Federal Registers - Table of Contents Federal Registers - Table of Contents
• Publication Date: 05/06/2010
• Publication Type: Proposed Rules
• Fed Register #: 75:24835-24844
• Standard Number: 1910; 1910.1030; 1910.134; 1910.132; 1910.145; 1911
• Title: Infectious Diseases

[Federal Register: May 6, 2010 (Volume 75, Number 87)]
[Proposed Rules]               
[Page 24835-24844]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06my10-17]                         

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. OSHA-2010-0003]
RIN No. 1218-AC46

 
Infectious Diseases

AGENCY: Occupational Safety and Health Administration (OSHA), 
Department of Labor.

ACTION: Request for information.

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SUMMARY: OSHA requests information and comment on occupational exposure 
to infectious agents in settings where healthcare is provided, (e.g., 
hospitals, outpatient clinics, clinics in schools and correctional 
facilities), and healthcare-related settings (e.g., laboratories that 
handle potentially infectious biological materials, medical examiner 
offices and mortuaries). OSHA is interested in strategies that are 
being used in such healthcare and other healthcare-related work 
settings to mitigate the risk of occupationally-acquired infectious 
diseases. As such, OSHA would like to collect information and data on 
the facilities and the tasks potentially exposing workers to this risk; 
successful employee infection control programs; control methodologies 
being utilized (including engineering, work practice, and 
administrative controls and personal protective equipment); medical 
surveillance programs; and training. OSHA will use the information 
received in response to this request to determine what action, if any, 
the Agency may take to further limit the spread of occupationally-
acquired infectious diseases in these types of settings.

DATES: Comments must be submitted by the following date:
    Hard copy: Your comments must be submitted (postmarked or sent) by 
August 4, 2010.
    Facsimile and electronic transmission: Your comments must be sent 
by August 4, 2010.

ADDRESSES: You may submit comments and additional materials by any of 
the following methods:
    Electronically: You may submit comments and attachments 
electronically at http://www.regulations.gov, which is the Federal 
eRulemaking Portal. Follow the instructions online for making 
electronic submissions:
    Fax: If your submissions, including attachments, are not longer 
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648; or
    Mail, hand delivery, express mail, messenger or courier service: 
You must submit three copies of your comments and attachments to the 
OSHA Docket Office, Docket No. OSHA-2010-0003, U.S. Department of 
Labor, Room N-2625, 200 Constitution Avenue, NW., Washington, DC 20210. 
Deliveries (hand, express mail, messenger and courier service) are 
accepted during the Department of Labor's and Docket Office's normal 
business hours, 8:15 a.m.-4:45 p.m., EST.
    Instructions: All submissions must include the Agency name and the 
OSHA docket number for this rulemaking (OSHA Docket No. OSHA-2010-
0003). Submissions, including any personal information you provide, are 
placed in the public docket without change and may be made available 
online at http://www.regulations.gov.
    Docket: To read or download submissions or other material in the 
docket, go to http://www.regulations.gov or the OSHA Docket Office at 
the address above. All documents in the docket are listed
in the http://www.regulations.gov index, however, some information 
(e.g., copyrighted material) is not publicly available 
to read or download through the Web site. All submissions, including 
copyrighted material, are available for inspection at the OSHA Docket 
Office.

FOR FURTHER INFORMATION CONTACT:
    Press Inquiries: Jennifer Ashley, Director, OSHA Office of 
Communications, Room N-3647, U.S. Department of Labor, 200 Constitution 
Avenue, NW., Washington, DC 20210; telephone: (202) 693-1999.
    General and Technical Information: Andrew Levinson, Director, 
Office of Biological Hazards, OSHA Directorate of Standards and 
Guidance, Room N-3718, U.S. Department of Labor, 200 Constitution 
Avenue, NW., Washington, DC, 20210; telephone: (202) 693-2048.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Background
    A. Introduction
    B. History of Occupational Safety and Health Regulations 
Addressing Protection of Workers From Infectious Diseases
    C. Summary
II. Request for Data, Information and Comments
    A. General
    B. Infection Prevention and Control Plan
    C. Methods of Control
    D. Vaccination and Post-Exposure Prophylaxis
    E. Communication of Hazards
    F. Recordkeeping
    G. Economic Impacts and Benefits
    H. Impacts on Small Entities
III. Public Participation

