be $5.4 billion. Associated pre-tax profits were estimated by OSHA to be $210 million.
Drug Treatment Centers
Opportunities for occupational exposure in drug rehabilitation centers, though infrequent, would be expected to arise during use of sharps or through contact with open wounds.
The best source of data on which to base an estimate of the number of potentially affected drug treatment centers is the OSHA multi-sector survey. The estimate generated from the survey, 3,916 independent centers, is based on the 1987 National Drug and Alcoholism Treatment Unit Survey, from which OSHA drew its sample. (The survey excluded centers based in hospitals or correctional institutions.) Only 19 percent of these establishments reported that employees were occupationally exposed [Ex. 264, Q11]. Thus, OSHA estimated the number of establishments affected by the standard to be 744.
The number of affected employees was also based on the OSHA survey. Estimates from the responses to question 38, for health care workers (6,067), question 46, for housekeepers (149), and question 50, for "other" workers (506) were summed totalling 6,722 workers at risk.
To estimate annual revenues for this sector, OSHA relied on the financial profile of respondents to its multi-sector survey [Ex. 264, Q196]. Based on these data, OSHA estimated average revenue to be about $1 million in 1989. Total annual revenues for establishments affected by the standard were thus estimated to be $744 million for this sector. Associated pre-tax profits were estimated to be $45 million.
Principal occupational hazards to workers in hemodialysis centers include contaminated sharps and contaminated dialysis equipment.
Medicare-certified hemodialysis centers numbered 1,578 in 1986, but only 861 were freestanding (not affiliated with hospitals or other health care facilities) [Ex. 13, p. I-75]. Based on a 1987 listing obtained from the Health Care Financing Administration, OSHA surveyed the sector as part of its multi-sector survey; using these survey data, OSHA estimated 782 freestanding facilities [Ex. 264, Q3]. Based on responses to the OSHA survey, all of these facilities will be affected by the standard [Ex. 264, Q11].
The population at risk was also estimated from responses to the OSHA multi-sector survey. Approximately 12,000 health care workers were estimated to be occupationally exposed in hemodialysis centers [Ex. 264, Q38]. In addition, 209 housekeepers and 553 maintenance workers and equipment technicians were estimated to be exposed [Ex. 264, Qs. 46, 50]. In sum, 12,688 workers are occupationally exposed in hemodialysis centers.
To estimate the annual revenues of this sector, OSHA used the financial profile of respondents to its multi-sector survey. Based on this data, OSHA estimated average revenue to be about $1.5 million in 1989. Total annual revenues for establishments affected by the standard were estimated to be $1.2 billion for this sector. Associated pre-tax profits were estimated to be $87 million.
Government Outpatient Care Facilities
Public clinicians perform procedures typical of physicians' offices, and thus exposure risks are similar to those outlined for that sector.
Public clinics for general medical care were not surveyed. However, OSHA estimates that 10,893 government outpatient care facilities are in operation. This estimate assumes that each of 10,483 local administrations operate at least one public outpatient clinic in states with state occupational safety and health plans [Ex. 13, p. I-75]. OSHA also assumed that each of 82 metropolitan statistical areas (MSA) located in states with state occupational safety and health plans operate 5 public clinics, on average. OSHA estimated that all clinics would be affected by the standard.
The affected worker population was estimated to be 56,345. This estimate was derived by assuming that staffing levels and potential for occupational exposure in public clinics resemble staffing levels and potential for occupational exposure in physicians' offices and ambulatory clinics. For example, based on survey data collected from physicians' offices affected by the standard, OSHA estimated that average employment for health care, or category "A," workers was 5.7 employees per affected establishment [Ex. 264, Q22]. It was also estimated that 84 percent of these workers were occupationally exposed [Ex. 264, Qs. 22, 38](2). Applying these figures to the 10,893 affected public clinics yields an estimated 52,156 occupationally exposed health care workers in this sector. Summing estimates for occupationally exposed housekeepers and "other" workers identified in the OSHA survey, OSHA estimated that 56,345 workers were occupationally exposed in this sector.
__________ Footnote(2) These calculations were performed in a manner similar to that described for the home health sector. See Footnote (1).
Revenues were estimated to be 50 percent of private physicians' offices. Private physicians' offices average about $450,000 in revenue annually; OSHA estimated annual funding for government clinics to be $2.4 billion.
Blood Collections and Processing
Workers in this sector are exposed most often during blood collection and blood processing. As in medical and dental labs, workers in this sector are exposed through needlesticks (phlebotomists), mucous membrane contacts, spills, or the improper use of laboratory equipment, such as the centrifuge [Ex. 13, p. II-125].
Recent data (1989 Food and Drug Administration (FDA) listing of blood collection and processing facilities) indicate 293 blood centers (excluding blood centers in hospitals and military facilities) and 425 plasma centers. Accepting these data, OSHA estimates that 718 blood and plasma centers will be affected by the standard. Additionally, 12 tissue banks were estimated to be affected [Ex. 13, p. I-95].
OSHA's best estimate of the population at risk for all establishments in this sector was estimated to be 18,788 workers [Ex. 264, Qs. 38, 46, 50]. This total included 18,198 health care workers (phlebotomists, nurses, and laboratory workers), 200 housekeepers, and 390 "other" workers at risk (including maintenance workers, drivers, and technicians).
Revenue for blood centers was estimated at $1.3 billion in 1987, based on data obtained from 106 members of the American Association of Blood Banks (AABB) [Ex. 13, p. I-96]. More recent information indicated a unit of blood represented about $50 in revenue, on average [Ex. 6-627]. Since blood banks draw an estimated 12 million units annually [Trs. 9/21/89, p. 11; 10/20/89, p. 758], annual revenue of at lease $600 million was indicated. Since there is a great deal of uncertainty on revenue for this sector, OSHA estimated total revenue for this SIC to be the average of these data (approximately $1 billion). No data were available which would allow OSHA to estimate profit/operating margins for these establishments.
Health Care Personnel in Industrial Facilities
Traumatic injuries occur in industrial facilities, giving rise to the potential for blood exposure. Invasive procedures or the administration of injections may also occur.
This group of establishments includes industrial facilities with health care or designated emergency response personnel. These facilities are found throughout manufacturing sectors and are not unique to any SIC code or industry.
OSHA's best estimate of the universe is 203,622, based on NIOSH's 1981-1982 National Occupational Exposure Survey [Ex. 13, p. I-101]. This total includes 36,056 plants with health units and 185,594 plants with emergency health care personnel [Ex. 13, p. I-101]. Since responses to the OSHA survey of large industrial facilities (establishments with a total workforce of 500 employees or more) indicated that approximately one-half of the plants with health units also employed emergency personnel, OSHA estimates that about 18,028 plants employ both types of health care workers.
Estimates generated from OSHA's multi-sector survey indicated that workers were occupationally exposed to blood or other potentially infectious materials in 97 percent of all health units surveyed [Ex. 264, Q11]. Thus, 34,974 health units were estimated to be affected by the standard (36,056 x 0.97). OSHA assumed that all establishments where designated emergency personnel are employed will be affected. Therefore, the estimate of the affected universe includes 16,946 plants with health units only, 18,028 plants employing health unit workers and emergency personnel, and 167,566 plants employing emergency personnel only (185,594-18,028 health units employing emergency personnel). Thus, OSHA's best estimate of the affected universe of establishments is 202,540.
An estimate of the number of emergency personnel and health care workers employed in health units was derived from the NIOSH survey [Ex. 13, p. I-101]. It was assumed that 185,594 facilities employing emergency response personnel, employed one such worker. In the survey of health care workers in health units, a physician and one additional employee, on average, were reported in 2,251 units. Assuming that 97 percent of these have potential exposures to blood or other potentially infectious materials, 2,183 units have potentially exposed workers. In 32,791 (34,974-2,183) health units, one health care worker was employed [Ex. 13, p. I- 101]. Thus, OSHA estimated 37,157 health care workers were employed in health units.
Based on the survey, OSHA estimated that 76 percent, or 141,051 (185,594 x 0.76), of all emergency personnel were occupationally exposed [Ex. 264, Qs. 24, 42]. OSHA survey data also indicated that approximately 92 percent, or 34,184 (37,157 x 0.92), of all health care workers were occupationally exposed [Ex. 264, Qs. 22, 38]. Housekeepers were identified as being exposed about 10 percent of the time [Ex. 264, Q46]. It was assumed that there would be one housekeeper for each of the 3,497 (34,974 x 0.10) affected health units with occupationally exposed housekeepers, yielding an estimated 3,497 housekeepers affected by the standard. Thus, OSHA estimated the occupationally exposed workforce in this sector to number 178,732.
Health care budgets were not estimated for health units in manufacturing facilities. OSHA assumed the incremental costs of the rule to represent a small portion of the overall cost of manufacturing operations and will have no significant impact on the firms' ability to operate.
Research and Production Laboratories
Exposure incidents in this sector, as in all others, tend to be linked to procedures. Spills, which may cause infectious material to come into contact with non-intact skin, mucous membrane contamination, and cuts with sharp instruments are the most frequent routes of exposure in these facilities [Ex. 13, p. II-125].
OSHA's best estimate of the number of affected establishments in this sector was 1,453. This figure was based on three sources. First, OSHA surveyed commercial research establishments, noncommercial research establishments, and pharmaceutical establishments. From these data, it was estimated that occupational exposure occurs in 496 of 1,873 labs (all 496 would be affected by the standard) [Ex. 264, Q11].
Second, based on U.S. Department of Education (USDE) statistics [1989 Digest of Education Statistics, National Center for Education Statistics, USDE, Table 5], OSHA identified an additional 782 academic institutions doing medical research, which would be affected by the standard. This estimate excludes medical schools and public institutions in states without state administered occupational safety and health programs (judged to be 50 percent of all public institutions).
Finally, based on a survey performed by Booz, Allen, and Hamilton (BAH), and excluding public institutions in non-state plan states, OSHA estimated that about 75 public and private medical schools would also be affected [Ex. 13, p. I-42] (for the purposes of this analysis, these programs were judged to have more extensive medical practice activities than other academic programs).
Also, 1000 faculty and on-site supporting staff per affected medical school were estimated to be occupationally exposed (75,000 workers, total) [Tr. 1/10/90, p. 230]. OSHA identified 100 federal government laboratory complexes would be included in the affected universe [Ex. 13, p. I-42]. Based on the results from the survey, OSHA estimated that 4,636 workers in commercial, noncommercial, and pharmaceutical research labs were occupationally exposed [Ex. 264, Qs. 38, 46, 50, revised]. These workers are scientists, research assistants, laboratory technicians (4,546), housekeeper/janitorial personnel (70), and certain "other" workers (doctors, service workers) (20).
Assuming that the average number of occupationally exposed laboratory workers in non-professional (other than medical and dental) academic and federal labs is similar to that in labs included in the OSHA survey, 7,938 laboratory workers would be at risk in these institutions.
- OSHA estimated the population of exposed housekeepers and "other"
workers in academic and federal labs by computing the ratio of exposed housekeepers and "other" workers to exposed laboratory personnel in commercial, noncommercial, and pharmaceutical research labs (0.015 for housekeepers and 0.004 for "other" workers) and applying these ratios to the population of housekeepers and "other" workers in academic and federal labs. The number of exposed housekeepers in non-professional (other than medical and dental) academic and federal labs was thus estimated to be to 120, and the number of exposed housekeepers in medical school labs was estimated to be 1,125 (75,000 x 0.015). The number of "other" workers exposed in non-professional academic and federal labs was likewise estimated to be to 32, and the number of "other" workers exposed in medical school labs was estimated to be 300.
In sum, the population at risk in this sector was estimated to be 89,151.
Total revenues for commercial, noncommercial, and pharmaceutical establishments were estimated to be $744 million, and assuming average revenue of about $1.5 million [Ex. 264, Q196] for this sector. Additionally, it was estimated that $2.6 billion was spent on the medical sciences in academia and that budgets for federal labs (incorporated here as a proxy for revenues) were about $220 million in 1986 [Ex. 13, p. I-44]. OSHA's best estimate of total revenues for affected establishments in this sector was approximately $3.5 billion. Pre-tax profits for commercial, noncommercial, and pharmaceutical establishments were estimated at $54 million.
Procedures placing funeral home workers at risk of exposure are embalming, cleaning, disinfecting, and transporting cadavers. Embalmers are at risk due to the presence of uncontained blood, and the need to handle various body parts and tissues and to suture incisions [Ex. 11-111, p. 2].
The total number of funeral homes and crematories was estimated to be 20,936. This is based on testimony given in Washington, D.C. by Howard C. Raether, former director of and consultant to the National Funeral Director's Association [Tr. 9/27/89, p. 291]. The OSHA survey indicated that occupational exposure did not occur in all establishments, however. Based on survey results, OSHA estimated 95 percent of the universe, or 19,890 establishments, to be affected by the standard.
OSHA used survey data to estimate the population at risk. Estimates were derived by first multiplying the estimated average number of workers per establishment for each of three categories (morticians, housekeepers, and "other" workers, which included maintenance workers and drivers) by the number of affected establishments. Next, ratios computed from the OSHA multi-sector survey were used to estimate the proportion of workers occupationally exposed. For example, survey data indicated that funeral homes employ, on average, 2.76 morticians [Ex. 246, Q22], and that 93 percent were occupationally exposed [Ex. 264, Qs. 22, 38]. Thus, for all 19,890 affected facilities, OSHA estimated that 51,054 morticians were occupationally exposed. OSHA also estimated 19 percent of 14,321 (2,721) housekeepers were occupationally exposed and 11 percent of 29,437 (3,238) "other" workers were occupationally exposed. In sum, the population at risk for this sector was estimated to be 57,013.
According to census data, revenues for all funeral services and crematories were $5.3 billion in 1987. Thus, average revenue per facility (for the 15,544 facilities enumerated by the census) was $341,000. Multiplying this figure by the number of affected facilities yields an estimated revenue of $6.8 billion industry wide. Associated 1989 pre-tax profit levels for the industry were estimated by OSHA to be about $610 million.
Laundry workers providing services to health care institutions may be occupationally exposed through contact with soiled laundry or concealed sharps.
Based on information in the record, OSHA estimated the number of affected establishments providing linen services to the health care sectors. The Textile Rental Services Association of America (TRSA) reported more than 100,000 workers were employed in over 2,500 establishments in the linen supply and industrial laundry sectors [Tr. 9/25/89, p. 74]. They also indicated that about 50 percent of these establishments handled laundry from health care facilities [Tr. 9/25/89, p. 91]. Based on this information, OSHA estimated that there are approximately 1,250 affected establishments in this sector. The population at risk was estimated to be 50,000.
Total revenue was estimated based on 1987 Census of Service Industries (CSI) data, which indicated average receipts of $1.6 million per linen supply establishment. Total revenue for affected facilities was thus estimated to be $4.8 billion. OSHA estimated pre-tax profits for affected facilities to be $99 million.
Medical Equipment Repair
Exposure to potentially infectious bodily fluids can occur in this sector when "sales, service and repair, quality assurance, and teaching personnel must come in contact with a patient in the hospital, clinic, or the home environment or with contaminated devices" or when "used products are returned to the manufacturer for a variety of reasons," such as replacement or investigation [Tr. 9/25/89, p. 141-2].
OSHA received comments and testimony in which commenters indicated that the Agency underestimated the number of affected establishments in this sector in its preliminary analysis. John A. Matta, senior counsel for PPG industries, explained that no evidence existed in OSHA's preliminary analysis which indicated that manufacturers of clinical laboratory equipment were included, though these companies often provide calibration, maintenance, and repair services to customers [Ex. 20-369, p. 2]. Mr. Matta indicated that over 16,000 medical device manufacturing facilities are registered with FDA. Similarly, David Hopps, representing Ohmeda (a manufacturer of critical care medical equipment) and the Health Industry Manufacturers Association (HIMA), testified in New York that OSHA underestimated the number of affected employees [Tr. 11/14/89, p. 484]. Unfortunately, neither commenter provided estimates of the affected universe or the population at risk. In written comments, however, HIMA indicated that their membership of 320 manufacturers represented "90-95 percent of the commerce in this sector of the health care delivery market [Ex. 20-795]." Additional testimony was received which indicated that about 10 percent of the 200,000 workers employed in the medical device manufacturing industry were occupationally exposed [Tr. 9/25/89, p. 141].
OSHA surveyed establishments in the surgical, medical, and dental instruments and supplies sectors (SIC 384), as well as independent medical equipment repair firms. Additional potentially affected establishments not surveyed included establishments which manufacture laboratory apparatus (SIC 382), or facilities which repair dental/hospital equipment (SIC 7699). Based on Dun and Bradstreet counts, OSHA estimated that there are 1,200 potentially affected firms in these sectors, in addition to the 2,060 firms estimated from data obtained during the OSHA multi-sector survey [Ex. 264, Q11]. Thus, 3,260 establishments were identified.
To estimate the number of firms affected by the standard, OSHA used data from the multi-sector survey. Respondents indicated that occupational exposure occurred in approximately one-third of all medical device establishments surveyed [Ex. 264, Q11]. Thus, OSHA estimated the affected universe to be 1,076 establishments. To estimate the population at risk, OSHA again relied on its multi-sector survey. The average number of occupationally exposed employees per affected establishment was derived from survey data and extrapolated over the entire universe of affected establishments. For example, survey data indicated occupationally exposed unpackers per affected establishment. About 44 percent of establishments surveyed averaged one occupationally exposed unpacker [Ex. 264, Qs. 38, 11]. Extrapolating over the entire affected universe yielded an estimated 473 occupationally exposed unpackers. Performing similar computations for cleaners (200 occupationally exposed [Ex. 264, Qs. 42, 11]), technicians (5,152 occupationally exposed [Ex. 264, Qs. 46, 11]), and sales professionals (360 occupationally exposed [Ex. 264, Qs. 50, 11], OSHA estimated that 6,185 workers are at risk in this sector. The total revenues for this sector were estimated from survey data and indicated average revenue for repair establishments to be about $1 million [Ex. 264, Q196]. OSHA thus estimated revenues to be approximately $1 billion for affected establishments. Pre-tax profits for 1989 were estimated to be approximately $72 million.
Law enforcement personnel are at risk because they may come into contact with blood or body fluids during the course of duty. In testimony presented in Washington, D.C., Ms. Jolanda N. Janczewski stated that she had personally observed numerous situations during which opportunities were present for exposure to contaminated fluids [Tr. 9/12/89]. Examples given included searches of scenes of violent crime and collection and transportation of evidence.
The multi-sector survey's estimate of 4,241 state and local police departments was generated from a sampled universe of 4,273 departments in OSHA state plan states only. The sampling frame used, the National Police Chiefs and Sheriffs Information Bureau, had 12,980 departments listed. The "1987 Profile of State and Local Law Enforcement Agencies" [U.S. Department of Justice, Bureau of Justice Statistics Bulletin] enumerated some 15,118 police departments in the U.S., with the difference resulting from unlisted and uncounted township police departments on the sampling frame. To account for departments not appearing on the sampling frame, OSHA estimated that, in addition to the 4,241 affected departments identified by the survey, 705 departments were affected(3). Thus, OSHA estimated the affected universe to be 4,946 departments.
__________ Footnote(3) This estimate was derived by multiplying the number of departments omitted from the sampling frame, 2,138, by the percentage estimated to be affected, 0.33(4,241/12,980). Footnote(4) Since the township departments were estimated to represent 14 percent of all affected departments (705/4,946), OSHA estimated the percentage of total employment attributable to township departments to be 14 percent. Thus, 237,162/(1-0.14)=275,769.
OSHA's estimate of employment was based upon survey data, adjusted to include federal law enforcement personnel at risk. OSHA derived its estimate of the population at risk as follows.
Based on OSHA's survey, 237,162 state and local police officers were estimated to be at risk [Ex. 264, Q38]. However, this estimate was adjusted to account for township departments not surveyed. Thus, OSHA estimated 275,769 state and local police officers to be at risk.(4) Additionally, based on Bureau of Justice Statistics (BJS) and Census Bureau data, Federal law enforcement personnel at risk were estimated to number approximately 31,000 [Ex. 13, p. I-49].
Laboratory workers are also at risk of exposure to blood and other body fluids in police department labs, as was indicated by information on laboratory procedures submitted by the New York State Police [Ex. 234]. Survey results indicated that 72 percent of lab workers were occupationally exposed, 60 percent of housekeepers were occupationally exposed, and 51 percent of "other" workers were occupationally exposed (including jailers and investigations personnel) [Ex. 264, Qs. 24, 42, 26, 46, 30, 50]. After adjusting survey estimates to account for township departments, 34,777 additional workers were estimated to be at risk in police departments.
In sum, the occupationally exposed workforce for this sector was estimated to be 341,546.
According to BJS, expenditures for state and local law enforcement totalled $28 billion in 1987, with 47.5 percent [Ex. 13, p. I-47], or 13.3 billion, occurring in states with state occupational safety and health plans. OSHA estimated that federal spending was about 14 percent of state and local expenditure levels [Ex. 13, p. I-47]; thus, OSHA estimated federal expenditures on law enforcement to be about $4 billion ($28 billion x 14%) in 1988.
Emergency responders' potential for exposure to blood was described by Mr. Clyde Bragdon of the USFA during testimony in Washington, D.C.:
[f]ire and rescue personnel often come into contact with infectious diseases through routine channels.... In addition to the routine medical emergencies, automobile accidents, and rescues that fire fighters, EMTs, and paramedics respond to, there are numerous other situations unique to these professions where there is a strong potential for occupational exposure to bloodborne diseases. [Tr. 9/14/89, pp. 105-106]
Mr. Bragdon added during questioning that "all firefighters, because of the nature of being first responders, have the potential to be exposed to emergency medical situations" [Tr. 9/14/89, p. 137].
It was estimated, based on information obtained from the National Fire Protection Association's (NFPA) 1987 U.S. profile, that 3,174 fire/emergency medical service (EMS) departments, public and private, will be affected by the standard [Ex. 13, p. I-51]. Although testimony presented in Washington, D.C. by the United States Fire Administration (USFA) indicated that approximately 34,000 departments exist across the country [Tr. 9/14/89, p. 103], the bloodborne pathogens standard applies only to departments with paid employees, in states with occupational safety and health plans. The American Ambulance Association (AAA), with a membership of 500, also testified, reporting their estimate that close to 5,000 private organizations provide EMS services [Tr. 1/17/90, p. 881]. OSHA relied on NFPA data for this analysis.
The population at risk for fire and rescue departments consists principally of fire fighters and emergency medical technicians (EMTs), or paramedics. OSHA's best estimate of the number of paid fire fighters is 170,515 [Ex. 13, p. I-53], and is based on NFPA data. Information was also received into the record regarding the population of emergency medical technicians (EMTs). Mr. Paul Maniscalco, representing the National Association of Emergency Medical Technicians (NAEMT), testified that, "based on the 1988 Survey of Emergency Medical Technician Population... the aggregate of EMTs in the OSHA states is 282,408" [Tr. 9/14/89, p. 126]. No indication was given as to how many of these EMTs were volunteers. Also, it is likely that a large number of these EMTs are fire fighters [Tr. 9/14/89, p. 183; Seattle Fire Fighters Union and San Antonio Professional Firefighters Association, Ex. 22-122].