I. Background

A. Introduction

    In 2007, the healthcare and social assistance sector as a whole had 
16.5 million employees.\1\ Healthcare workplaces can range from small 
private practices of physicians to hospitals that employ thousands of 
workers. In addition, healthcare is increasingly being provided in 
other settings such as nursing homes, free-standing surgical and 
outpatient centers, emergency care clinics, patients' homes, and pre-
hospitalization emergency care settings. Over the last 10 years, the 
number of healthcare workers (HCWs) (defined as healthcare 
professionals, technicians, and healthcare support workers, including 
those not directly providing patient care such as maintenance or 
laundry workers) has increased from 8.4 million in 1998, to 
approximately 11 million in 2008. In 1998, of the 8.4 million HCWs, 3.0 
million were employed in hospitals and 5.4 million were employed 
outside of hospitals. In 2008, 3.6 million HCWs were employed in 
hospitals and 7.3 million outside of hospitals. Of the 7.3 million 
workers employed outside of hospitals, 2.1 million were employed by 
establishments not defined as part of the healthcare sector.\2\ The 
increasing number of HCWs outside of hospital settings who are exposed 
to occupational injuries and illnesses likely has implications for risk 
management.
    Depending on the setting and the job tasks, HCWs may be exposed to 
a number of occupational hazards including: Exposure to infectious 
agents, radiation and chemicals. The Bureau of Labor Statistics (BLS) 
reports that for 2008, the incidence of all occupational injury and 
illness (including musculo-skeletal disorders from slips and falls and 
lifting patients and equipment) in the healthcare sector as a whole was 
5.6 cases per 100 full-time workers, in contrast to an average of 4.2 
cases per 100 full-time workers for private industry overall.\3\ Higher 
rates have been documented in hospitals, with an incidence rate for all 
injuries and illnesses of 7.6 per 100 full-time workers, and nursing 
homes, with an incidence rate for all injuries and illnesses of 8.4 per 
100 full-time workers.
    In addition to settings where healthcare is provided, there are 
other work settings where workers might be at increased risk for 
occupational exposure to infectious agents. Occupational exposure to 
infectious agents may occur in settings where healthcare is provided 
(e.g., hospitals, clinics, some emergency response settings; clinics in 
schools or correctional facilities); and healthcare-related settings 
where there is increased potential for exposure to infectious agents 
due to the populations being served or the materials being handled 
(e.g., drug treatment programs; laboratories that handle potentially 
infectious biological materials; medical examiners' and coroners' 
offices; and mortuaries). The purpose of this Request for Information 
(RFI) is to gather additional information on occupational exposure to 
infectious agents, how occupational exposure is being mitigated, and 
other types of work settings where there may be an increased risk of 
exposure. It should be noted that bloodborne pathogens (e.g., HIV, 
hepatitis B), are already covered by OSHA's Bloodborne Pathogens 
standard (Sec.  1910.1030) and are not included in this RFI.
    The primary routes of infectious disease transmission in US 
healthcare settings are contact, droplet, and airborne. Contact 
transmission can be sub-divided into direct and indirect contact.\4\ 
Direct contact transmission involves physical contact between an 
infected person and another person, and the physical transfer of 
microorganisms (e.g., direct skin-to-skin contact). Indirect contact 
transmission occurs in situations where the physical transfer of 
microorganisms to a person comes from contact with a contaminated 
surface (e.g., contaminated environmental surfaces, such as a door 
knob, inadequately cleaned patient-care instruments or equipment, such 
as an examination table or patient bed).
    Droplets containing microorganisms are generated when an infected 
person coughs, sneezes, or talks, or during certain medical procedures, 
such as suctioning or endotracheal intubation. Transmission occurs when 
droplets generated in this way come into direct contact with the 
mucosal surfaces of the eyes, nose, or mouth of a susceptible 
individual.\5\ Droplets are too large to be airborne for long periods 
of time, and droplet transmission does not occur through the air over 
long distances. However, some of the droplets expelled by the infected 
patient will desiccate (dry out) very quickly (less than 1-2 seconds) 
and form what are called droplet nuclei (residue from evaporated 
droplets). These small particles can remain suspended in air for long 
periods of time and travel significantly longer distances.
    Airborne transmission occurs when infectious droplet nuclei or 
particles containing infectious agents that remain suspended in air, 
are inhaled, enter the respiratory tract and cause infection.\6\ Since 
air currents can disperse these droplet nuclei or particles over long 
distances, airborne transmission does not require face-to-face contact 
with an infected individual. Airborne transmission only applies to 
those organisms that are capable of surviving and retaining infectivity 
for relatively long periods of time in airborne droplet nuclei or 
particles. Only a limited number of diseases are transmissible via the 
airborne route.
    The major goal of infection control (IC) is to prevent transmission 
of infectious diseases to patients and HCWs. This fundamental approach 
is set forth in the guidelines of the Department of Health and Human 
Services (HHS) Centers for Disease Control and Prevention's (CDC) 
Healthcare Infection Control Practices Advisory Committee (HICPAC), a 
Federal advisory committee to CDC on the practice of health care 
infection control in U.S. healthcare facilities. The HICPAC guidelines 
include:
Identification and isolation of infectious cases; immunizations for 
vaccine-preventable diseases; standard and transmission-based 
precautions; training; personal protective equipment (PPE); management 
of HCWs' risk of exposure to infected persons, including post-exposure 
prophylaxis; and work restrictions for exposed or infected healthcare 
personnel.\7\
    These recommendations have been endorsed by professional 
associations such as the Association for Professionals in Infection 
Control and Epidemiology (APIC),\8\ the Society for Healthcare 
Epidemiology of America (SHEA),\9\ and the Association of periOperative 
Registered Nurses (AORN).\10\ OSHA is soliciting comment through this 
RFI on any other strategies that might be applied within healthcare or 
healthcare-related work settings to mitigate the risk of occupationally 
transmitted infectious diseases.
    While the CDC/HICPAC guidelines present the recommended practices 
for reducing the risk of infectious disease transmission to patients 
and HCWs, the guidelines are non-mandatory. However, Centers for 
Medicare and Medicaid Services (CMS) mandates that in order for 
hospitals and other providers to receive certification and 
reimbursement through Medicare or Medicaid, the "facility must 
establish and maintain an Infection Control Program designed to provide 
a safe, sanitary and comfortable environment and to help prevent the 
development and transmission of disease and infection." \11\ 
Similarly, the Joint Commission (formerly called the Joint Commission 
on Accreditation of Healthcare Organizations), a private not-for-profit 
organization that evaluates and accredits more than 17,000 healthcare 
organizations and programs in the United States, requires an effective 
Infection Prevention and Control Plan for accreditation.\12\
    CDC/HICPAC has stated that "adherence to recommended infection 
control practices decreases transmission of infectious agents in 
healthcare settings." \13\ While the infection control guidelines and 
requirements are widely recognized, day-to-day compliance, surveillance 
and oversight is left to each individual employer. Due to the continued 
prevalence of healthcare-associated infections (HAIs), particularly 
among patients,\14\ and the emergence of new infectious diseases that 
affect both patients and HCWs [e.g., severe acute respiratory syndrome 
(SARS), 2009 H1N1 pandemic influenza], compliance with routine 
infection control procedures is an increasingly important issue.
    The lack of adherence to voluntary infection control procedures is 
of particular interest to OSHA. CDC/HICPAC states that "several 
observational studies have shown limited adherence to recommended 
practices by healthcare personnel." \15\ It should be noted that these 
were small case studies which were not designed to be representative of 
healthcare settings in general. CDC/HICPAC has also noted that HCWs 
generally reported greater self-adherence to infection control 
practices than was actually reported in observational studies. Observed 
adherence to universal precautions (now part of standard precautions) 
ranged from 43% to 89%, with even greater variability reported for 
certain recommended infection control practices (e.g., glove use).\16\
    The World Health Organization (WHO) recognized the lack of 
compliance with hand hygiene and launched the First Global Patient 
Safety Challenge to achieve improvement in hand hygiene worldwide. In 
2009, WHO issued hand hygiene guidelines that were based upon a 
thorough review of hundreds of manuscripts that dealt with the negative 
impact of non-compliance with hand hygiene on the transmission of 
infectious diseases in healthcare settings.\17\ A second review that 
examined the results of 20 hospital-based studies published between 
1977 and 2008, concluded that despite study limitations, most studies 
showed a temporal relation between improved hand hygiene practices and 
reduced infection and cross-contamination rates.\18\
    A study of adherence to CDC recommended respiratory infection 
control practices examined 653 healthcare workers in primary care 