To estimate the number of EMTs affected by the standard, OSHA first deducted from the estimated 282,408 EMTs in state-plan states all EMTs believed to be paid fire fighters. Incorporating its assumption that 50 percent of all cities with fire departments also had separate EMS units, OSHA assumed 50 percent of municipalities in state plan states have no separate EMS unit; thus, OSHA estimated that approximately 85,258 EMTs are also paid fire fighters (170,515 x 0.50). Next, it was assumed that public EMS departments separate from fire departments in state plan states require about the same number of paid paramedics (85,258). Finally, using OSHA's best estimate of the number of EMS workers who are employed by private ambulance companies in state plan states, 15,466 (30,932/2) [Ex. 13, p. I-53], OSHA estimated that 96,426 EMTs in state plan states are volunteer (282,408 - (85,258 + 85,258 + 15,466)). The total number of EMTs affected by the standard in state plan states was thus estimated to be 100,724 (85,258 + 15,466).
In total, employment among firefighters and EMTs in state plan states was estimated to be 271,240 (85,258 fire fighters, 85,258 fire fighters/EMTs, 100,724 EMTs, public and private). An additional 15,466 private EMTs were also estimated to be employed in states without state plans.
OSHA based its estimate of the population at risk on survey responses which indicated essentially all EMTs to be exposed (98 percent [Ex. 264, Q38]) and 80 percent of all firefighters to be exposed [Ex. 264, Qs. 24, 42](5). OSHA also estimated 885 public health care professionals, vehicle maintenance, and equipment technicians to be at risk in state plan states [Ex. 264, Q50]. An additional 885 health care professionals, vehicle maintenance, and equipment technicians were estimated to be at risk in states without state plans. Thus, in sum, OSHA estimated the population at risk for this sector to be 252,048.
__________ Footnote(5) These calculations were performed in a manner similar to that described for the home health sector. See Footnote (2).
Expenditures on fire protection in state plan states was estimated to be approximately $4.0 billion [Ex. 13, p. I-52]. No data were received regarding revenues for private ambulance companies.
Situations putting correctional employees at risk of exposure include violence and emergency medical treatment, and sharps (syringes).
OSHA identified an estimated 1,158 local jails, 762 state prison establishments, and 71 federally administered prison establishments, exclusive of state and locally administered facilities in states without occupational safety and health plans. These estimates were based on the Bureau of Justice Statistics' (BJS) 1988 Census of Local Jails [U.S. Department of Justice, Bureau of Justice Statistics] and the OSHA multi-sector survey (OSHA surveyed state and federal facilities).
Results from the OSHA survey indicated that employees were occupationally exposed in about 95 percent of state prisons and 100 percent of federal prisons [Ex. 264, Q11, revised]. OSHA had no data regarding prevalence of occupational exposure at local jails; thus, OSHA assumed that employees were occupationally exposed in 95 percent of local jails, as well. Thus, 1,895 correctional facilities are estimated to be affected by the rule. OSHA estimated that 120,224 workers were at risk in correctional facilities. In state and federal institutions, 57,883 custodial and security employees, 8,381 health care workers, 7,273 housekeepers, and 21,687 "other" workers (maintenance workers and paid prisoners) were estimated to be occupationally exposed, based on OSHA's survey [Ex. 264, Qs. 38, 42, 46, 50, revised]. To develop estimates of the number of occupationally exposed correctional staff in local jails, OSHA relied on 1988 BJS data, adjusted to exclude workers not occupationally exposed. Based on OSHA survey data, it was estimated that 67 percent of correctional staff in state and federal institutions were occupationally exposed [Ex. 264, Qs. 24, 42, revised]. Thus, it was estimated that of 73,280 correctional officers in local jails, 49,098 were occupationally exposed, of which approximately 25,000 were estimated to be employed in state plan states. (BJS data did not allow OSHA to develop estimates for other categories of employees.) Expenditures for local correctional facilities in state plan states was estimated to have reached $2.5 billion in fiscal year 1988 [1988 Census of Local Jails, U.S. Department of Justice, Bureau of Justice Statistics]. OSHA estimated that expenditures made by state administrations were about double that of local governments [Ex. 13, p. I-92]; thus, OSHA estimated expenditures on state correctional facilities to be approximately $5.0 billion in 1988. Federal government spending on corrections was reported to be $779 million in 1985. OSHA estimated 1988 federal expenditures to be approximately $1 billion. Total expenditures for this sector are estimated to be $8.5 billion.
Teachers and instructional aides in facilities where instruction is provided for the developmentally disabled are at increased risk due to children's vulnerability to injury, special medical needs, and dependence on adults for personal care [Tr. 1/12/90, pp. 487-501].
U.S. Department of Education (USDE) data indicated that during the 1986-87 academic year, teachers of the developmentally disabled taught 601,288 students, or 14.6 percent of all children classified with specific handicaps ["Eleventh Annual Report to Congress on the Implementation of the Education of the Handicapped Act, 1989," USDE]. The numbers and percentages of students receiving their education in a variety of locations are: regular classes within public schools (33,711, or 5.68 percent); resource rooms within public schools (142,341,or 23.97 percent); separate classes within public schools (341,958, or 57.59 percent); separate public facilities (60,815, or 10.24 percent); separate private facilities (6,847, or 1.15 percent); public residential facilities (3,767, or O.63 percent); private residential facilities (2,316, or 0.39 percent); and homebound hospital environment (2,041, or 0.34 percent). Thus, over 98 percent of developmentally disabled students were instructed in public facilities.
Based on USDE data, OSHA estimated 23,514 teachers of the developmentally disabled to be employed in school districts located in states with occupational safety and health plans. Testimony presented in San Francisco by the California School Employees Association indicated that staff other than teachers were occupationally exposed [Tr. 1/12/90, pp. 495-497]. An estimated 17,848 staff other than teachers will also be covered by the standard [derived from the "Eleventh Annual Report to Congress on the Implementation of the Education of the Handicapped Act, 1989", USDE].
OSHA estimated the number of affected school districts to be 6,321 ["Eleventh Annual Report to Congress on the Implementation of the Education of the Handicapped Act, 1989", USDE].
Data on finances for public school systems were not submitted to the record. Data were available, however, from recent publications. Based on data from the National Education Association (NEA), total school system revenues nationally for the 1985-86 school year approximated $160 billion with the federal government providing about $10 billion (6.3 percent); state governments funding $75.5 billion (47.3 percent); local governments providing $67.2 billion (42.1 percent) and nonrevenue receipts (i.e., bonds) supporting $7 billion (4.3 percent) ["Estimates of School Statistics", National Education Association, 1988].
Nationally, school systems spend approximately $2.8 billion educating 601,288 developmentally disabled students. This estimate is based on a $4,615 per student cost according to the U.S. Department of Education. The regulations will affect every state and probably most school districts because the data indicate that every state has one or more settings for educating its developmentally disabled citizens [Supplement to "Patterns in Special Education Service Delivery and Cost, Report for Department of Education by Decision Resources Corporation", 1988].
Exposure of lifeguards to bloodborne pathogens comes from saving and performing life saving procedures on victims of swimming, boating or fishing accidents. One dangerous aspect of their work is that lifeguards usually cannot use personal protective equipment during the rescue operation; lifeguards do not have access to dry dressings and gloves in the water. They use their bare hands to apply direct pressure to stop a victim's bleeding.
The first possibility of exposure in a rescue, therefore, is due to the "prolonged and extensive direct contact... between the rescuer and his victim" in the presence of body fluids [Tr. 12/20/89, p. 1139]. This may include blood contact from holding the victim or saliva contact from administering "mouth-to-mouth resuscitation" [Tr. 12/20/89, p. 1139].
A second avenue of exposure is medical waste that has been thrown or washed up on beaches. One report noted that a lifeguard stepped on a hypodermic needle while walking on the beach, subsequently receiving a gamma globulin vaccination [Tr. 12/20/89, p. 1173].
Testimony indicated approximately 10,000 ocean lifeguards to be at risk [Tr. 12/20/89, p. 1258]. OSHA estimated that up to 5,000 ocean lifeguards may be subject to the final rule. This estimate includes only state and local government employees who are employed in states with occupational safety and health plans. There was no testimony or public comment on private lifeguards. Assuming average employment during the summer is approximately 50 full-time, part-time, and on-call lifeguards, OSHA assumed 100 ocean rescue departments to be affected by the rule [Tr. 12/20/89, p. 1294].
No data were available on expenditures for the lifesaving sector. OSHA's budget estimate for this sector was based on expenditures for fire and rescue services, since both sectors practice similar paramedic type activities. Based on OSHA's estimated level of spending of $4.0 billion in the fire and rescue sector, expenditure per exposed employee was estimated to be $13,925; thus, OSHA estimates that expenditures for lifesaving services were approximately $140 million.
Evidence in the record indicated that waste handlers are at risk of occupational exposure. For example, Brown-Ferris Industries Corporation (BFI) reported a medical-waste related needle injury rate of over 11 injuries per 1,000 workers annually [Ex. 286D, p. 5.28].
While it is estimated that there are over 200,000 refuse collectors [Ex. 286D, p. 2.8], not all of these workers will be involved specifically in the collection of medical waste. BFI reported that 2,700 employees worked specifically with medical waste, while 24,800 worked with municipal waste [Ex. 286D, p. 5.28]. No other data were available which would allow the Agency to derive estimates of the population at risk for this sector; thus, assuming that this ratio is typical throughout the industry, OSHA estimated about 10 percent of all waste handlers, or 20,000, were occupationally exposed. However, this estimate includes public sector workers in states without occupational safety and health plans who are not covered by Federal OSHA regulations. For the purposes of this analysis, OSHA assumes that two-thirds (67 percent) of all workers specifically handling medical waste are public employees. OSHA also assumes that 50 percent of all public sanitation workers are employed in states without occupational safety and health plans. Thus, OSHA estimates that 6,700 public and 6,600 private sanitation workers will be affected by the standard.
OSHA was not able to accurately estimate the number of affected establishments for this sector, since existing data combine private waste haulers and publicly administered sanitation services.
The Agency for Toxic Substances and Disease Registry estimated that 500,000 tons of regulated medical waste is generated by 380,000 regulated generators in industry hospitals, physicians' offices, dentists offices, biomedical research facilities, clinical laboratories, manufacturing facilities, veterinary offices and clinics, funeral homes, in-home medical care, other health care and residential care facilities and illicit intravenous drug users [Ex. 286D, pp. 3.13-3.36]. Unit costs of disposal were estimated by OSHA to range from $0.44 to $0.75 per pound (see Appendix C). Thus, OSHA estimated average annual expenditures on removal of regulated medical waste to be $440 to $750 million.
Approximately one-half of total expenditures were estimated to be directed toward proprietary operations. Estimated pre-tax profits, based on an average estimated annual revenue figure of $300 million for such operations, were estimated by OSHA to be $22 million in 1989.
OSHA's standard to reduce occupational exposure to bloodborne pathogens, including hepatitis B virus (HBV), non-A, non-B hepatitis virus, and human immunodeficiency virus (HIV), includes provisions applicable to the wide range of occupational settings where potential exposure to such bloodborne pathogens exist. In this section, OSHA presents its estimates of the expected reduction in disease cases among the employees affected by the standard.
2. Hazard Abatement
OSHA's standard for reducing worker exposure to bloodborne pathogens is based on the adoption of universal precautions as a method of infection control. This approach, which is fundamentally different from traditional procedures that isolate known infectious individuals and materials in the health care setting, assumes that all human blood and body fluids are potentially infectious for HIV, HBV, and other bloodborne pathogens. The rationale for this approach is that carriers of these diseases are not always identifiable in the health care setting, and that contaminated materials are not always properly labeled. Thus, the exposed worker can be at great risk without warning.
The standard will apply to widely varying workplace settings, including research laboratories, funeral homes, hospitals, prisons and police and fire departments. Hazard abatement measures will be developed by the employer to best suit the work place setting and accomplish the common objective of protecting the worker from contact with potentially infectious blood and body fluids and other potentially infectious materials.
In implementing the standard, employers will first develop an exposure control program that identifies the tasks and/or positions associated with occupational exposures to blood or other potentially infectious materials and which documents the schedule of implementation of the measures that will be used to reduce potential risk. Employers will also be required to develop procedures to evaluate the circumstances surrounding exposure incidents.
The development of procedures to evaluate the circumstances surrounding exposure incidents is critical to reducing risk associated with bloodborne pathogens. Data in the record indicated that an emphasis on education, enforcement, and monitoring was associated with an increase in reporting of exposure incidents [Tr. 12/19/89, pp. 864-868]. Thus, to the extent that the OSHA standard increases employee awareness and compliance with employers' exposure control policies, promulgation of the standard will result in an increase in such reporting. Data indicated increased reporting of incidents could result in the reduction or elimination of certain exposure hazards, once such hazards are identified [Tr. 12/19/89, p. 868; Ex. 20-655, p. 2]. One example was provided for the record by Dr. Janine Jagger, Assistant Professor of Neurosurgery at the University of Virginia's Health Sciences Center [Ex. 300]. This submission demonstrated how accurate incident reporting and recordkeeping will support risk managers in their analysis and prioritization of alternative solutions to various types of needle injuries. Documenting the circumstances of exposure will contribute to overall risk reduction by allowing risk managers to more efficiently focus resources on exposure problems and ensure that other provisions of the standard are implemented in a timely manner to reduce or eliminate risk.
Another requirement of the standard is that the employer shall offer HBV vaccine to occupationally exposed employees. HBV vaccination is a means of achieving substantial reduction in the risk of infection for non-immune employees. In testimony provided by a manufacturer of the vaccine, the immunogenicity rate for employees covered by the OSHA standard was estimated to be 96 percent [Ex. 292]. A weighted average of OSHA's survey data on vaccine acceptance rates indicated that 50 percent of employees offered the vaccine would accept. Some may argue that the acceptance rate should be higher due to the provision requiring workers to sign a declination form if they refuse the vaccine. OSHA acknowledges that although the declination form is not a waiver, and the employee reserves the right to accept the vaccine at a future date, signing such a form may cause workers to think twice about turning down the offer and thus, result in a higher acceptance rate. However, there is no available data which would allow such an effect to be quantified.
The standard also requires post exposure evaluation and treatment. This includes testing to determine whether there has been transmission of infection, and follow-up treatment and counseling.
In the case of exposure to HBV, follow-up treatment can prevent illness. Under the standard, employers must offer safe and effective post-exposure prophylaxis, and hepatitis B immune globulin (HBIG) injections will be administered to employees experiencing exposure incidents. This post-exposure treatment appears to be highly effective in preventing HBV infection when an exposed employee lacks anti-HBs [Ex. 6-45].
This is another example of the importance of reporting exposure incidents. Since promulgation of the OSHA rule is expected to increase incident reporting, OSHA estimated an increase in the proportion of potentially infected workers receiving post-exposure prophylaxis, thereby preventing illness. The requirements under this provision of the standard will also assure that workers not presently provided access to prophylaxis (results of OSHA's multi-sector survey indicated many facilities were not offering such treatment to employees) will be offered treatment under the standard.
Counseling will reduce risk, through modification of the behavior of workers acquiring infection. These workers will be less likely to infect sexual partners or neonates (newborn children).
Training will be an integral part of overall risk reduction. In a series of case studies conducted by Jack Faucett Associates, hospitals reported that one of the most important aspects of employee compliance with infection control programs was an understanding of the risk [Volume III: Hospital Case Studies, Ex. 13, pp. 20, 48, 82, 123]. The employee training that conveys this risk becomes an indispensable link in hazard abatement. This requirement of the standard assures maximum effectiveness of most other provisions of the standard.
Work practices can have a substantial impact on hazard abatement by altering the manner in which a task is performed or by ensuring that equipment designed to prevent occupational exposure, such as engineering controls or PPE, is used in a manner which maximizes its effectiveness. The importance of strict adherence to work practice controls was reflected by evidence in the record. For example, the American Association of Bioanalysts stated their position that:
[h]ealthcare workers exposed to blood, body fluids, or tissues can be protected from the risk of infection with HBV and HIV by imposing the use of... clothing, masks, gloves, and other protective equipment. These protective barriers must be coupled with mandated operating procedures combining education and enforcement of safe handling regimens for all specimens. [Ex. 237, p. 1]
The authors of one study concluded that the breakdown of good work practices most likely led to the contamination of environmental surfaces in an autopsy suite, and that their results "underscore the importance of establishing and consistently following good work practices and cleanup procedures to minimize the risk of exposure..." [Ex. 260F (Beaumont)]. Like training, this requirement contributes to overall risk reduction by assuring maximum effectiveness of other provisions of the standard.
The standard also requires that engineering controls be used. As described below (see Technological Feasibility), engineering controls are available to reduce risk of occupational exposure by confining or isolating infectious material. Evidence clearly indicated the potential for risk reduction associated with the use of equipment designed to greatly reduce or eliminate the risk of accidental exposure [Tr. 9/15/89, p. 160; "Estimated Cost of Needlestick Injuries for Six Major Needled Devices," Ex. 300, p. 11].
Personal protective equipment (PPE) is a direct line of defense for health care workers whose exposure occurs through non-intact skin or mucous membrane contact with blood or other potentially infectious materials. Evidence submitted regarding the effectiveness of PPE in reducing risk included a study of embalmers in an urban area which identified factors associated with risk of HBV infection. Specifically, embalmers not wearing gloves routinely were found to be ten times more likely to have serologic markers of HBV infection than those who did [Ex. 6-549, p. 1425]. Another study found that in clinical laboratories "the portal of entry for the HBV is subtle and most likely through inconspicuous breaks in the skin or contact with mucous membranes" [Ex. 260A (Lauer)]. Since PPE isolates such portals of entry from potentially infectious materials, its proper use was judged to be a highly effective approach in preventing infections due to this mode of transmission.
The housekeeping provisions of the standard, including the provision for disposal of regulated waste, contribute to overall risk reduction by ensuring that work areas and equipment are kept free of contamination and that potentially infectious materials destined for disposal are packaged so as to isolate them from the workforce.
Also, under the standard, laboratories producing HIV for research or laboratories concentrating these viruses will be required to establish procedures according to paragraph (e) of the standard. These procedures were based on accepted industry practice. As documented [54 FR 23057], HIV infection has occurred in the laboratory environment, thus emphasizing the importance of implementing stringent infection control practices in this facility type.
Table VII-4 identifies by SIC code and facility type OSHA's estimates of the total number of workers at risk of exposure to HBV and HIV. "Health Care Workers" includes all workers, regardless of occupation, employed in health care providing establishments and health care professionals in non-health care facilities (i.e. correctional facilities, personnel services, etc.). As shown in the table, the population-at-risk to HBV infection is smaller than the population at risk to HIV infection. This is because prior exposure or vaccination may result in immunity to HBV infection.
TABLE VII-4 - POPULATION AT RISK _______________________________________________________________________ AFFECTED AFFECTED AFFECTED SIC FACILITY TYPE WORKFORCE WORKFORCE WORKFORCE AT RISK TO AT RISK - HBV AT RISK - HBV HIV 15% 1MM.(a) 30% 1MM,(a) _______________________________________________________________________ HEALTH CARE WORKERS: 806 HOSPITALS 2,386,165 1,163,655 958,304 802 DENTAL OFFICES 316,237 97,066 79,937 801; PHYSICIANS' 803 OFFICES 640,681 313,206 257,934 807 MEDICAL AND DENTAL LABS 62,854 33,703 27,755 805 NURSING HOMES 485,303 367,944 303,013 836 RESIDENTIAL CARE FACILITIES 49,102 29,461 24,262 808 HOME HEALTH 212,246 141,703 116,697 (b) HOSPICE CARE 10,856 7,142 5,881 8092 HEMODIALYSIS 12,688 3,977 3,275 8093 DRUG TREATMENT 6,722 3,110 2,561 9431 PUBLIC CLINICS 56,345 27,533 22,674 8099 BLOOD BANKS AND OTHERS 18,788 9,841 8,105 (b) INDUSTRIAL FACILITIES 34,184 20,688 17,038 9223 CORRECTIONAL FACILITES 8,381 5,688 4,684 7362 PERSONNEL SERVICES 61,387 46,168 38,021 ______________ ____________ __________ 4,361,940 2,270,883 1,870,139 OTHER EMPLOYEES AT RISK: 7362 PERSONNEL SERVICES 102,090 86,777 71,463 726 FUNERAL HOMES 57,013 32,903 27,096 (b) INDUSTRIAL FACILITIES 144,548 103,299 85,070 8221; RESEARCH 873; LABORATORIES 89,151 42,583 35,068 283 721 LINEN SERVICES 50,000 42,500 35,000 38; MEDICAL 7699 EQUIPMENT REPAIR 6,185 4,843 3,988 9221 LAW ENFORCEMENT 341,546 241,402 198,802 9224 FIRE AND RESCUE 252,048 89,586 73,777 9223 CORRECTIONAL FACILITIES 111,843 92,678 76,323 9229 LIFESAVING 5,000 3,230 2,660 9411 SCHOOLS 41,362 35,158 28,953 4953; WASTE 9511 REMOVAL 13,300 11,305 9,310 ____________ ______________ ___________ 1,214,086 786,262 647,510 ______________________________________________________________________ TOTALS 5,576,026 3,057,145 2,517,649 (a) Totals assume vaccination efficacy to be 0.96. (b) Includes various SIC codes. ______________________________________________________________________ Source: Occupatonal Safety and Health Administration, Office of Regulatory Analysis, 1991.
4. Quantification of Benefits
Employees exposed to infectious materials are at risk of contracting a variety of diseases associated with bloodborne pathogens. However, OSHA has not been able to quantify all of the potential benefits expected from the standard.
With respect to AIDS, the relatively short history of the HIV epidemic has made it difficult to develop a precise projection of the number of job-related AIDS cases that will be averted. It is known that the probability of HIV transmission in most workplace settings is low, and to date, 24 cases of HIV infection associated with occupational exposure have been documented (see Health Effects). Four of these cases have developed into AIDS. Nonetheless, the prevalence of AIDS continues to climb among the general population, and in the absence of strict exposure control, the rate of occupational risk will grow accordingly.
Similarly, available information did not allow OSHA to develop a quantitative estimate of the benefits associated with a reduction in non-A, non-B hepatitis infections. However, it is clear that the standard should provide protection to workers from these illnesses since, like hepatitis B, at least one of the several viruses which cause non-A, non-B hepatitis is transmitted primarily by direct exposure to blood [Tr. 9/14/89, p. 23]. It was estimated that 3,400 non-A, non-B hepatitis infections were attributable to occupational exposure in 1988 [Ex. 298, p. 5]. It was also reported that non-A, non-B viruses cause between 15 and 35 percent of acute hepatitis cases in the U.S., with 40 to 60 percent of the infections leading to chronic hepatitis and the potential for death [Tr. 9/14/89, p. 24].
The risk of contracting hepatitis B at the workplace has been studied for many years. For the purposes of this rulemaking, OSHA relied on a nationwide annual risk estimate of health care workers contracting hepatitis B infections. This use of a nationwide estimate is necessary because data were lacking for many sectors covered by the rule. Partial data concerning risk were introduced for some sectors, including blood banks. However, OSHA did not develop separate risk estimates for these sectors because of the large variations in the statistics provided, and in some cases, the lack of underlying data and supporting documentation. The studies did, however, emphasize the effectiveness of and need for safety measures in reducing the risk of contracting HBV infections.
Data were submitted to the record specific to the risk of workers in blood banks. The American Association of Blood Banks (AABB) submitted comments to the record suggesting that health care workers handling donor blood are at lower risk than other occupations [Ex. 10-1059]. AABB cites a study by the South Central Association of Blood Banks in which 33 blood centers were surveyed and no cases of HIV or HBV infection were reported. However, these data are of limited use due to the lack of supporting documentation. No data were provided on the number of workers covered, the number of donors or the number of donations. There was also no information on any protective measures already taken at the facilities. More importantly, the results do not establish an absence of risk for blood bank workers and may be consistant with the average estimated average risk in this sector.
AABB also cites a study of Southwest Florida Blood Bank, which indicated that 56 accidental exposures occurred over a four year period in a facility which draws over 1,000 donors per week, and none of the exposures resulted in HBV or HIV infection. These data only allow conclusions to be made about the blood involved in the 56 cases of accidental exposure and does not allow any conclusions to be drawn on the overall quality of blood collected. Furthermore, there is no information whether the facility was already taking precautions to prevent infection. This study generally supports the conclusion that blood bank workers are exposed to the risks of HBV infection.
The American Red Cross submitted comments on the risk of HBV infection in blood banks. Hanson and Polesky conducted a study of incidences of Hepatitis-B cases among workers over a 10 year period in War Memorial Blood Bank in Minneapolis [Ex. 20-784, Attachment 4]. The study determined an annual incidence rate for the facility of 1.4 percent, over 5 times higher than the risk used in OSHA's analysis. The study indicated that of the 185 people tested, 11 became HBV infected. However, no clinical cases of HBV infection occurred after 1977.
The decrease in HBV infections noted during the study period was inversely proportional to the increase in reported accidental exposures. This suggests that a heightened awareness of the potential risks and prophylactic treatment of exposures was a factor in reducing HBV infection. [Ex. 20-784, Attachment 4, p. 20]
Furthermore, the study noted that of the 16 subjects employed in hepatitis testing, none become HBV infection. Hanson and Polesky indicated that "the lack of infection in this high risk area was due to awareness of the potential infectivity of the blood samples handled and strict enforcement of safety measures." [Ex. 20-784, Attachment 4, p. 20]
The study also concluded that routine surveillance may be useful in identifying procedures or work areas that present increased risk to employees. In addition, it provides a mechanism for periodically reminding personnel of the potential risks associated with handling blood and other body fluids. [Ex. 20-784, Attachment 4, p. 20]
The first part of the statement suggests the need for exposure control. OSHA's standard requires employers to make exposure determinations by identifying all job classifications and procedures in which occupational exposure may occur. The standard also requires employers to maintain, periodically update, and make available to employees an exposure control plan which includes information in the exposure determination and all the safety precautions required in the standard.
The study results suggest that workers handling donor blood may be at lower risk than workers handling patient blood samples. However, there is still a risk from first-time donors and certain high-risk populations. The need for safety precautions is stressed.
Hanson and Polesky state that workers in blood banks may not be at higher risk than the general population. However,
[t]he introduction of high-risk patient samples may significantly alter the attack rate unless appropriate precautions are used. In this setting the establishment of safety precautions are effective means of preventing HBV infection. [Ex. 20-784, Attachment 4, p.20]
This study emphasizes the need for safe work practices such as those being required under OSHA's Bloodborne Pathogens rule, including the use of personal protective equipment; engineering and work practice controls; and training to increase awareness of the hazard and to reinforce the need for safety precautions.
The second study cited by the American Red Cross done by P.L. Page of the Northeast Region of Red Cross Blood Services states that worker in American Red Cross Blood Centers in this region are at lower risk than workers in hospital blood centers [Ex. 20-784, Attachment 5]. The incidence rate provided for the Northeast Region over a 3 year period was 5.4 percent. However, the study also provides statistics on the prevalence of HBV infection in other blood centers. A regional center in Kansas City had a 0.9 percent rate for workers with blood contact. In eight Red Cross Blood Services Regions, the rate was 8.8 percent for workers with no previous work involving blood contact, and 20.4 percent for workers with a history of work involving blood contact outside the centers. The great variation in these statistics supported the use of an average risk estimated across the affected population.
The American Red Cross states that the overall rate of infection among its donors is 0.035 percent. The American Red Cross also indicates that 15 percent of the donors are "first time" donors not previously tested for HBV [Ex. 20-784, p. 3]. This suggests that there remains an unidentifiable risk in 15 percent of the donors. Furthermore, American Red Cross deals with patients as well as donors. When workers deal with patients, they are required to wear gloves.
OSHA believes that any worker who handles blood products is at risk since there is no way of telling whether in fact a donor is infected. Furthermore, the nature of the hazard is such that a single exposure to HBV infected blood is all that is required for a worker to become infected. Study data showed a large variation in the infection rate among exposed workers in blood banks. OSHA used an average rate covering workers in all sectors based on the number of CDC documented HBV infection cases among health care workers.
The Centers for Disease Control (CDC) reported 8,700 cases of Hepatitis B infection occurred among the universe of health care workers in the U.S. in 1988. (OSHA estimates that a universe of 4,897,595 health care workers are at risk.) From survey data, OSHA estimated the number of workers who have already received the hepatitis B vaccine. OSHA assumed that 15 to 30 percent of workers have acquired lifetime immunity from prior occupational exposure to Hepatitis-B (see Preliminary Risk Assessment). The population at risk was estimated by subtracting the number of people vaccinated (times the 96 percent efficacy rate of the vaccine) and the immune population. OSHA used the number of HBV infections reported by CDC to determine the annual rate of occupationally-induced HBV infection. For health care workers, annual occupational risk was estimated to range from 3.47 per thousand (assuming a 15 percent immune population) to 4.21 per thousand (assuming a 30 percent immune population). The rate of infection is higher with a 30 percent immune population, since the same number of HBV infections is spread over a smaller population at risk (hence, a greater number of infections per thousand). Furthermore, the size of the immune population is directly related to the prevalence of HBV exposure. For non-health care workers, occupational risk was estimated to be similar. (This level of risk equates with an annual rate of infection of about 4,400 total cases for non-health care workers, about one-half the total estimated to occur in health care workers.) Next, OSHA addressed the potential benefits of the vaccine provision by estimating the annual number of cases of each hepatitis B-related condition that would be avoided by offering all affected employees the opportunity for vaccination. In performing these calculations, OSHA subtracted the background risk of HBV infection (risk for U.S. adult population) from the rates of infection for workers and applied these rates to the affected population at risk. Based on survey data, OSHA assumed that 50 percent of the workers would accept the offer of free vaccination. OSHA used this vaccine acceptance rate and the 96 percent efficacy rate of the vaccine to determine the number of HBV infections avoided. The results for occupationally-induced HBV cases are shown in Table VII-5.
The first two columns of Table VII-5 present estimates of the baseline annual incidence of work-related cases of HBV infection and the number of such cases avoided annually following the implementation of the new vaccination programs. As shown, for workers covered by the standard, OSHA estimated that the current number of occupationally-related cases is between 5,814 and 6,645 per year, depending on current rates of prior immunity, of which almost half could be prevented by offering vaccination.
TABLE VII-5 - ANNUAL BASELINE CASES AND CASES-AVOIDED OF OCCUPATIONALLY-INDUCED HEPATITIS B CASES AVOIDED TOTAL DUE CASES BASELINE CASES TO VACCINE AVOIDED ______________________________________________________________________ HBV INFECTIONS 5,814 - 6,645 2,791 - 3,190 5,058 - 5,781 ACUTE SYMPTOMS 1,454 - 1,661 698 - 797 1,265 - 1,445 HOSPITALIZED 291 - 332 140 - 159 253 - 289 FULMINANT DEATH 7 - 8 3 - 4 6 - 7 HBV CARRIER 291 - 664 140 - 319 253 - 578 CRONIC HB 73 - 166 35 - 80 63 - 145 DEATH CIRRHOSIS 99 - 113 47 - 54 86 - 98 DEATH PHC 23 - 27 11 - 13 20 - 23 ALL DEATHS 129 - 148 62 - 71 113 - 129 ______________________________________________________________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Since many workers may choose to decline the employers' offer of vaccination, and since the vaccine is not 100 percent effective, workers at risk who will not be protected by vaccination must rely on the other provisions of the standard, including engineering controls, work practices, personal protective equipment, post-exposure follow-up, housekeeping and training, for protection against occupationally acquired infections.
OSHA preliminarily estimated the effectiveness of these additional provisions to protect workers not protected by vaccination to be 75 percent. Though commenters expressed concern regarding this estimate [Exs. 20-655, pp. 3-4; L20-2943], data in the rulemaking record supported OSHA's preliminary calculations.
Data clearly indicated the number of exposure incidents could be reduced by measures required under the rule. As noted above, employees in one occupational category not routinely wearing gloves were found to be ten times more likely to have serologic markers of HBV infection than those who did [Ex. 6-549, p. 1425]. This suggests a substantial reduction in risk was associated with glove use alone for this occupation. The evidence leads OSHA to conclude that a 75 percent reduction in incidents, on average, due to non-intact skin or mucous membrane exposure is likely when PPE is used in a manner consistent with the requirements of the rule [Exs. 260A (Lauer); 237, p. 1].
With regard to percutaneous incidents, such as needle-stick injuries, evidence indicated that the majority of the most common injuries were preventable. For example, based on data in the record, OSHA estimated that about 75 percent of all exposure incidents caused by disposable syringes and 90 percent of all exposure incidents caused by pre-filled cartridge syringes could be prevented by using syringes which incorporate resheathing or retracting designs ["Estimated Costs of Needlestick Injuries for Six Major Needled Devices," Ex. 300, p. 11; Ex. 6-350, p. 286]. Since these data also indicated these injuries constituted 75 percent of reported percutaneous injuries associated with exposure to potentially infectious fluids (excluding IV tubing), OSHA estimated that needle-stick incidents could be reduced by more than 50 percent by implementing these engineering controls.
Further, evidence was presented which supported OSHA's position that following implementation of the standard, incident reporting will improve. The implications of this reporting were demonstrated to be: 1) in conjunction with the documentation of circumstances surrounding incidents, increased reporting leads to a better understanding of hazards, which in turn can lead to corrective action with respect to previously unsuspected hazards (thus ensuring maximum effectiveness of all provisions of the standard); and 2) increased reporting can lead to an increase in prophylactic treatment, thereby preventing additional cases of potential HBV infection. These benefits were estimated to be significant, as OSHA found that "reported injuries do not account for the majority of infections in health care workers" [54 FR 23050/3].
As noted in OSHA's preliminary analysis, the effectiveness of the non-vaccine provisions in reducing the incidence of HBV infections was exemplified by the experience of a large mid-western hospital, where less than 20 percent of the high-risk employees chose to receive the vaccine. Still, this facility was able to reduce its incidence of reported HBV infection from 160 cases during a two year period in the early 1970's to one case in 1985 and none in 1986 and 1987 [Ex. 13, volume III, p. 88]. This was accomplished through the establishment of a comprehensive program of infection control practices, including aggressive post-exposure protocol, and supports OSHA's belief that although HBV vaccination is a key protective measure, a very high degree of disease avoidance can be maintained through ancillary infection control practices.
In a study submitted by the American Red Cross, conducted by Hanson and Polesky of War Memorial Blood Bank in Minneapolis, the effectiveness of safety precautions is emphasized. The reduction in HBV infections seen in the study was believed to be attributable to the "strict enforcement of safety measures." The study further emphasizes that exposures to blood samples from patients who may be high risk:
may significantly increase alter the attack rate [of the hepatitis B virus] unless appropriate precautions are used ... the establishment and enforcement of safety precautions are effective means of preventing HBV infection. [Ex. 20-784, Attachment 4, p. 20]
OSHA recognizes that the effectiveness of the non-vaccine provisions of the rule may be higher or lower. However, OSHA maintains that, with the combination of PPE, training, engineering and work practice controls, and the other non-vaccine provisions of the standard, its preliminary estimate of 75 percent is a reasonable estimate of the effectiveness of these provisions.
In total, considering the full combination of provisions, including vaccination, engineering controls, work practices, protective clothing, housekeeping, and training, OSHA estimated that 87 percent of occupationally induced HBV cases exposure could be avoided. The final columns of Table VII-5 display OSHA's estimate that compliance with the standard will prevent between 5,058 and 5,781 occupational cases of HBV infection per year, of which 1,265 to 1,445 would have resulted in acute symptoms, and 113 to 129 in death.
Moreover, a considerable amount of additional illness will be prevented since the vaccine will also prevent workers from contracting HBV while off the job; that is, the vaccine will also reduce non-occupational risk. Since about 30 percent of those with acute infections in turn infect sex partners and over 50 percent of pregnant women pass the disease on to infants, additional risks associated with non-occupational transmission will be reduced. OSHA estimates that the standard will prevent between 253 and 578 employees per year from becoming HBV carriers, thereby helping to halt the spread of this disease to the non-occupationally exposed population. Table VII-6 presents OSHA's estimates of the reductions in non-occupationally induced HBV infections due to the standard.
TABLE VII-6 - ANNUAL CASES-AVOIDED OF NONOCCUPATIONALLY - INDUCED HEPATITIS B CASES AVOIDED CASES AVOIDED TOTAL DUE BY CASES TO VACCINE SEX PARTNERS AVOIDED ______________________________________________________________________ HBV INFECTIONS 1,863 - 2,263 1,062 - 1,214 3,077 - 3,325 ACUTE SYMPTOMS 466 - 566 266 - 304 769 - 831 HOSPITALIZED 93 - 113 53 - 61 154 - 166 FULMINANT DEATH 2 - 3 1 - 2 4 - 4 HBV CARRIER 186 - 226 106 - 121 308 - 332 CRONIC HB 47 - 57 27 - 30 77 - 83 DEATH CIRRHOSIS 32 - 38 18 - 21 52 - 57 DEATH PHC 7 - 9 4 - 5 12 - 13 ALL DEATHS 41 - 50 24 - 27 68 - 74 ______________________________________________________________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Table VII-7 presents the total number of HBV infections estimated to be prevented by the standard, including 187 to 197 HBV related deaths annually.
TABLE VII-7 - ANNUAL NUMBER OF OCCUPATIONAL AND NONOCCUPATIONAL HEPATITIS B CASES AVOIDED TOTAL OCCUPATIONAL NONOCCUPATIONAL CASES CASES AVOIDED CASES AVOIDED AVOIDED ______________________________________________________________________ HBV INFECTIONS 5,058 - 5,781 3,325 - 3,077 8,383 - 8,858 ACUTE SYMPTOMS 1,265 - 1,445 831 - 769 2,096 - 2,215 HOSPITALIZED 253 - 289 166 - 154 419 - 443 FULMINANT DEATH 6 - 7 4 - 4 10 - 11 HBV CARRIER 253 - 578 332 - 308 585 - 886 CRONIC HB 63 - 145 83 - 77 146 - 221 DEATH CIRRHOSIS 86 - 98 57 - 52 143 - 151 DEATH PHC 20 - 23 13 - 12 34 - 35 ALL DEATHS 113 - 129 74 - 68 187 - 197 ______________________________________________________________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
D. Technological Feasibility
In this section, the provisions of the standard are examined with respect to their effectiveness in reducing the occupational risk faced by workers within the 16 industry sectors identified. Current compliance, or the level to which the requirements of the standard have already been implemented by employers, will also be discussed.
1. Effectiveness and Feasibility:
The requirement in the exposure control provision of the standard that employers document circumstances surrounding exposure incidents will contribute to overall risk reduction by increasing awareness of hazards. One witness reported that since emphasizing education, enforcement, and monitoring at her facility, reporting of exposure incidents has increased [Tr. 12/19/89, pp. 864-868]. Increased reporting of incidents, in turn, will allow safety and health practitioners to devise solutions to exposure hazards, once such hazards are identified [Tr. 12/19/89, p. 868; Ex. 20- 655, p. 2]. There are no technological barriers associated with this requirement.
The most effective method of preventing occupationally acquired HBV is the hepatitis B vaccine; evidence indicated that HBV vaccine will induce antibody in 85 to 98 percent of healthy young adults [Exs. 4-20; 6-45]. In testimony provided by a manufacturer of the vaccine, the immunogenicity rate for employees covered by the OSHA standard was estimated to be 96 percent [Ex. 292]. Thus, it is clear that employees can greatly reduce their risk of HBV infection by participating in a company-sponsored vaccine program.
The standard requires that all employees who are exposed to blood or other potentially infectious materials be offered the vaccine. To ensure that technological constraints would not preclude this provision of the standard from implementation, OSHA solicited comment on vaccine production capabilities [54 FR 23044]. Testimony presented by Merck, Sharp, and Dohme provided evidence that sufficient quantities of the vaccine could be produced and distributed [Tr. 9/18/89, pp. 90-104]; thus, OSHA determined the HBV vaccine provision of the standard to be technologically feasible.
The standard also provides for post-exposure prophylaxis against HBV. This prophylaxis consists of the hepatitis B immune globulin (HBIG) injection. This post-exposure treatment appears to be highly effective in preventing HBV infection when an exposed employee lacks anti-HBs [Ex. 6-45]. OSHA assumed that the production and distribution of additional quantities of HBIG would not pose a serious obstacle to the implementation of this requirement, since many facilities are already providing employees with this prophylaxis (Exs. 264, Q161; 266, Q138). The standard also requires employers to provide personal protective equipment (PPE) to all potentially exposed workers and to ensure its proper use. PPE includes gloves, coats or gowns, masks and eye protection (such as safety glasses or goggles), and face shields. These items serve as a barrier between the infectious material and the worker. Not all workers would be expected to require all items, however. Dentists will need eye and face protection when performing oral surgery or any other procedure which may result in the splattering or spraying of blood or saliva contaminated with blood, but this level of protection would seldom be necessary for a physician in an outpatient facility. Likewise, protective foot coverings may be required to reduce risk in a surgical or autopsy suite but would rarely be necessary for a nurse in a residential care facility. Used properly, PPE will reduce the risk of occupational exposure to bloodborne pathogens, as indicated by evidence in the record [Exs. 6-549, p. 1425; 237, p. 1; 260A (Lauer)].
Resuscitation equipment such as ambubags or pocket respirators are another type of PPE. These devices are most useful for emergency responders in reducing risk where the emergency situation requires resuscitation.
Potential limitations in implementing a PPE program include availability, interference with the performance of certain tasks, and physical variability of the workforce.
Commenters reported that certain types of gloves were in short supply [Exs. 11-73; 11-124]. However, this situation was reported to have improved [Tr. 9/19/89, p. 125]. Additionally, worker acceptance and compliance have also improved [Tr. 9/19/89, p. 120], and current rates of use are generally high (see Technical Appendix B); thus, incremental use attributable to the standard was not estimated to place significant demand on supplies. Commenters have also asserted that during certain procedures requiring manual dexterity, such as phlebotomy, glove use will not allow proper performance of tasks [Ex. 11-124]. However, data submitted into the record demonstrated that workers can be trained to perform tasks proficiently while using appropriate protective equipment [Exs. 230; 238]. The rule provides for training in and monitoring of proper work practices (this provision will be discussed more fully below) and all employers shall be expected to instruct workers in a manner that will increase their proficiency in performing all tasks using the appropriate precautions.
Some workers may be susceptible to dermatitis from frequent handwashing (handwashing is required by the standard whenever gloves are changed). Others may be allergic to certain types of gloves or the powder they contain [Ex. 13, p. II-27]. OSHA does not believe that the impact of the rule will be such that an excessive amount of additional handwashing will be required. Additionally, it is OSHA's understanding that alternatives to latex gloves are available [Exs. 20-647; 20-1320b; 20-390, p. 2]. Administrative controls, such as rotating employees, would also be useful when possible.
Communicating hazards to employees and providing training and information is paramount in the implementation of a standard such as this, since protective measures such as PPE and proper work practices will not be effective unless employees are instructed in their correct use. Training is also an important factor in risk reduction because not all employees are aware of the risks that they face in the workplace. Information programs can increase employee acceptance of HBV vaccine [Ex. 11-86, p. 15] and worker compliance with policies regarding personal protective equipment [Ex. 267C (Lynch)]. In one hospital, PPE usage increased from 50-75 percent to 95-98 percent when proper work practices were explained and enforced [Ex. 11-119]. Also, evidence indicated adherence to established work practice procedures could reduce needlestick exposures by as much as 40 percent [Ex. 6-160].
Estimates of the current level of compliance with this provision indicated that a substantial number of establishments are currently providing some level of training to their at-risk employees (see Technical Appendix C, Communication of Hazards). Most facilities, then, will only need to adjust their programs incrementally rather than to construct a training program from the ground up. No technological constraints were associated with such an adjustment.
Many feasible engineering controls are available to reduce risk of occupational exposure. The most ubiquitous engineering control required by the rule is the puncture-resistant sharps container. The purpose of the container is to eliminate the need for employees to transport needles and other sharps while looking for a place to dispose of them, and to support the prohibition against recapping, bending, breaking, or otherwise manipulating sharps by hand. Injuries also occur to housekeeping personnel when contaminated sharps are left on a bed, concealed in linen. Another device, which reportedly has the potential to eliminate needle-stick injuries associated with I.V. line junctions, is the needleless connector ["Estimated Cost of Needlestick Injuries for Six Major Needled Devices," Ex. 300, p. 11].
Other feasible engineering controls that can be used to meet requirements are mechanical pipetting devices, biosafety cabinets, and safety equipment for centrifuges. (Pipetting is a procedure by which fluid is drawn into a narrow tube by suction. The fluid may then be dispensed as needed.) These controls reduce risk by confining or isolating the infectious material from the worker. While these controls will typically be most appropriate for a laboratory environment, many types of establishments operate laboratories. For example, such controls might be necessary in a police lab or in a physician's office, as well as in a hospital.
Baseline information, where available, indicated that engineering controls were available or have already been introduced into the workplace in a number of establishments [Trs. 9/15/89, p. 160; 1/9/90, pp. 122-125; 1/11/90, p. 111; Exs. 20-961; 20-1290; 20-8; 264, Qs. 162, 187; 266, Q158].
It is clear that engineering controls, where appropriate, will reduce risk by confining or isolating infectious material. The equipment described is readily available and currently in use.
Work practice controls are extremely important in preventing occupational exposure. These types of controls will reduce risk by requiring employers to ensure that at-risk employees are performing their tasks in the safest manner possible, consistent with universal precautions. Examples of work practice controls are the forbidding of needle recapping when disposable needles are used, the forbidding of mouth-pipetting, and ensuring that hands are washed after removing personal protective equipment. The importance of strict adherence to work practice controls was reflected by evidence in the record [Exs. 237, p. 1; 260F (Beaumont)].
In any environment where engineering controls are available, workers must use such equipment properly. Thus, all training programs should provide at-risk workers with comprehensive instructions regarding the safest procedures for performing work tasks. As noted above, such training can be effective [Exs. 230; 238; 267C (Lynch)]; thus, OSHA finds that implementing safe work practices will not present significant difficulty for affected employers.
Finally, no technological obstacles exist with respect to the implementation of the housekeeping provision of the standard. Materials required, such as cleaning/disinfecting solutions and biowaste bags, are readily available.
In sum, OSHA has determined there will be no technological obstacles to implementing the standard.
2. Rates of Current Compliance
Current practices were examined to determine the extent to which measures have been implemented by affected establishments for the prevention of occupational exposure to bloodborne pathogens. Principal sources for this data were the OSHA 1989 multi-sector and hospital surveys and public comment.
Compliance rates for 19 sectors were generated from data collected during OSHA's multi-sector and hospital surveys following protocols detailed in Technical Appendix B to this analysis. Rates generated represented estimates of current compliance aggregated to the industry level. These rates were tabulated by provision and, where applicable, occupational categories for each of the 19 sectors surveyed. Exhibit B-3, Technical Appendix B, provides a tabulation of estimated compliance rates, by sector and provision. (Since no data were collected on the OSHA surveys with respect to current practices for PPE kits and resuscitation devices, current practice estimates for disposable glove use were used as a proxy in cost estimation formulas for kits, and resuscitation devices.) OSHA compared its survey-generated rates to similar data existing in the record. Where data were comparable, they supported OSHA's survey-generated compliance rates.
For example, in the dental sector, information on current practices with respect to use of PPE were provided by the Academy of General Dentists (AGD) and the ADA. The AGD testified that their 1987 survey found that more than 75 percent of its members were wearing gloves with all patients, and since that time "the dental profession has greatly stepped up its efforts" with respect to infection control [Tr. 9/22/89, p. 4-5]. The ADA submitted data which indicated similar trends. According to a 1988 survey performed by the ADA, the use of gloves with all patients varied from 76 percent for general practitioner dentists and assistants to 97 percent for hygienists, with use by general practitioner dentists increasing from 23 percent to 76 percent between 1986 and 1988 [Ex. 20-665N, IV.B.4]. The American Association of Orthodontics indicated that "recent" ADA studies show that 85 percent of dentists wear gloves [Tr. 10/17/89, p. 107-114]. Rates of mask use and gown use estimated by the ADA were lower than OSHA's estimated 47-58 percent and 15-20 percent, respectively.
Though the ADA argued that its 1988 survey was a "much more representative sample of the dentists in the U.S.," and suggested that current compliance estimates based on their 1988 survey are a more accurate representation of current practice in the dental sector, OSHA incorporated current practice estimates generated from the Agency's 1989 multi-sector survey into this analysis. OSHA judged the multi-sector estimates most representative for the following reasons.
First, both the AGD and ADA data represented periods of time approximately 2 years and 1 year, respectively, prior to the OSHA survey. Since information cited above clearly indicated improvements in current practices with respect to glove use, OSHA concluded that the ADA estimates understated current compliance. OSHA's estimates were based on the most recent data available.
Second, the ADA estimate for glove use covered dentists only. OSHA's estimate for health care workers included data for all dentists, hygienists, and assistants(6).
__________ Footnote(6) OSHA notes that estimated compliance rates for the occupational groups not included in the ADA estimate exceeded that of dentists. The American Board of Pediatrics indicated that compliance in the pediatric dental setting was about 90 percent (Tr., 10/19/89, p. 476), while ADA data indicated hygienists complied at a rate of 97 percent and maxillofacial surgeons complied at a greater rate than general practitioners (EX. 20-665N, IV.B.4).
Third, the ADA estimated the use of mask and gown protection for all patients, whereas under the regulation, use of these items would not be required for all patients. Thus, the ADA estimate of current practice with respect to the use of these items necessarily understated current practice in association with the requirements of the OSHA standard.
Additional multi-sector survey data were submitted by the American Federation of State, County, and Municipal Employees (AFSCME) [Ex. 297]. The survey was conducted after publication of the OSHA rulemaking and gathered data on PPE usage which indicated most facilities surveyed provided items in sufficient quantity, though not always in sufficient quality or size variations (questions 19-28). The data also indicated that employees did not use PPE in all recommended situations (question 29).
Survey results reported by AFSCME pertaining to source individual testing and counseling in hospitals were comparable to OSHA results. For example, AFSCME results indicated that hospitals attempted to test source individuals involved in an exposure incident to determine the presence of HIV or hepatitis infection 68 percent of the time. That is, 68 percent of all hospitals responding indicated that such testing was attempted. OSHA's calculations indicated that hospitals had policies consistent with such practice about 79 percent of the time with respect to hepatitis and 61 percent of the time with respect to HIV. AFSCME also reported that counseling was provided prior to HIV blood screening by 70 percent of all hospitals surveyed; OSHA's calculations indicated that hospitals had policies consistent with such practice about 72 percent of the time. AFSCME data on follow-up procedures reported for nursing homes/institutions for developmentally disabled indicated rates somewhat higher than those reported by OSHA. However, the AFSCME survey collected data pertaining to policies, while OSHA's multi-sector survey (which included nursing homes/institutions for developmentally disabled) collected data pertaining to actual practice. Consequently, the discrepancy between the AFSCME results and the OSHA results was most likely due to the failure of practice to equate to policy. The multi-sector survey presents the most accurate representation of actual practice in this area.
Other data examined included estimates of current practices with respect to the disposal of infectious waste in hospitals. One national study reported that over 95 percent of 441 American Hospital Association member hospitals surveyed segregated infectious waste from other waste and that over 96 percent of hospitals segregating used labels or color coded bags [Ex. 6-609]. These data supported estimates derived from OSHA's survey of hospitals. OSHA survey results indicated a 92 percent current compliance rate for infectious (regulated) waste disposal.
SEIU submitted data showing that slightly more than half of the occupations in its survey had received training [Ex. 20-979 (Table 4)]. The survey reported rates of current practice regarding training and workplace precautions: 58 percent for health professionals; 63 percent for other professionals; 49 percent for health technicians; 56 percent for nurse aides and other support personnel; 51 percent for maintenance workers and 39 percent for laundry workers. OSHA's current training estimates were generated for each of two separate requirements under the standard, turnover, or initial training (training required before a new employee begins work where occupational exposure is expected) and in-service training (training required at least annually to update previous training) and took into account both frequency and duration of training sessions. Since SEIU's estimates did not specify whether training was received prior to employment or during employment, and did not cover frequency or duration, they were of limited utility.
For sectors not surveyed, OSHA estimated levels of current practice solely from public comments and testimony. These estimated rates appear in Table VII-8, and are discussed below.
TABLE VII-8 - ESTIMATED RATES OF COMPLIANCE FOR NON-SURVEYED INDUSTRIES _____________________________________________________________________ Post-Exposure Industry PPE Follow-up Training Housekeeping _____________________________________________________________________ Linen Services 90% 90% 90% 90% Lifesaving 25% 50% 25% 50% Schools 25% 0% 0% N/A Waste removal 50% 50% 50% N/A _____________________________________________________________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
In the lifesaving sector, it was reported that training programs for lifeguards were inadequate with respect to information regarding bloodborne pathogens [Ex. 221, p. 4; Tr. 12/20/89, p. 1176]. However, some lifeguards are EMTs [Tr. 12/20/89, p. 1175], and may receive more comprehensive training. With regard to post-exposure follow-up, information provided by witnesses indicated that formal procedures were not in place, though access to follow-up was reportedly available [Tr. 12/20/89, pp. 1173, 1175, 1178]. Evidence also indicated that personal protective equipment may be provided, though this would not be considered typical [Tr. 12/20/89, p. 1181]. No information were provided regarding disposal procedures for contaminated sharps; therefore, OSHA assumed a 50 percent rate of current compliance for the housekeeping provision.
In the linen services sector, data indicated current compliance with personal protective equipment (PPE) and training requirements were high for one linen service company, Angelica Health Care Services, which reportedly followed universal precautions [Tr. 10/20/89, pp. 809-10, 817-818]. Since testimony by Mr. Steven Fellman, appearing for the Textile Rental Services Association (TRSA) and representing over 90 percent of the linen supply industry, indicated that Angelica was typical of TRSA's membership [Tr. 9/25/90, p. 74], OSHA estimated current compliance with PPE and training requirements to be high in this sector (90 percent). Also, since universal precautions were reportedly stressed, OSHA assumed that recommended housekeeping procedures are routinely followed, and that post-exposure follow-up is made available to any worker requesting treatment.
Information indicated that in schools, universal precautions are generally not practiced. For example, testimony presented by Ms. Barbara Brooks indicated the need for both training and post exposure follow-up programs at her place of employment [Tr. 1/12/90, pp. 485-487]. Similarly, testimony by Ms. Terry Nakatani also indicated the need for training, though PPE was apparently available [Tr. 1/12/90, pp. 487-492].
Finally, in the waste removal sector, data were limited regarding current practices. However, OSHA received comments from Browning-Ferris Industries (BFI), "the largest medical waste management company in North America engaged in the collection, transportation, and off-site treatment of medical waste" [Ex. 20-138, p. 1]. BFI reported that the company:
uses a variety of controls to prevent worker exposure to bloodborne pathogens and other infectious materials: training and education programs, medical surveillance programs that include pre-employment and annual physical exams, use of personal protective clothing and equipment, work practices, engineering controls, use of disinfectants, immunization programs, and post-exposure follow-up. [Ex. 20-138, p. 3]
BFI indicates that the hazards posed by blood and other potentially infectious materials have been recognized by the medical waste collection and disposal industry. This information is assumed to be representative of both public and private waste removal establishments. Based on this evidence, OSHA estimated current practice to represent approximately 50 percent of the cost of the standard's requirements for this sector.
Additional data regarding current practices were obtained from confidential surveys submitted by seven hospitals in response to question 163 [Ex. 266]. OSHA reviewed these data and produced the summary presented in Table VII-9. These data provided the Agency with information regarding worker compliance with hospital policy, and are addressed in more detail in Technical Appendix C (Compliance Cost Computations). Participating hospitals noted the difference between full compliance (percentage of affected population always performing in accordance with hospital policy) and partial compliance (measure of how often hospital policy is followed).
TABLE VII-9 - CURRENT COMPLIANCE DATA FOR SEVEN HOSPITALS WHICH SUPPLIED USEABLE RESULTS FROM IN-HOUSE SURVEYS
(For TABLE VII-9, Click Here)
E. Costs of Compliance
This section presents OSHA's final estimates of total net costs of compliance. Unless otherwise indicated, cost estimates presented represent the annualized, incremental costs associated with the standard. Calculations were based on data collected in two OSHA surveys and information submitted to the rulemaking docket.
In the discussion that follows, OSHA first presents a brief overview of estimation methods, followed by cost totals for each affected sector.
Incremental costs were first calculated for each respective provision of the standard, then aggregated to the industry level. Since many facilities were estimated to incur no cost (blood exposure was not reported on OSHA surveys), costs are associated only with those establishments affected by the rule. Costs were estimated in association with the following requirements of the standard: development of the exposure control plan; provision of hepatitis B vaccine and post-exposure follow-up at no cost to employees; provision of personal protective equipment; communication of hazards; housekeeping procedures; engineering and work practice controls; special precautions for research and production facilities; and recordkeeping.
For example, OSHA first estimated incremental compliance costs for the development of the exposure control plan, producing estimates for each affected sector. Other provisions were then addressed in turn, enabling total incremental costs for each affected sector to be calculated by summing the respective provisions.
To calculate estimates of incremental costs of compliance by provision, OSHA generally employed cost models developed in connection with its preliminary analysis [54 FR 23087-105]. In some cases, models were revised to reflect more recent information. Cost models used in this analysis are presented in Technical Appendix C.
Model inputs allowed cost calculations to reflect size and type of establishment, as well as occupational group (where applicable). For example, incremental costs were calculated for the development of the exposure control plan by using the following formulas:
Initial Costs (wage of infection control practitioner) x (time required) Recurring costs (wage of infection control practitioner) x (time required) Total Annual Costs (initial costs x amortization factor) + (recurring costs)
The general formulas developed and shown above for estimating costs were applicable to all establishments. Inputs such time requirements reflected variations between facility types, as well as current compliance.
In revising its preliminary models and cost estimates, OSHA relied principally on the Agency's multi-sector and hospital surveys, public comments to the record, and testimony presented at informal public hearings. These data allowed the Agency to refine preliminary estimates of unit costs, rates of use of personal protective equipment, and number of workers vaccinated against hepatitis B. (See Technical Appendix C for a complete discussion of data reviewed and revisions made).
In particular, with regard to estimates of the extent of current compliance, OSHA found that its surveys provided the best source of occupation-specific data. Technical Appendix B presents OSHA's methodology for calculating measures of current practice, or current compliance factors, as well as compliance profiles, from the survey data base.
As presented in Technical Appendix C, costs were generally estimated by performing calculations representing the full cost of compliance with the requirements of the standard reduced by a current compliance factor. The current compliance factor accounted for worker protection activities already taking place for which no additional expenditures would be required by an employer to comply with an OSHA rule.
Table VII-10 presents net annualized costs of compliance by major provision for each affected sector. As shown in the table, the greatest share of costs will be borne by hospitals, followed by physicians' offices, offices of dentists, and nursing homes. These four sectors represent approximately three-quarters of the total costs of compliance. These sectors include over 68 percent of the affected worker population and 47 percent of all affected establishments.
In general, incremental compliance costs for personal protective equipment and training were found to represent the greatest share of costs within each individual industry. Gloves and gowns were found to be high cost items in many sectors due to frequency of use, higher unit cost per use and low rates of current compliance. With regard to training, current practices were estimated to be inadequate for many establishments, resulting in costs which were a significant portion of overall costs.
Following is a sector by sector review of OSHA's estimated costs of compliance. Costs tabulated by provision are presented for each sector. For each sector, significant cost items are highlighted, and a brief discussion addressing factors affecting incremental compliance costs is presented. (Establishment counts and compliance rates were previously developed and/or described above in "Industry Profile" and "Technological Feasibility". Additional citations will not be presented here.)
TABLE VII-10 - SUMMARY OF COMPLIANCE COSTS - GRAND TOTALS
(For TABLE VII-10, Click Here)
Offices of Physicians.
Total annual incremental costs for the 122,104 physicians' offices affected by the standard were estimated to be $144 million. (Based on OSHA's multi-sector survey, 40,261 offices were estimated to incur no cost, since employees were not exposed to blood or other potentially infectious materials.) Table VII-11 presents costs for affected facilities by provision.
As shown in the table, personal protective equipment represented the largest cost of any major provision of the standard, nearly 50 percent ($68.6 million) of total costs and costs for gowns comprised well over one-half this total. This cost reflects the low level of current compliance for gown use of 43 percent. Compliance estimates indicated that in over 40 percent of all physicians' offices the level of current practice for gown use was 10 percent or below, while 38 percent of all offices were estimated to be at a level exceeding 90 percent, indicating that overall incremental costs for this PPE item will not be shared equally across all establishments in the sector. Current compliance for face protection was estimated to be lower than for gowns; however, unit costs for masks were considerably lower than unit costs for gowns and costs for face protection were estimated to be substantially less. Though compliance with glove use was significantly better, costs exceeded $17 million due to the high frequency of use of this item.
Costs for training also represented a significant portion of total costs (about 24 percent). Once again, estimates of current practice were quite low for this provision, indicating a lack of emphasis in this area.
TABLE VII-11 - OFFICES OF PHYSICIANS _____________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 1,154,198 5,680,278 6,834,476 55.97 Medical Provisions 2,602,896 12,167,194 14,770,091 120.96 HB Vaccination 2,602,896 1,867,862 4,470,759 36.61 Exposure Follow-up 0 10,299,332 10,299,332 84.35 Personal Protective Equipment 0 68,611,270 68,611,270 561.91 Gloves 0 17,159,437 17,159,437 140.53 Gowns 0 43,428,970 43,428,970 355.67 Masks 0 6,414,563 6,414,563 52.53 Goggles 0 1,318,547 1,318,547 10.80 Kits Respirators 0 289,753 289,753 2.37 Training 6,720,505 28,106,232 34,826,736 285.22 Housekeeping 372,455 6,796,992 7,169,447 58.72 Sharps Disposal 372,455 705,941 1,078,396 8.83 Biowaste Bags 716,594 716,594 5.87 Waste Hauling 5,374,456 5,374,456 44.02 Engineering/Work Practice Controls 8,985,997 8,985,997 73.59 Handwasing/ Glove Change 3,961,662 3,961,662 32.44 Safety Syringes 5,024,335 5,024,335 41.15 Recordkeeping 348,065 2,444,445 2,792,511 22.87 --------------------------------------------------------------------- TOTALS $11,198,120 $132,792,409 $143,990,528 $1,179.24 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Offices of Dentists.
Total annual incremental costs for the 100,174 dentists' offices affected by the standard were estimated to be $87.4 million. (Based on OSHA's multi-sector survey, 6,879 offices were estimated to incur no cost, since employees were not exposed to blood or other potentially infectious materials.) Table VII-12 presents costs for affected facilities by provision.
As shown in the table, personal protective equipment represented the largest cost of any major provision of the standard, representing over one-third of total costs ($30.4 million); costs for gowns comprised over one-half this total. This reflects the relatively low level of current compliance estimated for gown use (37 percent overall), coupled with this item's relatively high unit cost.
Costs for medical provisions, particularly post-exposure follow-up, represented just under 25 percent of overall compliance costs. The two factors responsible for the significant cost in this area were low current practice and the relatively high frequency of occurrence of exposure incidents.
TABLE VII-12 - OFFICES OF DENTISTS _____________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 932,019 4,660,094 5,592,113 55.82 Medical Provisions 1,070,521 20,494,597 21,565,118 215.28 HB Vaccination 1,070,521 182,241 1,252,762 12.51 Exposure Follow-up 0 20,312,356 20,312,356 202.77 Personal Protective Equipment 0 30,422,020 30,422,020 303.69 Gloves 0 9,384,935 9,384,935 93.69 Gowns 0 16,176,269 16,176,269 161.48 Masks 0 4,640,724 4,640,724 46.33 Goggles 0 220,092 220,092 2.20 Kits 0 0 0 0.00 Respirators 0 0 0 0.00 Training 3,209,257 10,907,755 14,117,012 140.92 Housekeeping(*) 887,605 4,955,585 5,843,189 58.33 Sharps Disposal 887,605 1,682,344 2,569,948 25.65 Biowaste Bags 32,146 32,146 0.32 Waste Hauling 241,095 241,095 2.41 Engineering/Work Practice Controls 5,433,408 5,433,408 54.34 Handwasing/ Glove Change 1,667,650 1,667,650 16.65 Safety Syringes 3,775,758 3,775,758 37.69 Recordkeeping 154,461 4,291,734 4,446,195 44.38 --------------------------------------------------------------------- TOTALS $6,253,863 $81,175,193 $87,429,055 $872.77 (*) Includes $3 million for surface coverings. ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for the approximately 12,200 nursing homes affected by the standard were estimated to be $69.8 million. Based on OSHA's multi-sector survey, about 770 homes were estimated to incur no cost, since employees were not exposed to blood or other potentially infectious materials.
Table VII-13 presents costs for affected facilities by provision. Incremental compliance costs associated with housekeeping and personal protective equipment contributed the greatest cost in this sector. Costs attributable to the disposal of regulated waste and gown use represented over one-half of total incremental costs. Costs for regulated waste disposal were significant due primarily to the volume of waste estimated to be generated (only 30 percent of all homes surveyed by OSHA reported an autoclave to be operated) [Ex. 264, Q193]. Gowns were a significant cost item due to frequency of use and high rate of non-compliance.
Compliance distributions indicated non-compliance to be somewhat concentrated for both provisions. With respect to waste removal, 18 percent of establishments surveyed indicated current practice to be no more than 10 percent, while 74 percent reported full compliance with the standard. With respect to gown use, 36 percent of establishments surveyed were at or below 10 percent compliant, while about 30 percent were reported in excess of 90 percent.
TABLE VII-13 - NURSING HOMES _____________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 454,035 567,544 1,021,579 83.74 Medical Provisions 1,713,621 6,481,516 8,195,138 671,73 HB Vaccination 1,713,621 4,049,626 5,763,247 472.40 Exposure Follow-up 0 2,431,890 2,431,890 199.34 Personal Protective Equipment 0 31,917,227 31,917,227 2,616.17 Gloves 0 5,355,432 5,355,432 438.97 Gowns 0 24,688,004 24,688,004 2,023.61 Masks 0 1,192,671 1,192,671 97.76 Goggles 0 432,972 432,972 35.49 Kits 0 0 0 0.00 Respirators 0 248,148 248,148 20.34 Training 816,920 4,889,364 5,706,284 467.73 Housekeeping 164,928 20,872,102 21,037,030 1,724.35 Sharps Disposal 164,928 312,601 477,529 39.14 Biowaste Bags 3,807,315 3,807,315 312.08 Waste Hauling 16,752,186 16,752,186 1,373.13 Engineering/Work Practice Controls 935,790 935,790 76.70 Handwasing/ Glove Change 460,137 460,137 37.72 Safety Syringes 475,654 475,654 38.99 Recordkeeping 248,222 718,395 966,616 79.23 --------------------------------------------------------------------- TOTALS $3,397,726 $66,381,937 $69,779,663 $5,719.64 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for the 6,197 hospitals affected by the standard were estimated to be $322 million. OSHA estimated between 800 and 900 hospitals to incur no cost, since these facilities were publicly administered in states without state occupational safety and health plans.
Table VII-14 presents costs for affected facilities by provision. The greatest cost impact will be due to increased glove usage. Costs for the purchase of additional gloves were estimated to be over one-fifth of total incremental costs. Engineering and work practice controls, which included costs associated with glove donning and doffing, handwashing, and the purchase of safety syringes, were also significant. Incremental housekeeping costs were related to the high volume of waste items (contaminated sharps and other regulated waste items) generated.
Current compliance in all areas was generally estimated to be high, with some problems identified with follow-up procedures and training. The compliance profile indicates general consistency across surveyed establishments.
TABLE VII-14 - HOSPITALS _____________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 461,255 1,153,138 1,614,393 260.51 Medical Provisions 9,845,664 16,899,740 26,745,404 4,315.86 HB Vaccination 9,845,664 13,821,630 23,667,294 3,819.15 Exposure Follow-up 0 3,078,110 3,078,110 496.71 Personal Protective Equipment 0 138,972,636 138,972,636 22,425.79 Gloves 0 67,850,128 67,850,128 10,948.87 Gowns 0 52,075,076 52,075,076 8,403.27 Masks 0 12,922,790 12,922,790 2,085.33 Goggles 0 1,923,075 1,923,075 310.32 Kits 0 0 0 0.00 Respirators 0 4,201,566 4,201,566 678.00 Training 4,347,497 21,426,338 25,773,835 4,159.08 Housekeeping 1,210,408 55,204,298 56,414,706 9,103.55 Sharps Disposal 1,210,408 7,568,579 8,778,986 1,416.65 Biowaste Bags 8,821,430 8,821,430 1,423.50 Waste Hauling 38,814,290 38,814,290 6,263.40 Engineering/Work Practice Controls 68,781,203 68,781,203 11,099.11 Handwasing/ Glove Change 28,513,097 28,513,097 4,601.11 Safety Syringes 40,268,106 40,268,106 6,498.00 Recordkeeping 1,340,609 2,270,912 3,611,521 582.79 --------------------------------------------------------------------- TOTALS $17,205,433 $304,708,264 $321,913,697 $51,946.70 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Medical and Dental Laboratories.
Total annual incremental costs for the 4,425 medical and dental laboratories affected by the standard were estimated to be $12.3 million. Based on OSHA's multi-sector survey, 3,346 laboratories were estimated to incur no cost, since employees were not exposed to blood or other potentially infectious materials.
Table VII-15 presents costs for affected facilities by provision. Personal protective equipment represented the largest share of total incremental compliance costs. Though OSHA's current practice estimates for this sector indicated high compliance for glove use relative to other provisions, glove use will command a significant share of overall costs due to frequent usage.
Costs for sharps disposal units were also estimated to be a significant percentage of overall costs, due to both a high rate of usage of disposable sharps and current practice levels (less than 60 percent of all labs had sharps disposal containers available at all points of sharps use).
OSHA compliance calculations also indicated training to be an area where improvement in current practice will be required to comply with the standard. Training represented a fairly high proportion of overall costs for labs.
TABLE VII-15 - MEDICAL AND DENTAL LABS _____________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 82,340 205,851 288,191 65.13 Medical Provisions 311,784 480,370 792,155 179.02 HB Vaccination 311,784 394,635 706,419 159.64 Exposure Follow-up 0 85,736 85,736 19.38 Personal Protective Equipment 0 4,559,722 4,559,722 1,030.45 Gloves 0 1,696,456 1,696,456 383.38 Gowns 0 1,929,829 1,929,829 436.12 Masks 0 841,843 841,843 190.25 Goggles 0 78,844 78,844 17.82 Kits 0 0 0 0.00 Respirators 0 12,751 12,751 2.88 Training 269,269 1,511,502 1,780,771 402.43 Housekeeping 679,505 2,855,174 3,534,580 798.80 Sharps Disposal 679,505 1,287,917 1,967,422 444.62 Biowaste Bags 237,463 237,463 53.66 Waste Hauling 1,329,794 1,329,794 300.52 Engineering/Work Practice Controls 1,242,593 1,242,593 280.81 Handwasing/ Glove Change 270,545 270,545 61.14 Safety Syringes 972,049 972,049 219.67 Recordkeeping 39,736 83,551 123,287 27.86 --------------------------------------------------------------------- TOTALS $1,382,635 $10,938,764 $12,321,399 $2,784.50 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Residential Care Facilities.
Total annual incremental costs for the 2,425 residential care establishments affected by the standard were estimated to be $4.4 million. Based on OSHA's multi-sector survey, 4,850 establishments were estimated to incur no cost, since employees were not exposed to blood or other potentially infectious materials. A large number of residential care facilities do not involve blood exposure, since residents in these establishments are generally more independent and self-sufficient than people in nursing homes. For this reason, employees are often involved in activities other than assisting with bodily functions. Residential care employees perform activities such as assisting the blind or deaf, running errands, etc.
Table VII-16 presents costs for affected facilities by provision. OSHA's calculations indicated most of the compliance costs in this sector to be fairly uniformly distributed among personal protective equipment, medical provisions, and training. Estimates of current practices were consistent across most areas of worker protection, though the level of effort associated with each particular provision will vary significantly among establishments. For example, with respect to regulated waste disposal, OSHA's compliance profile indicated that 46 percent of all affected establishments currently comply less than 10 percent of the time, while 51 percent of affected establishments reported full compliance.
TABLE VII-16 - RESIDENTIAL CARE ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 45,124 112,811 157,935 65.13 Medical Provisions 217,640 910,617 1,128,257 465.26 HB Vaccination 217,640 503,381 721,020 297.33 Exposure Follow-up 0 407,237 407,237 167.93 Personal Protective Equipment 0 905,583 905,583 373.44 Gloves 0 528,744 528,744 218.04 Gowns 0 305,832 305,832 126.12 Masks 0 15,258 15,258 6.29 Goggles 0 14,645 14,645 6.04 Kits 0 0 0 0.00 Respirators 0 41,104 41,104 16.95 Training 132,052 1,269,385 1,401,437 577.91 Housekeeping 3,551 536,351 539,902 222.64 Sharps Disposal 3,551 6,730 10,280 4.24 Biowaste Bags 62,308 62,308 25.69 Waste Hauling 467,313 467,313 192.71 Engineering/Work Practice Controls 81,202 81,202 33.49 Handwasing/ Glove Change 49,250 49,250 20.31 Safety Syringes 31,952 31,952 13.18 Recordkeeping 29,161 116,912 146,073 60.24 --------------------------------------------------------------------- TOTALS $427,528 $3,932,862 $4,360,390 $1,798.10 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Home Health Care.
Total annual incremental costs for the 6,437 home health establishments affected by the standard were estimated to be $11.4 million. Based on OSHA's multi-sector survey, about 15 percent of all home health establishments were estimated to incur no cost, since employees were not exposed to blood or other potentially infectious materials. Including establishments operating in states without state occupational safety and health plans, OSHA estimated 1,623 establishments to be unaffected by the standard and to incur no compliance costs.
Table VII-17 presents costs for affected facilities by provision. Costs for training and the hepatitis B vaccination were identified as the most significant areas of cost in this sector. The relatively high costs associated with these provisions are explained by the large number of affected employees (212,246). Employees in this sector will also be required to comply with the housekeeping provisions of the standard, including procedures for sharps disposal, the use of biowaste bags, and procedures for waste hauling. The annual costs for these provisions are $100,412, $19,079 and $106,844, respectively. Costs for housekeeping, follow-up, engineering and work practice controls, and personal protective equipment are less significant for this sector because exposure to potentially infectious fluids would occur relatively less frequently than in other sectors.
OSHA's compliance profile indicated that current practices associated with training and vaccination programs varied significantly among establishments.
TABLE VII-17 - HOME HEALTH ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 119,780 299,449 419,229 65.13 Medical Provisions 859,074 2,228,055 3,087,128 479.59 HB Vaccination 859,074 1,900,096 2,759,170 428.64 Exposure Follow-up 0 327,958 327,958 50.95 Personal Protective Equipment 0 2,360,670 2,360,670 366.73 Gloves 0 948,979 948,979 147.43 Gowns 0 559,979 559,979 86.99 Masks 0 186,547 186,547 28.98 Goggles 0 145,623 145,623 22.62 Kits 0 0 0 0.00 Respirators 0 519,542 519,542 80.71 Training 385,726 4,303,705 4,689,431 728.51 Housekeeping 34,680 191,655 266,335 35.16 Sharps Disposal 34,680 65,732 100,412 15.60 Biowaste Bags 19,079 19,079 2.96 Waste Hauling 106,844 106,844 16.60 Engineering/Work Practice Controls 388,799 388,799 60.40 Handwasing/ Glove Change 83,608 83,608 12.99 Safety Syringes 305,191 305,191 47.41 Recordkeeping 118,751 159,229 277,980 43.18 --------------------------------------------------------------------- TOTALS $1,518,010 $9,931,563 $11,449,573 $1,778.71 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for the 651 hospice establishments affected by the standard were estimated to be $593,588. Based on OSHA's multi-sector survey, 290 hospices were estimated to incur no cost, since employees were not exposed to blood or other potentially infectious materials.
Table VII-18 presents costs for affected facilities by provision. Similar to the situation described above for home health establishments, the most costly provisions of the standard were costs associated with employment levels, namely training and the hepatitis B vaccination.
OSHA's compliance profile indicated a broad range of activity with respect to current practice in connection with worker training; however, more than one-quarter of all establishments were estimated to be at 10 percent or lower compliance. OSHA's data also indicated most facilities were not offering the hepatitis B vaccine free of charge to all exposed employees.
TABLE VII-18 - HOSPICE CARE ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 12,114 30,285 42,398 65.13 Medical Provisions 50,570 146,144 196,713 302.17 HB Vaccination 50,570 113,272 163,842 251.68 Exposure Follow-up 0 32,871 32,871 50.49 Personal Protective Equipment 0 104,442 104,442 160.43 Gloves 0 29,727 29,727 45.66 Gowns 0 20,719 20,719 31.83 Masks 0 7,270 7,270 11.17 Goggles 0 17,717 17,717 27.21 Kits 0 0 0 0.00 Respirators 0 29,009 29,009 44.56 Training 26,732 170,194 196,925 302.50 Housekeeping 66 22,117 22,183 34.08 Sharps Disposal 66 125 192 0.29 Biowaste Bags 3,332 3,332 5.12 Waste Hauling 18,659 18,659 28.66 Engineering/Work Practice Controls 9,978 9,978 15.33 Handwasing/ Glove Change 2,525 2,525 3.88 Safety Syringes 7,453 7,453 11.45 Recordkeeping 6,687 14,262 20,948 32.18 --------------------------------------------------------------------- TOTALS $96,168 $497,420 $593,588 $911.81 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for the 782 freestanding dialysis establishments affected by the standard were estimated to be $2.3 million. Based on OSHA's multi-sector survey, all establishments were affected, since employees were reported to be exposed to blood or other potentially infectious materials in each establishment surveyed.
Table VII-19 presents costs for affected facilities by provision. Costs for personal protective equipment were estimated to be most significant for this sector, particularly for use of gowns, where current practice was estimated to be relatively low. Incremental training costs were estimated to be the next largest category of compliance costs.
Compliance profiles indicated a substantial number of establishments to have achieved full compliance with regard to gown usage (40 percent of establishments surveyed) and in-service training (50 percent of establishments surveyed). At the same time, however, over one-quarter of establishments surveyed reported a baseline position of only 0-10 percent with regard to gown usage; 20 percent of establishments reported in-service training falling within this lowest range.
TABLE VII-19 - HEMODIALYSIS ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 14,551 36,379 50,930 65.13 Medical Provisions 44,348 197,320 241,668 309.04 HB Vaccination 44,348 68,488 112,836 144.29 Exposure Follow-up 0 128,831 128,831 164.75 Personal Protective Equipment 0 1,320,193 1,320,193 1,688.23 Gloves 0 207.340 207.340 265.14 Gowns 0 910,787 910,787 1,164.69 Masks 0 186,279 186,279 238.21 Goggles 0 15,389 15,389 19.68 Kits 0 0 0 0.00 Respirators 0 398 398 0.51 Training 41,447 260,607 302,054 386.26 Housekeeping 3,189 39,168 42,356 54.16 Sharps Disposal 3,189 6,044 9,233 11.81 Biowaste Bags 5,019 5,019 6.42 Waste Hauling 28,105 28,105 35.94 Engineering/Work Practice Controls 271,929 271,929 347.74 Handwasing/ Glove Change 31,399 31,399 40.15 Safety Syringes 240,531 240,531 307.58 Recordkeeping 6,354 71,480 77,834 99.53 --------------------------------------------------------------------- TOTALS $109,890 $2,197,074 $2,306,964 $2,950.08 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for the 744 drug rehabilitation centers affected by the standard were estimated to be $413,514. Based on OSHA's multi-sector survey, 3,162 centers were estimated to incur no cost, since employees were not reported to be exposed to blood or other potentially infectious materials.
Table VII-20 presents costs for affected facilities by provision. Training accounted for almost one-half of overall compliance costs. Providing employees with the hepatitis B vaccination will also require expenditures under the standard. OSHA's compliance profile for this sector indicated the majority of facilities will incur significant to moderate costs to bring training programs into compliance. In contrast, over one-third of affected establishments were estimated to already offer the hepatitis B vaccine to all or most exposed employees at no charge.
TABLE VII-20 - DRUG REHABILITATION ______________________________________________________________________
- Total Annual Annualized Recurring Annual Cost
per Standard Provision First-year Cost Cost Facility
Exposure Control Plan 13,844 34,611 48,455 65.13
Medical Provisions 25,353 46,457 71,810 96.52
- HB Vaccination 25,353 39,020 64,373 86.52
Exposure Follow-up 0 7,437 7,437 10.00
- Equipment 0 68,171 68,171 91.63
- Gloves 0 35,082 35,082 47.15
Gowns 0 19,671 19,671 26.44 Masks
0 4,809 4,809 6.46 Goggles
0 7,095 7,095 9.54 Kits
0 0 0 0.00 Respirators 0
1,513 1,513 2.03
Training 31,354 165,397 196,751 264.45
Housekeeping 69 9,691 9,760 13.12
- Sharps Disposal 69 131 200 0.27
Biowaste Bags 1,448 1,448 1.95 Waste
Hauling 8,111 8,111 10.90
- Practice Controls 10,409 10,409 13.99
Handwasing/ Glove Change 4,624 4,624 6.21 Safety Syringes 5,785 5,785 7.78
Recordkeeping 3,535 4,622 8,157 10.96
TOTALS $74,156 $339,358 $413,514 $555.80
Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Government Outpatient Clinics.
Total annual incremental costs for the 10,893 public clinics affected by the standard were estimated to be $10.7 million. OSHA estimated an equal number of establishments to be administered in states without state occupational safety and health plans. Such establishments would not be affected by the standard, and will incur no costs in association with the rule.
Table VII-21 presents costs for affected facilities by provision. Costs were estimated to be most significant in the areas of personal protective equipment and training. (Since government clinics were not surveyed, rates of equipment usage and estimates of current practice used in performing the calculations for physicians' offices were used in computing cost estimates for clinics.) As explained above for physicians' offices, rates of compliance for gowns were found to be low, as were rates of compliance for training. Glove use was a significant cost item due to frequency of use.
TABLE VII-21 - GOVERNMENT OUTPATIENT CLINICS ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 202,697 506,742 709,439 65.13 Medical Provisions 228,791 1,222,996 1,451,787 133.28 HB Vaccination 228,791 307,713 536,504 49.25 Exposure Follow-up 0 915.283 915.283 84.02 Personal Protective Equipment 0 3,893,082 3,893,082 357.39 Gloves 0 1,507,078 1,507,078 138.35 Gowns 0 1,699,008 1,699,008 155.97 Masks 0 563,355 563,355 51.72 Goggles 0 97,792 97,792 8.98 Kits 0 0 0 0.00 Respirators 0 25,849 25,849 2.37 Training 594,322 2,453,354 3,047,676 279.78 Housekeeping 32,711 483,923 516,634 47.43 Sharps Disposal 32,711 61,999 94,709 8.69 Biowaste Bags 63,928 63,928 5.87 Waste Hauling 357,997 357,997 32.86 Engineering/Work Practice Controls 790,219 790,219 72.54 Handwasing/ Glove Change 341,994 341,994 31.40 Safety Syringes 448,225 448,225 41.15 Recordkeeping 30,605 217,969 248,574 22.82 --------------------------------------------------------------------- TOTALS $1,089,126 $9,568,286 $10,657,412 $978.37 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for the 730 affected establishments identified were estimated to be $4 million. OSHA judged all establishments to be affected, since employees were reported to be exposed to blood or other potentially infectious materials in 99 percent of establishments surveyed.
Table VII-22 presents costs for affected facilities by provision. As shown, personal protective equipment and engineering and work practice controls account for almost 80 percent of the total annual cost for this sector. OSHA believes the cost for glove use would be significantly higher if the standard required mandatory glove use for phlebotomists. Average overall cost per affected establishment was estimated to be $5,496.
TABLE VII-22 - BLOOD/PLASMA/TISSUE CENTERS ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 13,584 33,960 47,543 65.13 Medical Provisions 63,561 235,716 299,277 409.97 HB Vaccination 63,561 82,908 146,469 200.64 Exposure Follow-up 0 152,808 152,808 209.33 Personal Protective Equipment 0 1,949,073 1,949,073 2,669.96 Gloves 0 556,902 556,902 762.88 Gowns 0 866,114 866,114 1,186.46 Masks 0 488,347 488,347 688.97 Goggles 0 35,977 35,977 49.28 Kits 0 0 0 0.00 Respirators 0 1,732 1,732 2.37 Training 49,207 282,189 331,395 453.97 Housekeeping 2,469 87,964 90,434 123.88 Sharps Disposal 2,469 4,680 7,149 9.79 Biowaste Bags 12,619 12,619 17.29 Waste Hauling 70,666 70,666 96.80 Engineering/Work Practice Controls(*) 1,193,678 1,193,678 1,635.18 Handwasing/ Glove Change 74,073 74,073 101.47 Safety Syringes 293,285 293,285 401.76 Recordkeeping 9,266 91,512 100,778 138.05 --------------------------------------------------------------------- TOTALS $138,086 $3,874,092 $4,012,178 $5,496.13 * Includes $826,320 for leakprrof containers. ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for the 1,348 personnel service establishments affected by the standard were estimated to be $13.3 million. Based on OSHA's multi-sector survey, 3,847 establishments were estimated to incur no cost, since employees were not reported to be exposed to blood or other potentially infectious materials.
Table VII-23 presents costs for affected facilities by provision. Personal protective equipment, particularly gowns, will be the most significant cost item for these establishments(7). Training will also be needed, due to the high number of affected employees (over 163,000), high turnover, and poor baseline profile.
__________ Footnote(7) OSHA notes that compliance with personal protective equipment provisions for temporary service workers was assumed to be zero (no useable survey data were received for this worker category).
TABLE VII-23 - PERSONNEL SERVICES ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 50,167 62,709 112,876 83.74 Medical Provisions 797,004 817,017 1,614,021 1,197.34 HB Vaccination 797,004 745,830 1,542,834 1,144.54 Exposure Follow-up 0 71,187 71,187 52.81 Personal Protective Equipment 0 8,068,434 8,068,434 5,985.49 Gloves 0 1,060,494 1,060,494 786.72 Gowns 0 5,549,215 5,549,215 4,116.63 Masks 0 1,165,084 1,165,084 864.31 Goggles 0 283,819 283,819 210.55 Kits 0 0 0 0.00 Respirators 0 9,822 9,822 7.29 Training 264,670 3,100,654 3,365,324 2,496.53 Housekeeping 0 0 0 0.00 Sharps Disposal 0 0 0 0.00 Biowaste Bags 0 0 0 0.00 Waste Hauling 0 0 0 0.00 Engineering/Work Practice Controls 11,926 11,926 8.85 Handwasing/ Glove Change 11,926 11,926 8.85 Safety Syringes 0 0 0 0.00 Recordkeeping 87,668 88,496 176,165 130.69 --------------------------------------------------------------------- TOTALS $1,199,509 $12,149,237 $13,348,746 $9,902.63 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for the 19,890 funeral homes and crematories affected by the standard were estimated to be $8.8 million. OSHA estimated 1,046 establishments to incur no cost; OSHA's survey indicated that in 5 percent of establishments surveyed, employees were not exposed to blood or other potentially infectious materials.
Table VII-24 presents costs for affected facilities by provision. Major areas of expenditure for establishments in this sector include personal protective equipment and training, which together account for over 60 percent of overall compliance costs.
OSHA's compliance profile indicated that in each of the three major areas of personal protective equipment (gloves, gowns, face protection), a majority of establishments were currently complying at a rate exceeding 90 percent. With regard to training, however, low current practice (0 to 10 percent) was indicated for most establishments. These figures suggest that for this sector, the level of effort required to bring establishments into compliance with the standard will not vary widely among affected entities.
TABLE VII-24 - FUNERAL SERVICES ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 185,057 925,283 1,110,339 55.82 Medical Provisions 319,661 1,183,720 1,503,382 75.58 HB Vaccination 319,661 403,430 723,091 36.35 Exposure Follow-up 0 780,291 780.291 39.23 Personal Protective Equipment 0 2,423,908 2,432,908 121.87 Gloves 0 545,032 545,032 27.40 Gowns 0 1,361,826 1,361,826 68.47 Masks 0 459,079 459,079 23.08 Goggles 0 57,972 57,972 2.91 Kits 0 0 0 0.00 Respirators 0 0 0 0.00 Training 760,566 2,220,828 2,981,395 149.89 Housekeeping 1,203 578,115 579,318 29.13 Sharps Disposal 1,203 2,280 3,483 0.18 Biowaste Bags 67,745 67,745 4.41 Waste Hauling 508,089 508,089 25.54 Engineering/Work Practice Controls 50,208 50,208 2.52 Handwasing/ Glove Change 39,467 39,467 1.98 Safety Syringes 10,741 10,741 0.54 Recordkeeping 32,560 162,039 194,599 9.78 --------------------------------------------------------------------- TOTALS $1,299,047 $7,544,102 $8,843,149 $444.60 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Health Units in Industry.
Total annual incremental costs for the 202,540 industrial establishments affected by the standard were estimated to be $67.9 million.
Table VII-25 presents costs for affected facilities by provision. Training will require additional resources to comply with the standard. Costs for development of the infection control program and costs associated with exposure follow-up will also comprise a large percentage of overall compliance costs. Average costs for establishments in this sector were estimated to be relatively low ($334).
OSHA's compliance profile indicated low current practice with respect to training. Current compliance with follow-up procedures, gown use, and use of face protection were also areas where improvement by a majority of establishments would be needed, while compliance with glove use was already high.
TABLE VII-25 - HEALTH UNITS IN INDUSTRY ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 3,778,931 9,447,328 13,226,259 65.13 Medical Provisions 825,705 14,214,074 15,039,779 74.06 HB Vaccination 825,705 1,178,909 2,004,614 9.87 Exposure Follow-up 0 13,035,165 13,035,165 64.19 Personal Protective Equipment 0 5,265,303 5,265,303 25.93 Gloves 0 2,842,622 2,842,622 14.00 Gowns 0 1,349,418 1,349,418 6.64 Masks 0 261,916 261,916 1.29 Goggles 0 260,592 260,592 1.28 Kits 0 0 0 0.00 Respirators 0 550,756 550,756 2.71 Training 8,546,094 14,730,391 23,276,485 114.62 Housekeeping 9,387 4,794,294 4,803,681 23.65 Sharps Disposal 9,387 17,791 27,178 0.13 Biowaste Bags 561,942 561,942 2.77 Waste Hauling 4,214,561 4,214,561 20.75 Engineering/Work Practice Controls 3,719,231 3,719,231 18.31 Handwasing/ Glove Change 188,058 188,058 0.93 Safety Syringes 3,531,172 3,531,172 17.39 Recordkeeping 90,039 2,483,549 2,573,588 12.67 --------------------------------------------------------------------- TOTALS $13,250,156 $54,654,170 $67,904,326 $334.37 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for the 1,453 research and production laboratories affected by the standard were estimated to be $6.3 million. Based on its survey, OSHA estimated 1,372 commercial, noncommercial, and pharmaceutical establishments to incur no cost, as employees were not reported to be exposed to blood or other potentially infectious materials. OSHA also estimated about 800 publicly administered establishments would incur no cost, since these establishments were located in states without state occupational safety and health plans.
Table VII-26 presents costs for affected facilities by provision. The great majority of costs were estimated to be fairly evenly distributed among three cost areas: the hepatitis B vaccine, personal protective equipment, and training.
OSHA's compliance profile indicated that labs were generally meeting glove and gown requirements consistently, while face protection and vaccine requirements were essentially not being met by many affected establishments. Most labs will require significant to moderate improvement in bringing training programs into compliance.
TABLE VII-26 - RESEARCH/PRODUCTION FACILITIES ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 27,037 67,594 94,631 65.13 Medical Provisions 556,449 734,352 1,290,801 888.37 HB Vaccination 556,449 716,123 1,272,572 875.82 Exposure Follow-up 0 18,229 18,229 12.55 Personal Protective Equipment 0 2,751,244 2,751,244 1,893.49 Gloves 0 771,114 771,114 530.70 Gowns 0 1,392,135 1,392,135 958.11 Masks 0 520,588 520,588 358.28 Goggles 0 67,407 67,407 46.39 Kits 0 0 0 0.00 Respirators 0 0 0 0.00 Training 194,347 1,666,099 1,860,446 1,280.42 Housekeeping 39,194 63,303 102,497 70.54 Sharps Disposal 39,194 63,303 102,497 70.54 Biowaste Bags 0 0 0.00 Waste Hauling 0 0 0.00 Engineering/Work Practice Controls 150,111 150,111 103.31 Handwasing/ Glove Change 99,267 99,267 68.32 Safety Syringes 50,843 50,843 34.99 Recordkeeping 54,684 18,493 73,178 50.36 --------------------------------------------------------------------- TOTALS $871,712 $5,451,196 $6,322,908 $4,351.62 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for the 1,250 linen service establishments affected by the standard were estimated to be $1.9 million. Data indicated an equal number of establishments to incur no cost, due to the absence of worker exposure.
Table VII-27 presents costs for affected facilities by provision. As shown, costs associated with personal protective equipment will be most significant.
Though OSHA did not survey linen service establishments, information in the record indicated compliance is high in all areas. OSHA assumed that most facilities would incur about $1,554 in additional costs due to the standard.
TABLE VII-27 - LINEN SERVICES ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 23,260 58,150 81,410 65.13 Medical Provisions 188,393 205,929 394,322 315.46 HB Vaccination 188,393 183,683 372,075 297.66 Exposure Follow-up 0 22,246 22,246 17.80 Personal Protective Equipment 0 1,088,948 1,088,948 871.16 Gloves 0 109,710 109,710 87.77 Gowns 0 750,375 750,375 600.30 Masks 0 225,113 225,113 180.09 Goggles 0 3,750 3,750 3.00 Kits 0 0 0 0.00 Respirators 0 0 0 0.00 Training 52,409 215,754 268,162 214.53 Housekeeping 0 33,150 33,150 26.52 Sharps Disposal 0 0 0 0.00 Biowaste Bags 3,900 3,900 3.12 Waste Hauling 29,250 29,250 23.40 Engineering/Work Practice Controls 924 924 0.74 Handwasing/ Glove Change 924 924 0.74 Safety Syringes 0 0 0 0.00 Recordkeeping 23,048 51,976 75,024 60.02 --------------------------------------------------------------------- TOTALS $287,109 $1,654,830 $1,941,939 $1,553.55 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Medical Equipment Repair.
Total annual incremental costs for the 1,076 medical equipment repair establishments affected by the standard were estimated to be $6 million. OSHA estimated 2,184 establishments will incur no cost, as employees are not exposed to blood or other potentially infectious materials during routine performance of duties.
Table VII-28 presents costs for affected facilities by provision. OSHA identified personal protective equipment as the most significant cost area for these establishments. Due to the volume of repairs performed and a low rate of current compliance, costs for the use of protective gowns were estimated to comprise over one-third of overall compliance costs. Costs for glove use were also significant, though current practice estimates for this item were much higher. Costs for sharps disposal units were estimated to be about 10 percent of overall costs, due largely to the fact that only about 17 percent of establishments surveyed indicated that sharps disposal containers were available at all points of sharps use.
Compliance profile data indicated divergence in current practices. For example, 63 percent of all establishments surveyed were at a level of compliance of 80 percent or better with regard to glove use, while 14 percent were at a level of compliance of 20 percent or lower. In contrast, 93 percent of establishments surveyed were at a level of compliance of 10 percent or lower with regard to gown use. While many establishments will require additional expenditures for gloves and gowns, the level of effort required to achieve compliance will not be consistent across the industry.
TABLE VII-28 - MEDICAL EQUIPMENT REPAIR ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 20,022 50,056 70,078 65.13 Medical Provisions 30,283 245,845 276,128 256.62 HB Vaccination 30,283 41,897 72,180 67.08 Exposure Follow-up 0 203,948 203,948 189.54 Personal Protective Equipment 0 4,543,377 4,543,377 4,222.47 Gloves 0 1,897,400 1,897,400 1,763.38 Gowns 0 2,260,020 2,260,020 2,100.39 Masks 0 382,352 382,352 355.35 Goggles 0 3,605 3,605 3.35 Kits 0 0 0 0.00 Respirators 0 0 0 0.00 Training 62,106 191,398 253,503 235.60 Housekeeping 213,611 404,874 618,485 574.80 Sharps Disposal 213,611 404,874 618,485 574.80 Biowaste Bags 0 0 0.00 Waste Hauling 0 0 0.00 Engineering/Work Practice Controls 213,104 213,104 198.05 Handwasing/ Glove Change 213,104 213,104 198.05 Safety Syringes 0 0 0.00 Recordkeeping 3,233 35,348 38,581 35.86 --------------------------------------------------------------------- TOTALS $329,255 $5,684,001 $6,013,256 $5,588.53 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for the 4,946 law enforcement departments affected by the standard were estimated to be $10.9 million. OSHA estimated a similar number of departments to incur no cost, as employees were located in states without state occupational safety and health plans.
Table VII-29 presents costs for affected facilities by provision. Costs associated with training and personal protective equipment, including PPE "kits," represented almost 70 percent of overall compliance costs. Vaccination costs were also significant.
The large size of the affected workforce, 341,546 employees, explains the magnitude of industry wide cost for this sector. Cost per department was estimated to average about $2,194.
OSHA's compliance profile indicated about 34 percent of departments surveyed offered hepatitis B vaccine to all exposed workers free of charge. Most other departments will incur costs in this area. Current training practices were estimated to vary widely, though most departments will also require substantial improvement with respect to this provision. With regard to personal protective equipment, current compliance with gown and face protection requirements were estimated to be very low for most departments.
TABLE VII-29 - LAW ENFORCEMENT ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 92,035 230,088 322,123 65.13 Medical Provisions 1,133,375 1,104,053 2,237,428 452.37 HB Vaccination 1,133,375 883,466 2,016,841 407.77 Exposure Follow-up 0 220,588 220,588 44.60 Personal Protective Equipment 0 3,311,809 3,311,809 669.59 Gloves 0 13,363 13,363 2.70 Gowns 0 1,717,598 1,717,598 347.27 Masks 0 100,455 100,455 20.31 Goggles 0 197,910 197,910 40.01 Kits 0 1,282,484 1,282,484 259.30 Respirators 0 0 0 0.00 Training 659,794 3,529,405 4,189,199 846.99 Housekeeping 10,867 41,478 52,344 10.58 Sharps Disposal 10,867 17,552 28,419 5.75 Biowaste Bags 23,926 23,926 4.84 Waste Hauling 0 0 0.00 Engineering/Work Practice Controls 195,410 195,410 39.51 Handwasing/ Glove Change 7,917 7,917 1.60 Safety Syringes 187,493 187,493 37.91 Recordkeeping 167,136 378,461 545,597 110.31 --------------------------------------------------------------------- TOTALS $2,063,208 $8,790,703 $10,853,911 $2,194.48 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Fire and Rescue.
Total annual incremental costs for the 3,174 fire and rescue establishments affected by the standard were estimated to be $15 million. OSHA estimated a similar number of departments to incur no cost, as employees were located in states without state occupational safety and health plans.
Table VII-30 presents costs for affected facilities by provision. Due to the frequency and severity of emergency situations encountered, personal protective equipment was estimated to be the most significant cost area for this sector. The large number of affected employees identified, over 252,000, also resulted in estimates of significant incremental costs for training and hepatitis B vaccination.
Estimates of current practice for this sector indicated high compliance for EMTs with regard to glove use, though considerable effort will be required by all occupational categories to achieve compliance with gown and face protection provisions. Also, OSHA's compliance profile indicated most establishments to be either complying at rates over 90 percent or under 10 percent with respect to glove use, use of face protection, provision of the vaccine, and training. Since most compliance costs were estimated to be associated with these items, certain departments may experience costs varying considerably above or below the average for these provisions.
TABLE VII-30 - FIRE AND RESCUE ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 59,062 147,654 206,716 65.13 Medical Provisions 1,206,997 1,501,566 2,708,562 853.36 HB Vaccination 1,206,997 1,187,823 2,394,820 754.51 Exposure Follow-up 0 313,743 313,743 98.85 Personal Protective Equipment 0 9,573,585 9,573,585 3,016.25 Gloves 0 1,497,481 1,497,481 471.80 Gowns 0 5,924,957 5,924,957 1,866.72 Masks 0 1,084,507 1,084,507 341.68 Goggles 0 217,141 217,141 68.41 Kits 0 0 0 0.00 Respirators 0 849,498 849,498 267.64 Training 214,007 1,695,580 1,909,586 601.63 Housekeeping 3,493 70,368 73,862 23.27 Sharps Disposal 3,493 6,621 10,115 3.19 Biowaste Bags 63,747 63,747 20.18 Waste Hauling 0 0 0.00 Engineering/Work Practice Controls 216,141 216,141 68.10 Handwasing/ Glove Change 183,233 183,233 57.73 Safety Syringes 32,908 32,908 10.37 Recordkeeping 130,186 195,299 325,485 102.55 --------------------------------------------------------------------- TOTALS $1,613,744 $13,400,192 $15,013,937 $4,730.29 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for the 1,895 correctional facilities affected by the standard were estimated to be $4.9 million. Approximately 900 additional facilities were estimated to incur no cost, as employees were located in states without state occupational safety and health plans.
Table VII-31 presents costs for affected facilities by provision. OSHA estimated costs for personal protective equipment to be most significant, followed by training and medical provisions costs. Costs for gloves and PPE "kits" accounted for over one-half incremental costs for personal protective equipment. ("Kits" contain a complete set of disposable items, including gloves, gown, and face mask, and were estimated to be used by the largest occupational category, correctional officers.) As indicated for many sectors, current practice with regard to glove use was found to be much closer to the requirements under the standard than current practice with regard to other items of personal protective equipment and training. Compliance profiles suggest most facilities will require considerable improvement in both in-service and turnover training, with very few facilities in full compliance with the standard. Compliance with regard to personal protective equipment was found to be more widely varying, with many facilities complying at rates better than 90 percent. Compliance with respect to follow-up procedures was generally high.
TABLE VII-31 - CORRECTIONAL FACILITIES ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 32,825 82,061 114,886 65.13 Medical Provisions 471,313 851,077 1,322,391 749.65 HB Vaccination 471,313 499,526 970,839 550,36 Exposure Follow-up 0 351,551 351,551 896.32 Personal Protective Equipment 0 1,581,115 1,581,115 896.32 Gloves 0 520,441 520,441 295.03 Gowns 0 439,421 439,421 249.10 Masks 0 127,375 127,375 72.21 Goggles 0 91,805 91,805 52.04 Kits 0 399,681 399,681 226.58 Respirators 0 2,392 2,392 1.36 Training 194,999 1,243,952 1,438,951 815.73 Housekeeping 2,503 151,475 153,978 87.29 Sharps Disposal 2,503 4,043 6,546 3.71 Biowaste Bags 17,345 17,345 9.83 Waste Hauling 130,087 130,087 73.75 Engineering/Work Practice Controls 93,437 93,437 52.97 Handwasing/ Glove Change 9,422 9,422 5.34 Safety Syringes 84,016 84,016 47.63 Recordkeeping 65,714 145,563 211,278 119.77 --------------------------------------------------------------------- TOTALS $767,354 $4,148,681 $4,916,036 $2,786.87 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for the estimated 100 emergency rescue departments affected by the standard were estimated to be $473,872. Locations where departments would be affected by the standard include beach rescue services in states with state occupational safety and health plans, such as California, South Carolina, North Carolina, Virginia, Maryland, Connecticut, New York, and Hawaii. OSHA estimated an equivalent number of departments in Florida, Georgia, New Jersey, or other states without state occupational safety and health plans, which would incur no costs.
Table VII-32 presents costs for affected facilities by provision. Incremental costs were estimated to be greatest for medical provisions followed by training. Personal protective equipment, in the form of portable kits, was also estimated to be a significant cost area, though the conditions under which an ocean lifeguard must perform his duties may limit its use. Based on information gathered during public hearings, OSHA estimated the level of current practice to be about 25 percent of the effort required under the standard with respect to training and personal protective equipment, and 50 percent with regard to follow-up procedures and appropriate sharps disposal devices.
TABLE VII-32 - LIFESAVING ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 1,860.8 4,652 6,513 65.13 Medical Provisions 60,722 96,852 157,623 1,576.23 HB Vaccination 60,722 78,395 139,167 1,391.67 Exposure Follow-up 0 18,456 18,456 184.56 Personal Protective Equipment 0 84,375 84,375 843.75 Gloves 0 0 0 0.00 Gowns 0 0 0 0.00 Masks 0 0 0 0.00 Goggles 0 0 0 0.00 Kits 0 84,375 84,375 843.75 Respirators 0 0 0 0.00 Training 14,166 125,167 139,333 1,393.33 Housekeeping 0 73,300 73,300 733.00 Sharps Disposal 0 60,300 60,300 603.00 Biowaste Bags 13,000 13,000 130.00 Waste Hauling 0 0 0.00 Engineering/Work Practice Controls 503 503 5.03 Handwasing/ Glove Change 503 503 5.03 Safety Syringes 0 0 0.00 Recordkeeping 5,092 7,134 12,225 122.25 --------------------------------------------------------------------- TOTALS $81,890 $391,982 $473,872 $4,738.72 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for the 6,321 school agencies affected by the standard were estimated to be about $6 million. An additional 10,742 agencies were estimated to incur no cost, as employees were located in states without state occupational safety and health plans.
Table VII-33 presents costs for affected agencies by provision. Training was estimated to be the area requiring the most significant commitment of additional resources. Information in the record suggested that very little training was currently provided; thus, OSHA estimated a baseline level of 0 percent for this provision.
Incremental costs for gloves and medical provisions, principally exposure-follow-up, were also estimated to be significant cost areas. Current compliance with respect to follow-up was also estimated to be zero. Current compliance with regard to personal protective equipment was estimated to be 25 percent.
Due to the limited quantities of potentially infectious fluids which workers would be expected to encounter in this sector, costs for personal protective equipment items other than gloves were small. No incremental costs for housekeeping were estimated, since very few potentially infectious waste items are expected to be generated.
TABLE VII-33 - SCHOOLS ______________________________________________________________________ Total Annual Annualized Recurring Annual Cost per Standard Provision First-year Cost Cost Facility Cost _____________________________________________________________________ Exposure Control Plan 117,621 294,053 411,674 65.13 Medical Provisions 145,549 1,253,214 1,398,763 221.29 HB Vaccination 145,549 235,357 380,906 60.26 Exposure Follow-up 0 1,017,858 1,017,858 161.03 Personal Protective Equipment 0 1,717,971 1,717,971 271.79 Gloves 0 1,457,390 1,457,390 230.56 Gowns 0 260,581 260,581 41.22 Masks 0 0 0 0.00 Goggles 0 0 0 0.00 Kits 0 0 0 0.00 Respirators 0 0 0 0.00 Training 458,727 1,644,514 2,103,241 332.74 Housekeeping 0 0 0 0.00 Sharps Disposal 0 0 0 0.00 Biowaste Bags 0 0 0.00 Waste Hauling 0 0 0.00 Engineering/Work Practice Controls 146,412 146,412 23.16 Handwasing/ Glove Change 146,412 146,412 23.16 Safety Syringes 0 0 0.00 Recordkeeping 22,866 173,411 196,277 31.05 --------------------------------------------------------------------- TOTALS $744,763 $5,229,575 $5,974,338 $945.16 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
Total annual incremental costs for waste removal operations affected by the standard were estimated to be $1.9 million. OSHA was not able to estimate the number of affected establishments and public refuse disposal organizations; however, 13,300 employees were estimated to be covered by the rule. Thus, costs were estimated to average $141 per affected employee.
Table VII-34 presents costs by provision. Personal protective equipment, in the form of portable kits, were estimated to comprise approximately three-quarters of overall compliance costs. Use was estimated to be quite frequent (one kit per week per affected worker). No costs were estimated for housekeeping, as workers in this sector do not generate potentially infectious waste items.
TABLE VII-34 - WASTE REMOVAL _____________________________________________________________ Total Annualized Recurring Annual Standard Provision First-year Cost Cost Cost _____________________________________________________________ Exposure Control Plan 930 2,326 3,256 Medical Provisions 67,996 154,965 222,960 HB Vaccination 67,996 152,990 220,986 Exposure Follow-up 0 1,975 1,975 Personal Protective Equipment 0 1,383,200 1,383,200 Gloves 0 0 0 Gowns 0 0 0 Masks 0 0 0 Goggles 0 0 0 Kits 0 1,383,200 1,383,200 Respirators 0 0 0 Training 16,959 232,124 249,083 Housekeeping 0 0 0 Sharps Disposal 0 0 0 Biowaste Bags 0 0 Waste Hauling 0 0 Engineering/Work Practice Controls 0 0 Handwasing/ Glove Change 0 0 Safety Syringes 0 0 Recordkeeping 7,353 3,328 10,681 --------------------------------------------------------------------- TOTALS $93,238 $1,775,942 $1,869,180 ______________________ Source: Occupational Safety and Health Administration, Office of Regulatory Analysis.
F. Economic Impacts and Regulatory Flexibility Analysis
OSHA developed quantitative estimates of the economic impact of the rule on the affected sectors. Data on profits are presented to illustrate the scale of affected industries and do not necessarily represent their ability to pay for the controls in question. Ability to pay is not related directly to profits because, as reported here, they do not net out all opportunity costs. The data on profits are calculated without making any adjustments for the normal rate of return that investors and entrepreneurs would demand for making risky investments of capital, time, effort and talent.
Our analysis is limited in that it does not distinguish between the average firm or unit and the marginal firm or unit. Although costs of compliance may be small for the representative firm in a particular sector, for a firm whose profitability is marginal and may be on the brink of financial distress, the costs of compliance could be more important.
Opportunity Cost and Resource Allocation of Social Regulation
The opportunity cost of an action is the value of the foregone alternative action. Ultimately, the concept of opportunity cost refers to foregone benefits. When action 'A' is chosen over action 'B', then the expected benefits of action 'B' should be counted as an opportunity cost of choosing action 'A'. Opportunity cost is generally equal to the greatest expected benefit that could be gained among possible alternatives.
The opportunity cost of the regulation for consumers is the value of the foregone purchases or investments that would otherwise be made. Consumers may adjust the quantity of goods purchased to increase total utility, which may include purchasing less health care. In any event, the opportunity cost is represented by the foregone benefits of spending the estimated compliance costs in other ways.
In the case of public institutions, such as fire stations, price increases for services rendered may not apply. Budgets are usually fixed (in the short run), and compliance costs are paid by reducing funds for other items in the budget. The opportunity cost of the standard, represented by the estimated compliance costs, is then the foregone benefit realized by spending this amount on other activities. Foregone benefits may include improvements in public safety, health and rescue services, etc. While the cost of compliance reduces funds otherwise available for many different worthy causes, compliance with the regulation provides significant benefits and is necessary for reducing significant risks to health care workers.
It should be noted that there are practical boundaries which limit the theoretical applicability of social opportunity costs. It would be inefficient and impractical, for example, to recommend a tax on health care providers enough to realize over $800 million in revenue which could then be applied to realizing more beneficial social goals than those achievable under the rule.
Nevertheless, opportunity cost remains a useful analytical tool, but within the more narrow bend of selecting the most socially beneficial goal from a limited range of social investments realistically open to health care providers. No evidence was presented to OSHA during the public hearings or submitted to the record on this rulemaking which stated that funds should be redirected away from occupational disease prevention and control to other more desirable and beneficial projects affecting health care workers. Greater benefits achievable through such a redirection were simply not identified.
This regulation will prevent illnesses and fatalities, which reduces total health care costs in addition to producing large nonmonetizable benefits for society. The benefits are concentrated in the health care sector, potentially increasing the efficiency of health care providers. Pain and grief avoided by otherwise infected workers combine with other direct benefits to employers including reduced insurance premiums, increased productivity, and lower employee turnover rates.
From a regulatory impact perspective, OSHA has identified the costs of compliance with the bloodborne diseases standard. Compliance costs include expenditures for engineering controls, work practices, personal protective equipment, training, vaccination, post-exposure follow-up, and other areas of risk reduction. As a result of these expenditures, health care providers in the private and public sectors will help to eliminate the risk of transmission of infectious diseases, thereby preventing a significant number of deaths and illnesses. In terms of economic impact, compliance expenditures represent a cost to society as a whole that will result in some combination of higher prices for health services, a reduction in profits (to some private health care providers) or limits on alternative public services.
In the private sector, compliance expenditures will, in the short term, direct resources toward risk reduction technologies in the field of bloodborne diseases. OSHA believes that unreasonable risk currently exists with regard to these health hazards and that anticipated compliance expenditures are appropriate and justified. In an economic sense, the social decision to regulate constitutes corrective action needed to offset imperfect market conditions unintentionally created, but nonetheless real, which have allowed health care providers to avoid costs associated with protective health measures for employees in the work place. Cost avoidance has resulted because necessary perfect market preconditions (which must exist in order for opportunity cost analysis and decision making to be optimal) have been compromised (worker compensation limiting employer liability) or do not exist (perfect information about risk and labor mobility). The absence of perfect market conditions and the accompanying need for corrective social regulation has been more fully discussed in the RIA section on Nonregulatory Alternatives.
In response to this rule, OSHA expects that resources in the private sector will be shifted from lower risk activities to risks associated with infectious diseases. In effect, time, equipment and personnel will be devoted less, in the short run, to activities with negative health impacts less clearly defined or with risks not as pronounced as the risks identified in this RIA. OSHA recognizes that although this resource reallocation may impose transactions costs (costs of learning, establishing contacts with vendors, trainers, etc.) on the private sector and on society, these costs are not expected to significantly impede the functioning of health care markets and the institutional relationships between providers, patients, equipment suppliers and customers.
To the extent the costs can be passed through the system, minor price increases may be felt by patients, customers and other downstream recipients of health services. OSHA believes that spillover benefits will accrue to society apart from the direct benefits attributed to the standard. The emergence of new types of equipment and technologies to prevent transmission of infectious diseases are a likely outcome of investments stimulated by this rule. Newer, more efficient PPE and engineering controls will replace older systems; new technologies and applications should lead to reductions in risk in other types of health care. Increased information transfer is expected, creating stronger health networks and a more highly developed system for communicating advances in the field.
Very little employment reallocation is envisioned under this standard. Enterprises may consider cutbacks in their employment of receptionists, lab technicians, laundry workers, etc., perhaps by reducing the number of hours the enterprises are open. But this will be countered by increased spending, under the standard, for goods and services -- including lab tests and laundering of PPE garments by the same enterprises.
In sum, OSHA recognizes that government faces opportunity costs when it chooses to regulate or not to regulate. Where the costs and benefits of private actions accrue solely to those who take those actions, the government ought to leave those actions alone. But where private and public actions have externalities in the form of harm to private citizens, society can intervene to assure that the costs of adverse consequences will accrue to entities which cause them. In the case of occupational safety and health, public policy makers face opportunity costs in the choice of acting to intervene or not acting. Government action imposes cost on firms and/or their customers. Government inaction leaves the cost and nonmonetizable burdens of inadequate safety and health on workers and the general public.
The standard, in effect, "internalizes external costs" that would otherwise be borne by society and individual workers and their families. The standard reduces costs to employers of workers getting infected (lower turnover, absenteeism, training costs and insurance premiums). Finally, in a practical sense, no alternative social initiatives affecting health care workers provide benefits which exceed those projected under the rule. The opportunity cost test of choosing the option which maximizes benefits and minimizes the foregone advantages of rejected options has been met for health care workers.
Quantitative Economic Impacts
Quantitative estimates of the economic impact of the rule on each affected sector were based on the cost figures presented above, information contained in the public record, and other published financial data. Impacts were computed at the industry level and are summarized in Table VII-35.
TABLE VII-35 - SUMMARY OF ECONOMIC IMPACTS
(For TABLE VII-35, Click Here)
The financial information appearing in column one of the table was obtained from the sources described earlier in the Industry Profile section of this Regulatory Impact Analysis, and were adjusted to exclude facilities not affected by the standard. The information appearing in column two (estimated pre-tax profits) was also presented earlier, and was generated by OSHA based on Dun and Bradstreet financial reports and corporate tax schedules. For example, with regard to physicians' offices, Dun and Bradstreet information indicated a post-tax profit margin (exclusive of physicians' salaries) of 5.5 percent. To calculate pre-tax profits, OSHA first applied this rate of post-tax profitability to the estimated overall revenue of affected establishments ($90 billion) to obtain post-tax profits. Next, OSHA used corporate tax schedules to estimate pre-tax profits. As shown in the table, compliance costs as a percentage of sector revenue (or budgets) ranged from 0.04 to 0.7 percent for affected establishments. Estimates of compliance costs as a percentage of pre-tax profits were less than 7 percent for most sectors; medical equipment repair facilities would experience the largest reduction in profit (8.4 percent). These estimates apply to the average firm in each sector. To the extent that compliance costs reduce profits, the burden on the marginal firms may be greater.
The degree to which affected firms will either incur or shift compliance costs depends largely on the competitive environment in which the firms operate and on the price elasticity of demand for the firms' services. Where the services offered are not very sensitive to price, affected firms can successfully raise prices to offset increased costs.
In general, when considered against recent indicators of the demand for and the costs of the types of services provided by establishments which would be affected by the rule, the economic impacts of the standard were not judged to be of sufficient magnitude to threaten the existence of any affected sector, nor were impacts judged sufficient to disrupt or otherwise adversely alter industry structure.
OSHA presents evidence below of strong demand for health care services. Recent trends show increasing expenditures on health care services during a period of rising costs to consumers. As described below, expenditures on health care services generally were estimated to have increased at rates ranging from 8 to 15 percent per year between 1987 and 1990. During the same period, costs to consumers also increased, at rates ranging from 6 to 11 percent. Recent cost-containment strategies have resulted in trends toward more cost effective health care delivery mechanisms, such as outpatient services. Establishments offering such services will continue to experience strong demand. OSHA believes that while cost containment is a growing concern in health care sectors, some portion of the costs of compliance associated with this rule will be passed forward to consumers. Strong demand will also assure most establishments of long term viable financial position with the associated ability to absorb compliance costs, if necessary, without experiencing undue harm. Some have expressed concern that the provisions of the standard could result in a decrease in the productivity of health care workers. However, OSHA believes that familiarization with the requirements and techniques will restrict time lost. Furthermore, OSHA believes any decrease in productivity will be offset by the peace of mind associated with a safer work setting.
OSHA developed a composite compliance indicator to assess the effect of current practices, or baseline position, on potential differential impacts within industries affected by the rule. In contrast to the sometimes widely divergent profiles of current practice obtained in connection with specific items or provisions (discussed above, Costs of Compliance), OSHA's composite indicator showed that for most sectors, composite compliance which represented a weighted average of baseline position with respect to personal protective equipment, training, and hepatitis B vaccination, was normally distributed. This characteristic reduces the potential of a disproportionate economic impact among affected establishments. Consequently, the relative level of effort required among potential competitors to achieve compliance with the standard is not expected to vary widely for most sectors(8).
__________ Footnote(8) OSHA's composite compliance indicator represents three major requirements under the standard, and has been used as a proxy for overall baseline position for the purposes of this analysis. OSHA believes this statistic to be a reasonable indicator of overall compliance because incremental costs associated with the three provisions represented in the indicator were consistently found to constitute a high portion of affected establishments' overall incremental compliance costs (see Costs of Compliance).
An additional factor affecting concentration, differential impact due to size, was also considered; however, no significant effect was found (see Regulatory Flexibility Analysis).
Following is a sector by sector assessment of the impacts of the OSHA rule. In each case, OSHA examined each sector's ability to pass forward or absorb compliance costs from existing margins. Recent trends and prevailing economic conditions are addressed.
Compliance costs were estimated to be 0.16 percent of affected physician office revenues and 2.6 percent of profits. This latter ratio, however, may not be a meaningful indicator of economic feasibility for this sector because most physician offices are owner-managed, and current tax laws provide strong incentives for distributing income as salaries or bonuses. Adjusting this ratio by adding an estimate of average physicians' income to the reported office profit shows that expected compliance costs represent less than 0.3 percent of total practitioner's income. Although costs of this magnitude would not result in a marked disruption in this sector even if borne entirely by these employers, evidence strongly suggests this sector will not bear the full cost burden.
According to the U.S. Department of Commerce, expenditures for physicians' services were estimated to increase at a rate of 15 percent between 1989 and 1990 [U.S. Industrial Outlook 1990, U.S. Department of Commerce, p. 49-1]. An increase of this magnitude in the expenditures for physicians' services during a period in which the costs of those services were estimated to have risen 7 percent (as reflected in the medical care services component of the 1989-1990 Consumer Price Index) indicates that fee adjustments in response to the OSHA rule can, to some extent, be passed forward to consumers and third party payers. (This option may be more limited in the future to the extent that Part B reimbursements under Medicare are restrained in an attempt to contain health care costs.) Increases in the costs of physicians' services have led to the proliferation of managed care systems, which have enabled many consumers (those with health insurance) to retain access to care at reasonable cost. Though the increase in the cost of care attributable to the OSHA standard is estimated to be relatively minor, this regulation may reinforce this trend.
Cost pass-through in the form of higher premiums paid by consumers or higher co-payments for health services may lead some consumers to shift away from managed care plans or to forgo preventive care altogether [Ex. 6-612]. Thus, while the ability of establishments to pass-through some of the costs associated with the rule was indicated, certain establishments may choose to absorb a large portion of the costs of compliance. Current levels of net income were estimated to be sufficient to enable establishments to comply fully with the rule.
The relative level of effort required to achieve compliance from baseline conditions was not judged to be widely divergent across this sector; most affected establishments are at a modest baseline compliance position.
Dental practices will incur compliance costs representing about 0.28 percent of revenues and 3.6 percent of estimated profits. After adjusting this ratio to reflect the average income of dentists, the expected compliance costs amount to less than 1 percent of total net income.
In contrast to physicians' offices, almost two-thirds of dental revenues are paid by direct consumer outlays [Ex. 13, IV-11]; thus, dentists may be less able than most other health care providers to pass forward the costs of compliance. However, impacts on net income were not estimated to be of sufficient magnitude to cause undue harm in this sector.
OSHA bases this conclusion on evidence of strong consumer demand for dental service. Evidence indicated consumer dental costs increased over 7 percent recently (as reflected in the medical care services component of the 1987-1988 Consumer Price Index); consumer expenditures also [U.S. Industrial Outlook 1990, U.S. Department of Commerce, p. 49-1]; and the number of dental practices remained fairly constant during the period (see Industry Profile above). The dental industry has been stable and competitive despite increasing costs to consumers which were an order of magnitude above those required by the standard. OSHA concluded that a 0.28 cost to revenue increase could be absorbed or passed forward by the dental sector, and would not result in industry contraction or greatly limit the public's access to care.
In its post-hearing brief, the American Dental Association (ADA) argued that the standard would have substantial impacts on dentists' profits and, more importantly, would limit access to dental care [Ex. 295, pp. 46-52]. However, the ADA based its argument on preliminary estimates of the incremental costs of compliance, as calculated by OSHA and the Association. OSHA believes these preliminary calculations and conclusions do not present a representative picture of the effects of the standard on the industry. The ADA's arguments also demonstrated the Association's apparent misunderstanding of the requirements and intent of the rule.
First, new evidence indicated certain preliminary estimates incorporated into OSHA and ADA calculations tended to overstate incremental cost. For example, based on testimony and written submissions, OSHA revised downward its estimate of the unit cost of a disposable mask, a frequently used item in the dental profession (see Technical Appendix C, Personal Protective Equipment). Also, OSHA's survey found rates of current compliance to be higher than originally estimated by either OSHA or the ADA(9).
__________ Footnote(9) In its post-hearing brief, the ADA disputes the validity of OSHA's multisector survey, from which rates of current compliance were estimated for use in this final analysis (Ex. 295, p. 20). See Technological Feasibility for a complete discussion of the representativeness of the survey results.
Second, the ADA noted that "OSHA's [preliminary] figure is understated in at least one important respect. It ignores costs for dentists who are not employees" [Ex. 295, p. 48]. Including incremental costs for non-employee dentists increased the ADA cost estimates by approximately 30 percent [Ex. 20-665, p. 28]. OSHA, however, correctly excluded non-employee dentists from its cost analysis, since the Agency may only enforce its standards when an employer-employee relationship exists. Dentists for whom the standard is not enforceable may voluntarily follow precautions required of employees, and are encouraged to do so, but no cost should be attributed to the standard for such voluntary activity.
Further, the ADA stated that "data... indicate that on average dentists who always use infection control methods charge 13.2 percent higher fees than dentists who use these methods less frequently" [Ex. 20-665, p. 29]. OSHA found this characterization of the potential impacts of the standard to be both vague and misleading. For example, the article referenced by the ADA concluded that "[i]n general, those dentists who always use [gloves, masks, gowns, and protective eyewear] charge higher fees than those dentists who use these methods less frequently" [Ex. 20-665, Appendix 6]. It is not clear from this conclusion how the author's use of the words "always" and "less frequently" relate to the requirements of the OSHA rule. The OSHA standard does not require employees to use gloves, masks, gowns, and protective eyewear at all times, but only to protect against blood exposure, which the ADA has stated occurs about 54 percent of the time [Ex. 295, p. 5, fn. 3]. Without more detailed explanation to clarify the referenced study, it is possible that dentists using the infection control measures "less frequently" are already in compliance with the standard. No indication of the relative frequencies of occurrence among dentists who "always" use the items as opposed to those who use the items "less frequently" is provided.
Finally, data reported by the ADA in connection with its 1988 survey of attitudes and behavior indicated that:
[t]he most important reasons cited by general dentists for not using barrier techniques were: loss of tactile sense, low risk, and difficulty in adapting to new techniques. Cost was not an important factor in this decision - it was cited by only 1 percent of respondents as the most important reason. [Ex. 282, Attachment 2B, p. 556]
This finding is inconsistent with the notion that infection control procedures threaten the financial health of the dental sector.
Thus, OSHA did not find the ADA arguments persuasive, and relied instead on survey results and other available industry information in reaching its conclusion of no significant impact. In addition to the direct costs of complying with the standard, dentists may also be subject to increases in the costs of equipment servicing. OSHA estimated that equipment repair firms would require a 0.6 percent increase in revenues in order to fully pass through the costs of the standard (see below). Assuming 50 percent of the costs of compliance for the medical equipment repair sector were attributable to servicing of dental equipment, and assuming 100 percent pass through to the dental sector, dentists costs for equipment servicing would increase from $84 million to about $87 million. Passing this cost through could result in an increase in dentists' fees of less than 0.01 percent.
Thus, OSHA concluded that the impacts of the standard will not result in disruption of the dental services sector. Data indicated that the incremental costs of compliance were not of sufficient magnitude to significantly alter either supply or demand for dental services.
Nursing Homes/Residential Care Establishments.
Compliance costs for nursing homes were estimated to be 0.15 percent of revenue and about 4.6 percent of pre-tax profits. (Profits for proprietary homes were estimated to be 75 percent of total profits.) Compliance costs for residential care facilities were estimated to average about 0.14 percent of revenues and 4.7 percent of profits.
Nursing homes were reported to be heavily dependent on government reimbursement programs, particularly Medicaid [Exs. 20-1356, p. 5; 20-255, p. 2; Tr. 9/21/89, p. 46]. It was also reported that some medicaid programs may not be able to provide adequate reimbursement for all participants. United Health, Incorporated, testified that "[b]ecause of the demands for the allocation of limited medicaid dollars, the nursing home industry is often not provided adequate resources to meet the current care demands" [Tr. 10/18/89, p. 395]. Further, it is not likely that these facilities will benefit from increased reimbursements in the short term, as the portion of public resources allocated for health care continues to be limited in an effort to contain costs.
Though this dependency on government programs ensures that "the burden cannot entirely be passed on to consumers" [Tr. 9/21/89, p. 46], future conditions should favor the long term care establishments, as the demand for beds rises in response to growth in the elderly population and increased life expectancy (this demand is reflected by estimates that expenditures on nursing home care increased at an average rate of approximately 11 percent from 1987-90) [U.S. Industrial Outlook 1990, U.S. Department of Commerce, p. 49-1, -4]. Limited public funds and increasing demand could result in industry concentration with fewer but larger, financially stronger facilities. The trend of increasing expenditures in a period of scarce public resources, however, also provides evidence that at least some pass through to private payers should be possible among existing establishments.
OSHA's composite compliance indicator showed that, in the nursing home sector, over two-thirds of surveyed establishments were estimated to fall within the baseline range of 40 to 80 percent. With regard to residential care facilities, about 14 percent of surveyed establishments were estimated to fall within the lowest baseline range (0-10 percent). Since incremental costs will be high for these establishments, the impact of the standard may tend to hasten consolidation in this sector.
Overall, OSHA found that the impacts associated with this regulatory action will not threaten the existence of the long term care industry, though restructuring may occur.
As shown in Table VII-35, OSHA estimated the cost of the standard at 0.14 percent of hospital revenues and 7.0 percent of hospital profits. Profit impacts were computed for proprietary hospitals only (estimated to constitute about 22 percent of the facilities in this sector) and were derived assuming an average total margin of 2 percent. Profits for hospitals were estimated to be $1.012 billion ($230 billion x 22% x 2%).
In assessing the ability of hospitals to pass the costs of compliance forward to consumers, OSHA examined recent data regarding hospital utilization, hospital expenses, and consumer expenditures. OSHA found that overall expenditures on hospital care were estimated to have increased steadily since 1987, on the order of 9 percent per year [U.S. Industrial Outlook 1990, U.S. Department of Commerce, p. 49-1]. At the same time, hospitals' costs rose 8-10 percent [1989 Hospital Statistics, American Hospital Association, p. xxxiii], and consumers paid 7.5 percent more for hospital services (as reflected in the medical care services component of the 1987-1988 Consumer Price Index). Revenues also increased 6.8 percent in 1987 and 9.3 percent in 1988 [1989 Hospital Statistics, American Hospital Association, p. xxxiii-xxxiv].
These data indicated that hospitals have succeeded in passing on to consumers a major portion of their increased expenses. As noted by OSHA in its preliminary analysis [54 FR 23106], third party payers bear a high percentage of the costs of hospital care, and it is likely that much of hospitals' cost increases were passed through to such payers. This conclusion is supported by the data presented above, which indicated demand for certain services remained strong despite significant increases in the costs of care.
However, to raise charges (prices) for inpatient services, hospitals rely on government programs, particularly Medicare, for increased reimbursements. Cost increases eventually result in higher reimbursements under the prospective payment system (PPS). Testimony indicated, however, that increases in federal medicare payments to hospitals for inpatient services are not likely to be sufficient to cover all cost increases [Tr. 9/27/89, pp. 58-59]. Thus, OSHA estimated that full pass-through would not be possible.
To more completely assess the impact of the standard in such an environment, a more detailed examination of the financial condition of hospitals and the prevailing trends in hospitals' health care delivery strategies was undertaken.
OSHA first examined hospitals' performance with respect to inpatient services. Average occupancy rates for hospitals averaged 65.5 percent in 1988, with the smallest hospitals (6-24 beds) reporting an average occupancy of 32.8 percent for the same year [1989 Hospital Statistics, American Hospital Association, p. xxxii]. Hospital admissions reported for 1988 declined 0.5 percent from the previous year, continuing a seven year downward trend [1989 Hospital Statistics, American Hospital Association, p. xxxi].
These reductions in admissions and accompanying drop in occupancy were largely due to PPS, which have set predetermined fee schedules intended to contain the escalating costs of hospital care. However, while the volume of inpatient services declined, cost per case continued to increase [1989 Hospital Statistics, American Hospital Association, p. xxxi].
Hospitals' inability to fully recoup cost increases through increased PPS reimbursements and increased patient charges (cost shifting) resulted in a period of consolidation, evidenced by increases in the closing of investor-owned facilities (which accounted for over 43 percent of community hospital closures in 1987) and by accelerated growth in the number of hospitals owned or managed by multi-hospital systems ["Prospective Payment Assessment Commission", Report to the Congress, June 1988, pp. 50, 51]. One example of a multi-hospital system is Presbyterian Health Care Systems. During testimony presented in Washington, D.C. Mr. Douglas Hawthorne of Presbyterian Hospital of Dallas, the "flagship" facility of the system, indicated that Presbyterian purchased rural hospitals in 1976 and 1984 [Tr. 9/27/89, p. 154].
To survive, hospitals increased their mix of services. One area where demand has grown significantly is outpatient services. In an effort to soften the financial impacts of cost containment strategies imposed on the industry by third party payers, hospitals began to treat more patients on an outpatient basis [1989 Hospital Statistics, American Hospital Association, p. xxv]. Consumer demand for outpatient care has continued to rise. According to the medical services component of the consumer price index, consumer costs for hospital outpatient services increased over 11 percent between 1989 and 1990; it appears that hospitals have been able to pass forward to outpatients some of their cost increases. (Increases in charges for outpatient services are also subject to approval by Medicare, (under Part B)).
Hospitals are also increasingly expanding their services to include long-term care [1989 Hospital Statistics, American Hospital Association, p. xxx], and some cost pass through should be possible in this area.
In contrast, hospitals will not be able to pass forward any of the costs of the rule in the area of uncompensated care. Hospitals are increasingly providing uncompensated care, and testimony presented during OSHA's informal public hearings emphasized this fact [Tr. 9/27/89, pp. 39, 229]. One study focused on the potential increase in uncompensated care in the treatment of AIDS patients [Ex. 6-637].
OSHA found it unlikely that compliance costs will be passed forward in full, although hospitals should be able to pass forward some portion of the costs of compliance. PPS updates have not increased reimbursement limits enough to fully compensate for hospitals' increased expenses with respect to inpatient care (and may not do so in the future). Hospitals have increased the volume of outpatient and long-term care services provided. Evidence indicated strong demand for these services, as recent trends clearly demonstrate that consumers and third party payers have borne some portion of hospitals' cost increases. Cost increases associated with the OSHA standard represent only a fraction of the recent cost increases experienced by hospitals and OSHA concludes that the effects of passing a portion of the costs of compliance forward will not result in a significant reduction in demand.
Hospitals' ability to absorb compliance costs which cannot be passed forward was also examined. As noted, a fair portion of hospitals' cost increases during the past several years were absorbed, resulting in declines in patient margins, some hospital closings and industry consolidation. (Patient margin is the percentage of patient revenue retained after expenses, in contrast to total margin, or the percentage of total revenue retained after expenses.) If the number of indigent patients increases, more hospitals will experience financial problems [Trs. 12/19/89, p. 852; 11/14/89, p. 318].
These effects do not appear to be evenly distributed among the nations hospitals. It was reported, for example, that during the 10 year period between 1978 and 1988 the number of urban community hospitals increased by 1 percent, while the number of rural community hospitals decreased by 12 percent [1989 Hospital Statistics, American Hospital Association, p. xxvi]. This was most likely due to population shifts and the differing characteristics of urban and rural hospitals; urban hospitals tend to be larger, on average, and are able to provide a greater variety of services; smaller hospitals tend to be more dependent on inpatient revenue and are less financially stable.
The regulatory impact will vary depending on a particular hospital's service area, current practices and means of financial support. For example, rural hospitals lag somewhat behind urban hospitals in current practices; thus, they may experience slightly greater impacts in attempting to comply with the standard due to weak baseline position. Also, some rural hospitals serving relatively isolated communities may not be able to alter their service mix to minimize costs and increase consumer expenditures. However, Congress and the Health Care Financing Administration (HCFA) identified sole community hospitals (SCH) as one group for which special treatment was justified with respect to PPS reimbursement limitations. SCHs, or those hospitals which constitute "the primary, and often the only, source of inpatient services for a market area" [Ex. 6-598, p. 3] are reimbursed in a manner which "gives greater weight to hospital-specific cost factors" and "become eligible for special payments in the event of a significant decrease in volume" [Ex. 6-598, p. 3]. Thus, it is likely that these hospitals may be able to pass forward, through third party payment, a larger portion of any cost increases resulting from the OSHA rule. It was also reported that rural hospitals often survive because of strong community support [Ex. 13, p. IV-13].
Patient mix will also affect a particular hospital's response to the rule. Hospitals with a larger medicare base and which provide significant amounts of uncompensated care may find it more difficult to pass costs forward, even as demand for services continues. One hospital's representative testified that 70 percent of all patients were medicare, and that 20 percent fell into the uncompensated classification [Tr. 9/27/89, p. 40]. The response of such hospitals to the OSHA rule will be to absorb a larger portion of the costs of compliance.
On balance, OSHA found the standard to be economically feasible for hospitals, but believes the rule will reinforce the present trend toward consolidation and service diversification. Though the volume of inpatient services has declined, the industry responded by consolidating to remove excess capacity, and by providing more outpatient services and long term-care. Demand for these alternative services should allow some portion of the costs of this standard to be passed forward to consumers, particularly in the case of larger hospitals, as they are more likely to be able to offer a diverse range of services. The reduction in excess capacity will result in a more financially stable industry better able to absorb costs which cannot be passed forward. If it is assumed that substantial portions of the annual compliance costs incurred by blood collection and processing centers, personnel service agencies, linen services, and medical equipment repair establishments will be passed forward to hospitals (approximately $25 million), projected impacts would increase by only about 8 percent (an additional 0.01 percent of revenues, or 0.6 percent of profits). The magnitude of these impacts, when contrasted against past and prevailing financial trends in this sector, should not present hospitals with new, unmanageable burdens.
Also, many publicly administered hospitals will not be affected by the standard. It was estimated that about 10 percent of hospitals were state, county, or city funded [Ex. 266]. Such hospitals would also have a slight competitive advantage over non-public institutions. However, as noted above, the magnitude of cost increases associated with the standard were estimated to be relatively small, and should not create significant economic hardship for most affected hospitals.
Medical and Dental Laboratories.
The impacts of compliance costs were estimated to be 0.28 percent of revenues, or 3.8 percent of profits for establishments in this sector.
The response of labs which provide testing services to other health care providers, such as physicians and dentists, will most likely be to attempt to pass costs forward to such health care professionals. Since data indicated that strong demand for health care services should enable providers to pass some portion of the costs associated with the rule on to consumers, OSHA estimated that some portion of the compliance costs incurred by medical and dental labs will be passed on as well. Labs billing consumers directly will also attempt to push costs forward.
Since some consumers may forgo preventive care in an environment of rising charges, labs will find that a fair portion of the costs will need to be financed through absorption. OSHA's calculations did not, however, indicate profit impacts to be sufficient to cause disruption in this sector. Differential impacts on establishments resulting from their low baseline position could occur, though any competitive impact would be mitigated by the overall weak baseline profile of the industry.
Other Health Care Facilities.
Home health care, hospices, freestanding hemodialysis centers, and drug rehabilitation centers are included in this sector. As shown in Table VII-35, the impacts of compliance costs on revenues for establishments specializing in outpatient services range from less than one-tenth of 1 percent (drug rehabilitation centers) to just under 0.2 percent (hemodialysis centers). Compliance costs represent about 1 percent of profits for drug rehabilitation centers and about 3.1 percent of profits for hospices.
OSHA finds that current trends in health care delivery strategies favor providers which treat in the home or on an outpatient basis. The demand for home health services has grown steadily recently. The Commerce Department reported that "spending on home health care has been growing at an annual rate of about 20 percent for the past few years," reflecting both the advancing age of the population and incentives encouraging alternatives to institutionalization [U.S. Industrial Outlook 1990, U.S. Department of Commerce, p. 49-4]. Hospices also provide such an alternative.
There was little available information on dialysis and drug rehabilitation center. Since these establishments primarily provide services on an outpatient basis, OSHA judged the outlook for these sectors to be financially favorable. Recent financial information published by Dun and Bradstreet indicated dialysis centers were achieving good returns, with median firms earning in excess of 8 percent on sales (after taxes) in 1988 and 1989. Continued demand should ensure the ability of affected centers to finance the costs of the rule through a combination of pass- through and absorption.
Health Units in Industry.
OSHA estimated total costs for health units in manufacturing facilities to be almost $68 million. However, these costs will be shared by over 200,000 establishments. OSHA concluded that, since health units are typically found in large businesses, the costs associated with the standard will have a negligible impact on affected manufacturing plants and will not affect producers' market structure.
Compliance costs for personnel firms supplying medical care staff and service employees are estimated at 0.25 percent of revenue and 6.3 percent of related profits.
Information regarding the demand for temporary staffing is limited and mixed. On the positive side, the continued emphasis being placed on outpatient and home care services should provide a growing market for temporaries. Information provided by the Home Health Services and Staffing Association (HHSSA) indicated, however, that, to the extent that families pay for home care services out of private funds, such services are "very price-sensitive" [Ex. 20-878, p. 3].
In contrast, the downturn in the demand for hospital inpatient services and the consolidation of both the hospital and long term care sectors have led to "a decline in the requests for temporary services in many areas of the country" [Ex. 20-878, p. 3].
Thus, OSHA concludes that total pass-through of compliance costs may not be possible for establishments in this sector. However, some avenues for pass-through should be available, and continued demand for home and long-term care should enable this industry to absorb the balance of the economic impacts of the standard.
OSHA's composite compliance indicator suggests that a substantial number of establishments may experience greater impacts due to a weak baseline position. OSHA estimated 28 percent of all surveyed establishments to have achieved an average level of current compliance which was 10 percent or below. However, since over 70 percent of establishments surveyed were estimated to have achieved a baseline position of 50 percent or below, the effects of a disproportionate allocation of incremental costs is not be expected.
Other Related Services.
These services include blood/plasma/tissue centers, linen supply services, medical equipment repair services, and funeral services. With regard to blood products, OSHA estimated compliance costs to represent 0.8 percent of total revenue. By the nature of their product and the structure of the blood services industry, full pass-through of compliance costs should be possible for this sector. The inelasticity of demand for blood products, coupled with the regional structure of the industry and the absence of a regulated pricing system, indicates that the 1 to 2 percent increase in costs associated with the standard will be passed forward to the consumers of health care, third party payers and, to a lesser extent, hospitals. In addition, OSHA's composite compliance indicator did not suggest a great potential for the disproportionate allocation of incremental costs.
In the linen services sector, increases in charges equivalent to 0.04 percent of revenue are expected to be passed forward to health care clients. This conclusion is supported by evidence in the record indicating a shift away from in-house laundries by hospitals toward contract laundry services. This trend, which has been taking place over the past 5 to 10 years, is expected to continue [Ex. 20-106]. The continued demand for linen services should enable linen service establishments to pass forward costs associated with the rule. The cost increase should not eliminate the advantage realized by health care establishments utilizing contract linen services.
Establishments servicing medical and dental equipment are also in a strong position to pass forward most or all of the costs associated with the rule. OSHA estimated that dental offices should be able to absorb any costs passed forward by equipment repair establishments, as the magnitude of such costs were estimated to be a very small portion of dentists' net income. Similarly, OSHA estimated the hospital sector to be able to manage increases in the costs of equipment repair associated with the rule, by using a combination of pass-through and absorption. OSHA disagrees with the American Dental Trade Association's (ADTA) contention that the OSHA standard will "create a strong incentive for companies to cease repair operations" [Ex. 20-1144]. The need to maintain complex and expensive equipment will continue and support the continued demand for establishments with expertise in this area.
Some equipment repair establishments may find their poor baseline position to be a disadvantage, as thirteen percent of surveyed establishments were estimated to have achieved average compliance levels of 0 to 10 percent. The balance of affected establishments were estimated to have achieved average compliance levels of no more than 50 percent, however, thus reducing the potential of a concentrated impact of the rule.
The costs of compliance in the funeral homes sector were estimated to be 0.13 percent of industry revenue, or just under 1.5 percent of profits. OSHA estimates that continued demand for the services provided by establishments in this sector should enable them to push most costs of the rule through to buyers. With respect to the rule's possible effect on industry structure, OSHA's composite compliance indicator did not suggest a great potential for the disproportionate allocation of incremental costs.
Research and Production Facilities.
OSHA estimated the costs of compliance to represent 0.18 percent of total revenues and 4 percent of profits for this sector.
Many research projects are supported by public funds, such as those conducted in state and local institutions of higher learning or in association with federal grant programs. However, corporate and private donations are essential in both public and private research. Though OSHA has no data on the sensitivity of these sources of support to increases in the costs of performing research, it is anticipated that the ability to pass costs forward would be greater for establishments relying more heavily on corporate funding than on public grants. Since evidence was presented indicating over one-half of the estimated research dollars are spent on research performed by private labs and labs in the pharmaceutical industry [Ex. 13, p. I-44], OSHA believes that some portion of the costs of compliance will be passed forward in the form of higher prices for corporate products or services.
Establishments relying primarily on public funding for research may be forced to absorb the costs in full. However, costs, as percentages of profits and revenues, are small and are not expected to have a significant effect on the ability of firms to operate.
OSHA estimated the costs of compliance to represent just over 0.3 percent of industry revenues and approximately 4.2 percent of pre-tax profits.
Generators of regulated waste have three main alternatives with respect to disposal of such waste. First, wastes may be rendered noninfectious prior to disposal, thus enabling generators to use a general waste stream. A second way many generators dispose of regulated items is to incinerate on site. Generators not equipped to treat or incinerate items on site will be required to have regulated items collected and transported off site for subsequent disposal or treatment.
Relatively few of the establishments affected by the standard generate enough waste to justify investment in incineration equipment, with the exception of hospitals, on-site incineration would not be cost-effective for most facilities faced with a 0.3 percent increase in transportation costs. However, OSHA found many affected establishments operate autoclaves (steam sterilization equipment) on-site. Generators may find it cost effective to invest in new steam sterilization equipment, thus altering their current treatment/disposal strategy to minimize disposal costs.
In the case of hospitals, data from one survey indicated that 80 percent of infectious (regulated) items were treated before disposal [Ex. 6-609]. Many hospitals appear to have some ability to avoid increased collection/transportation costs in connection with regulated waste items.
Since generators of regulated waste can avoid some or all of the costs associated with collection and transportation of regulated items, OSHA estimates that the incremental costs of compliance incurred by waste removal establishments may be absorbed by affected firms. The impact of this absorption is not expected to be overly burdensome to this industry sector.
Public Service Sectors.
Compliance costs for government clinics, corrections, police, fire and rescue operations, lifesaving, and schools were estimated to amount to less than 0.5 percent of the budgets in all cases. Though collective increases of this magnitude represent increases in public expenditures of less than $0.50 per capita for state-plan states, local governments may choose to forgo tax increases and procure additional resources for public services affected by the standard through shifting resources away from less essential services. Localities choosing to finance compliance costs through tax increases or service charges should find incremental tax burdens or service charges to be relatively small.
Regulatory Flexibility Analysis.
Based on data presented by Jack Faucett Associates, OSHA preliminarily concluded that the impact of the rule on small businesses would be similar to that found for the affected universe as a whole, because the majority of businesses affected are small [54 FR 23107]. Table VII-36 shows the estimated percentage of affected establishments by sector reporting annual income of $3.5 million or less. The table reflects how hospitals differ from other affected industry sectors, and the majority of the revenues in five sectors is generated by larger establishments.
TABLE VII-36 - SECTOR COMPOSITION - SMALL ESTABLISHMENTS Percent of Firms With Percent of Revenue of Less than Revenue from Industry 3.5 million Small Business ____________________________________________________________________ Offices of Physicians 99.32 88 Offices of Dentists 99.97 88 Nursing Homes 87.47 48 Hospitals 28.64 2 Medical/Dental Labs 98.59 58 Outpatient Care 98.02 45 Home Health Care Hospice Care Drug Rehabilitation Hemodialysis Cemters Residential Care 97.60 75 Personnel Services 90.54 34 Funeral Services 99.61 90 Research Labs 91.63 14 _____________________ Source: Jack Faucett Associates
OSHA compared the composite compliance indicator profiles presented in Technical Appendix B for seven employment-size categories in each surveyed sector (five employment-size categories were developed for the hospital sector)(10). By examining the baseline profiles of smaller establishments, or the extent to which smaller establishments have already implemented worker protection measures, insight was gained with regard to smaller establishments' relative abilities to supplement such measures to comply with the rule. OSHA used the profiles to generate the information presented in Table VII-37, the implications of which are explained below.
__________ Footnote(10) Employment size categories for non-hospital sectors were 0-4; 5-9; 10-19; 20-49; 50-99; 100-249; >250. Employment size categories for hospitals were 1-49; 50-99; 100-249; 250-499; >500. Though OSHA's bloodborne pathogens survey was not designed to produce statistical estimates by size class, the compliance estimates discussed here are believed to be generally accurate and useful for illustrative purposes. TABLE VII-37 - SMALL ESTABLISHMENT BASELINE ANALYSIS
(For TABLE VII-37, Click Here)
As shown in the table, OSHA included in the analysis establishments employing fewer than 10, 20, or 50 employees. OSHA sought evidence that smaller establishments were overrepresented in the lower baseline ranges (0 to 30 percent average compliance). As shown in Table VII-37, for most sectors, this was not the case. For example, in dentists' offices, establishments were found in the lowest baseline ranges in proportion to their representation in the universe of affected establishments as a whole, regardless of employment-size class. This pattern was exhibited by many of the surveyed sectors, including nursing homes, home health care facilities, personnel service establishments, and medical equipment repair establishments. In three sectors (dialysis centers, blood centers, and residential care facilities), a trend toward larger establishments' overrepresentation in the lowest baseline ranges was found. However, in physicians' offices, establishments employing 10 or fewer employees made up 92 percent of establishments falling into the lower baseline ranges but only 76 percent of the population of affected entities. Smaller establishments in the hospice and medical/dental laboratories sectors also appeared to lag behind larger establishments with respect to employee protection against infectious agents.
These figures suggested that, for most sectors, smaller establishments generally have not experienced greater difficulty in implementing employee protection measures relative to larger establishments. Nevertheless, in some sectors, smaller establishments may need a relatively greater effort than larger facilities in achieving compliance. However, OSHA's baseline profile also indicated that a substantial number of small facilities fall into the higher compliance ranges in these sectors; small size alone did not preclude implementation of voluntary employee protection measures. For example, 67 percent of surveyed physicians' offices with fewer than 10 employees were estimated to have achieved a baseline position exceeding 30 percent, and almost one-third were estimated to have achieved a baseline position exceeding 50 percent.
Thus, OSHA did not find smallness associated with an inability to comply with the rule or to necessarily place small establishments at competitive disadvantage under the rule.
With regard to the hospital sector, small firms make up about 29 percent of the affected universe when revenue in used as the primary criterion to establish size. However, OSHA's baseline analysis indicated only 4 hospitals have failed to achieve an average compliance level of 31 percent. Though these four hospitals all reported fewer than 250 employees and fewer than 300 operating beds, hospitals of this size constituted over 25 percent of all hospitals included in the analysis.
Thus, while smaller hospitals' limited ability to diversify could be a potential disadvantage in their attempts to pass compliance costs forward, it does not appear that they lag behind larger hospitals to any significant extent in their ability to provide employees with protection against infectious hazards. These findings support OSHA's earlier assessment with regard to regulatory flexibility. Based on these findings, OSHA reaffirms its conclusion that impacts on small businesses will generally conform to the impacts of the standard upon the affected universe as a whole. Though some smaller establishments may experience impacts which exceed those placed upon competitors, differential impacts should not alter industry structure to any significant degree.
G. Nonregulatory Environment and Regulatory Alternatives
Under the requirements of Executive Order 12291 and the Office of Management and Budget (OMB) guidelines for its implementation, regulatory agencies must consider nonregulatory alternatives when reviewing a standard. Many proposals have been advanced as solutions to the complex problem of reducing occupational health hazards and the attendant economic burden they place on affected workers, employers, and society at large. While these proposals form a continuum in their distribution of costs and benefits, they generally fall into categories based on the degree to which market forces are relied on to reduce workplace hazards.
2. Workers' Compensation and Tort Liability
Some market-based approaches for dealing with occupational illness rely on the theory that workers' compensation and tort liability provide adequate incentives for employers with high injury and illness rates to improve workplace conditions. Workers' Compensation programs, however, are generally not adequate to ensure an efficient allocation of health resources. The rates charged employers tend not to serve as an economic incentive as only 20 percent of all firms (mostly large firms) are experience rated. Since the universe of establishments affected by the bloodborne pathogens standard consists predominantly of small establishments, it would be unlikely that many workplaces would be rated.
Additional obstacles to Workers' Compensation providing incentives for workplace health and safety are the usual limitation of benefits to less than two-thirds of weekly wages, restricted permanent disability benefits, and limited survivor benefits.
This situation is further complicated by the nature of occupational diseases, which may take years to develop. For example, the long latency period prior to the development of acquired immunodeficiency syndrome (AIDS) may make it difficult to obtain Workers' Compensation benefits for occupationally induced illness.
In short, the Workers' Compensation system does not provide adequate incentives for employers to invest in a more healthful workplace because benefits are below the actual costs of injury, and because premiums for individual firms do not directly hinge on the level of risk they impose. The economic costs not borne by the employer are shifted to the employee, their families, or to society as a whole through social security or welfare programs. The threat of litigation under tort liability has also been propounded as an effective market incentive to provide a more healthful work environment. The potential effectiveness of tort liability, however, is limited by the fact that, in most instances, workers are precluded from suing employers by Workers' Compensation statutes. Moreover, workers often cannot afford to forgo Workers' Compensation benefits while awaiting settlement, especially when there is a low probability of winning the lawsuit. In addition, workers may not be able to afford the costly legal fees associated with protracted litigation. Indeed, the threat of litigation may have the effect of suppressing information, especially when employers are vulnerable to third-party liability suits. Thus, the probability of a successful outcome from litigation involving an occupational illness is small due to the absence of definitive information concerning hazards and the related difficulty of proving employer negligence.
3. Private Markets
Neoclassical economics assumes that a perfectly functioning labor market will efficiently allocate occupational safety and health resources and that government intervention is warranted only when a market failure occurs. According to this view, workers will bargain for wages which will compensate for their expected losses as a result of occupational risks, while employers will reduce the risks in order to reduce their labor costs. This theory typically assumes perfectly competitive labor markets in which workers, having perfect knowledge of job risks and being perfectly mobile between jobs, command wage premiums that fully compensate them for the risk of a future occupational illness. Theoretically, the cost of occupational illness is borne initially by the firms responsible for the unhealthy workplace and, ultimately, by the consumers who pay higher prices for the final goods and services produced by the firms. With all costs internalized, private employers have an incentive to reduce the level of risk in the workplace wherever the cost of doing so is less than the cost of the expected illness. The resultant level of health protection is considered "efficient" in that it minimizes the sum of the costs of health protection and of illness.
There is mixed evidence, however, on the extent to which workers are compensated for on-the-job health hazards. Although a number of wage surveys have found that many riskier occupations do receive wage premiums, no empirical studies necessarily imply that workers are fully compensated for bearing such risk. There are several reasons why wage differentials may not correspond to the actual occupational risk to which the worker is exposed. Perfectly competitive markets, which require fully informed individuals, mobile resources and internalized costs, do not exist in all labor markets. While job health resources would be supplied by the private market under perfect market conditions, these conditions are rarely met. Thus, one rationale for the need for government regulation to reduce occupational illness is to correct for the "market failure" due to the absence of accurate risk information, the immobility of labor, and the externalization of part of the social costs of worker illness or death. These factors lead to an undersupply of investment in occupational health protection.
The problem of imperfect information regarding job hazards exists in many workplace settings. Most occupational illnesses are only statistically associated with specific jobs. The incidence of a particular malady in a group of workers is higher than in the general population. It is very difficult to predict illness on a case-by-case basis. Cause and effect analysis by long latency periods for many diseases. Persons exposed to particular risks may not know precisely what those risks are and may either overestimate or underestimate them. Without knowing exact levels of risk it is not possible to successfully negotiate wage differentials which adequately compensate for accepting that level of risk. Illness and health effects data often are of poor quality and private firms have little incentive to improve or disseminate them. Where data are available, they are seldom presented in terms that would help workers to make informed decisions. Moreover, even if such data were available, workers may not be able to translate them into a probability of disability or death. If workers cannot adequately evaluate their individual risks, their ability to bargain effectively with their employers for compensation or for healthier working conditions is severely impaired.
The problem of imperfect information dissemination, while common to all areas of safety and health, is particularly pronounced for health risks. Adverse health effects caused by exposure to hazardous substances may have symptoms similar to diseases which are not necessarily occupationally related. This complexity precludes informed decisions being made based on the likely consequences of occupational exposure to harmful substances or conditions.
Another cause of market inefficiency is inadvertently created by entitlements under Social Security disability and other social welfare programs. Although these programs do not affect occupational risk, they in fact absorb part of the loss produced by job-related illness and injury, in turn fixing part of the cost of occupational risk on the general public rather than on the workers and employers who negotiate in the labor market. To the extent that the public pays for the consequences of risk, workers in hazardous jobs will have a smaller incentive to bargain for compensating wage differentials. Reduced wage differentials lessen the incentive to abate the hazard. Thus, one of the reasons that the private market does not perform perfectly in reducing accident and illness rates is that workers and employers have been allowed to externalize the costs of workplace illness and injury to society in general.
A perfectly competitive labor market also requires that workers have the ability to move freely from job to job with few transaction costs. But, localized demand for occupational skills and widespread fears of unemployment restrict labor's ability to bargain for safer workplace conditions. Considering the substantial loss of income resulting from prolonged periods of unemployment, the practical choice for many workers is not between a safe job and a more hazardous but higher paying job, but rather between employment and unemployment at whatever the prevailing rate of pay and risk. The high cost of relocation, the cost of breaking family and community ties, and the growth of institutional factors such as pension plans and seniority rights also elevate the cost of job transfer. Thus, for situations in which wages are more responsive to the demands of more mobile workers (who tend to be younger and perhaps less aware of job risks), hazard premiums for the average worker will not be fully compensating, and the obtained level of health will be less than that required for economic efficiency.
4. Action taken by Employers Based on Non-enforceable Guidelines
In 1987, the Centers for Disease Control (CDC) of the United States Department of Health and Human Services (HHS) published guidelines for safety when working with blood or other potentially infectious materials. Though research performed by OSHA indicated that some level of worker protection has been instituted in most establishments where exposure to infectious substances occurs, this information, together with comments received by the public, clearly demonstrates that non-enforceable guidelines will not result in an adequate level of protection to the nation's health care and public safety workforce.
To ensure the best possible protection to the population at risk to bloodborne pathogens, an integrated system of controls, procedures, training, and medical measures are required, and the OSHA standard was designed to be implemented in such a fashion. Though current practices with regard to the use of gloves by affected workers were found to be largely in compliance with the OSHA rule, adequate levels of training were found less often. Training in the appropriate use of gloves is an important component of the rule.
In the absence of this regulatory option, significant gaps will remain in many establishments' worker protection programs. Enforceable workplace standards will ensure that employers will institute a complete set of risk reduction policies and procedures, the most effective and efficient way to maintain a safe and healthful workplace.
5. Other Regulatory Alternatives
Since universal precautions were introduced by CDC, the concept has received overwhelming support by worker and industry groups alike. In light of such evidence, OSHA concluded that the most effective regulatory approach for limiting exposure to bloodborne infectious agents was to mandate the adoption of universal precautions, a system whereby all blood and other materials which may contain bloodborne pathogens are considered potentially infectious.
However, while the concept of universal precautions is generally acknowledged as prudent and effective, OSHA determined that a more complete worker protection program would be required to ensure maximum worker protection. That is, while universal precautions are a necessary element in any comprehensive program where exposure to blood is to be limited, the concept is not in itself sufficient if worker safety is to be maximized.
Thus, OSHA has also required the hepatitis B vaccine to be offered to occupationally exposed employees free of charge. Three alternatives to this requirement were considered. First, OSHA considered limiting the population of workers offered the hepatitis B vaccine to that portion of the affected workforce occupationally exposed an average of once a month or more. OSHA's second alternative was to require all employers to offer the vaccine, free of charge, to occupationally exposed workers, regardless of frequency of exposure. A third alternative would be to mandate the vaccination of all exposed employees. However, this alternative would not protect workers from other bloodborne pathogens.
A review of public comment and testimony indicated strong support for the second of the three alternatives listed above. If vaccine eligibility had been based on monthly exposure, many workers at risk would not have qualified for the vaccine. OSHA chose to mandate that employers offer the hepatitis B vaccine to all occupationally exposed workers.
OSHA also considered mandating specific control methods or technologies for worker protection. However, while specification standards may be appropriate for processes or systems incorporating minimal variation in tasks and predictable hazards, such a regulatory approach would not be well suited to health and emergency care workplaces. Most sectors providing health care and related services require employees to confront an array of potentially hazardous scenarios, many of which are unpredictable or unanticipated. Prescribing strict procedural or technological requirements in a hospital, where workers consistently face unique and varied exposure situations, would invite conflict between specific rule requirements and the need to provide essential health care services. Strict requirements in association with such a dynamic environment would become outdated, as new treatments and advances in medical science are implemented.
Thus, OSHA has drafted a performance oriented standard, allowing employers to craft the most protective and cost effective programs possible. OSHA is confident that employers will be able to minimize risk to occupationally exposed workers by training workers to employ effective and efficient risk reduction techniques, such as work practices to reduce the potential for exposure, engineering controls, or proper use of personal protective equipment, when confronted with occupational exposure.
Two alternatives in connection with the requirement that employers provide post-exposure follow-up to employees following exposure incidents were considered. The first involved mandating that follow-up procedures be performed in accordance with standard recommendations for medical practice. The alternative to this option was to mandate that follow-up procedures be performed in accordance with Public Health Service (PHS) guidelines. OSHA chose the second alternative, since recommendations for standard medical practice generally follow PHS guidelines. This will ensure that workers are provided the best follow-up care as soon as possible.
- [56 FR 64004, Dec. 6, 1991; 57 FR 29206, July 1, 1992]
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