clinics and emergency departments of five medical centers and found 
significant gaps in compliance. There were shortcomings in overall 
personal and institutional use of CDC recommended practices, including 
deficiencies in posted alerts, patient masking and separation, hand 
hygiene, PPE use, staff training, and written procedures.\19\ Another 
study, published in 2009, surveyed nurses and doctors from five medical 
facilities and documented the lack of compliance with both hand hygiene 
and respiratory protection guidelines. Although not necessarily 
representative of, or generalizable to, the healthcare industry, it is 
of interest that of those doctors that responded to the survey, only 8% 
of 177 reported using recommended respiratory protection and only 33% 
of 156 reported practicing recommended hand hygiene. In addition, of 
those nurses that responded to the survey, only 25% of 249 reported 
practicing appropriate respiratory precautions and only 43% of 266 
reported practicing recommended hand hygiene measures.\20\
    In another recent study 292 HCWs were surveyed about their use of 
PPE for protection against influenza. These HCWs consisted of internal 
medicine house-staff, pulmonary/critical care fellows, faculty, 
respiratory therapists and nurses working in four ICU's in two large 
hospitals. The study found that only 63% of the HCWs surveyed were able 
to correctly identify appropriate PPE for influenza. The study's 
authors stated that of the respondents "nearly 40% of HCWs reported 
poor adherence with influenza PPE, and 53% reported that their 
colleagues often forget to use appropriate PPE." \21\ The CDC 
initiated a similar investigation of possible occupationally-acquired 
2009 H1N1 pandemic influenza, which was published in the April-May 2009 
MMWR. In response to a solicitation from CDC, State health departments 
reported 48 cases of confirmed or probable cases of H1N1 infection in 
HCWs. Of the 48 cases, information on PPE use was available for 11 of 
the HCWs who were deemed to have probable or possible acquisition from 
a patient. Of these 11 HCWs who were infected, only 3 reported always 
using either a surgical mask or an N95 respirator when appropriate and 
none reported always following standard precautions (e.g., use of 
gloves, gown, facemask) and airborne precautions (e.g., use of a 
respirator).\22\
    In its revised 2007 guidelines, CDC/HICPAC noted that "a recent 
review of the literature concluded that variations in organizational 
factors (e.g., safety culture, policies and procedures, education and 
training) and individual factors (e.g., knowledge, perceptions of risk, 
past experience) were determinants of adherence to infection control 
guidelines for protection against SARS and other respiratory 
pathogens." \23\
    Several studies have found organizational factors to be the most 
significant predictor of safe work behaviors. A study by Gershon et al. 
of 1716 hospital-based HCWs, at three regional hospitals, found that 
those who perceived that their institution had a strong commitment to 
safety were almost three times more likely to be compliant with 
standard precautions than those who did not.\24\ Similar results were 
found when a group of 350 HCWs from 28 State correctional facilities 
were surveyed.\25\ In addition, a series of studies demonstrated that 
interventions targeted at improving organizational support for worker 
safety and health, resulted in enhanced compliance with standard
 precautions. These studies were: a survey of 789 hospital-based HCWs
 at a large regional research medical enter; a survey of 452 nurses
c employed at one large medical center; a review of behavioral 
interventions to improve infection control practices;
a survey of 1135 HCWs at one large teaching hospital; and 
finally, a survey of 742 nurses at a 900-bed urban teaching 
hospital.26 27 28 29 30 A study by Nichol et al sent 400 
surveys to nurses in nine nursing units from two urban hospitals. Of 
these surveys, 177 were returned with responses. The study found that 
nurses used recommended facial protection (e.g., respirators, surgical 
masks, and eye/face protection) when they felt that management made 
health and safety a high priority, took all reasonable steps to 
minimize hazards, encouraged employees' involvement in health and 
safety issues, and actively worked to protect employees.\31\ Other 
studies in industrial settings have shown that safety culture has an 
important influence on implementation of training skills and 
knowledge.32 33
    The lack of compliance with recommended infection control practices 
is also noted by the Institute of Medicine (IOM), a Congressionally-
chartered independent, nonprofit organization that provides unbiased 
and authoritative advice to decision makers and the public. In 2009, 
the IOM issued a report entitled, Respiratory protection for healthcare 
workers in the workplace against novel H1N1 influenza A: A letter 
report. The report was requested by both CDC and OSHA, and concluded 
that:

   * * * although workers are aware of expert guidance and the risk 
they face, they often do not wear PPE when faced with conditions 
requiring its use. Such noncompliance is also seen in low rates of 
hand hygiene and use of gloves, respirators, and eye protection. To 
improve the compliance rates and thereby improve worker protection, 
a "culture of safety" for workers must be established in all 
healthcare organizations evidenced by senior leadership 
commitment." \34\

    The relationship between safety culture and compliance with 
recommended infection control guidance in some portions of the 
healthcare sector is not a newly recognized issue. A 1999 IOM report on 
medical errors in the healthcare sector emphasized the pivotal role of 
system failures and the benefits of a strong safety culture in the 
prevention of such errors. The report notes that a safety culture is 
created through: (1) The actions management takes to improve both 
patient and worker safety; (2) worker participation in safety planning; 
(3) the availability of appropriate protective equipment; (4) the 
influence of group norms regarding acceptable safety practices; and (5) 
the organization's socialization process for new personnel.\35\ 
Similarly, CDC/HICPAC has noted that "several hospital-based studies 
have linked measures of safety culture with both employee adherence to 
safe practices and reduced exposures to blood and body fluids." \36\ 
This evidence was cited by CDC/HICPAC as one of the primary reasons for 
updating its guidance in 2007.\37\ CDC/HICPAC noted that organizational 
characteristics, including safety culture, influence healthcare 
personnel adherence to recommended infection control practices and, 
therefore, are important factors in preventing transmission of 
infectious agents. CDC/HICPAC further emphasized the need for 
administrative involvement in the development and support of IC 
programs.
    Noncompliance with recommended infection control practices (e.g., 
hand hygiene, and proper use of gloves, facemasks, and respirators) 
increases the risk of transmission of infectious diseases among 
patients and workers.19 31 38 HHS notes that HAIs are among 
the leading causes of death in the United States, accounting for an 
estimated 1.7 million infections and 99,000 associated deaths in 
2002.\39\ The 2007 CDC/HICPAC guidelines note that infectious agents 
are also transmitted from HCWs to patients.\40\
    More specifically, poor infection control practices have been 
implicated in both acquisition and transmission of methicillin-
resistant Staphylococcus aureus (MRSA) by healthcare personnel.\41\ 
Other studies have documented the nosocomial (hospital-acquired) 
transmission of adenovirus from patients to HCWs 42 43; 
invasive Group A Strep (GAS) from a patient to an HCW \44\; Clostridium 
difficile infection from a patient to a nurse in an oncology ward \45\; 
and a norovirus outbreak in HCWs in a hospital.\46\ Additionally, CDC/
HICPAC has documented the occupational transmission of influenza in 
hospitals and nursing homes.\47\ OSHA previously documented 
occupational exposure to tuberculosis (TB) in its notice "Occupational 
Exposure to Tuberculosis; Proposed Rule" (62 FR 54160-54308; October 
17, 1997). Additionally, an investigation of the 2003 SARS outbreak in 
Toronto, Canada, described the nosocomial transmission of SARS at a 
hospital. The investigation found that 42.5% of the cases occurred 
among hospital employees.\48\
    Although HCW infections have been documented, published data on the 
prevalence of these infections is limited. Recently, the National 
Institute for Occupational Safety and Health (NIOSH) noted that a lack 
of occupational data in existing healthcare surveillance systems made 
tracking illnesses among HCWs difficult.\49\ The healthcare sector puts 
forth substantial effort to track patient infections, but does not 
appear to match that effort with a systematic means for tracking 
occupationally acquired worker infections. A weak culture of worker 
safety in this sector may be a contributing factor to this issue.

B. History of Occupational Safety and Health Regulations Addressing 
Protection of Workers From Infectious Diseases

    OSHA's past efforts to protect workers against occupationally 
acquired infectious diseases include the Bloodborne Pathogens standard 
(Sec.  1910.1030), promulgated in 1991. That standard requires a 
comprehensive programmatic approach to controlling transmission of 
bloodborne diseases. Following its promulgation, the incidence of 
Hepatitis B in HCWs dropped from more than 100 cases per 100,000 HCWs 
in 1991 to only 9.1 cases per 100,000 HCWs in 1995.\50\ The standard 
was revised in 2001 in response to the Needlestick Safety and 
Prevention Act, Pub. L. 106-430. In general, the revisions require 
employers to evaluate and use safer medical devices (e.g., needleless 
devices, sharps with engineered sharps injury protections), and to 
establish and maintain a sharps injury log for recording percutaneous 
injuries from contaminated sharps.
    As a result of a marked increase in tuberculosis (TB) during the 
early 1990s, which included worker infections, OSHA initiated action to 
address occupational exposure to TB. A standard was proposed, but was 
later withdrawn. In part, the proposal was withdrawn because of 
healthcare facilities' increased adherence to CDC's TB guidelines and 
the subsequent decline in TB infection rates.\51\ To assure continued 
protection of workers, OSHA addresses occupational exposure to TB 
through its TB compliance directive.\52\ The directive utilizes the CDC 
guidelines as the recognized means for controlling TB exposure. When 
OSHA determines that a TB hazard exists in a facility, exposure control 
deficiencies may be cited under existing OSHA standards [e.g., the 
Respiratory Protection standard (Sec.  1910.134)] and the General Duty Clause 
[Section 5(a)(1) of the Occupational Safety and Health Act of 1970, 
Pub. L. 91-596 (OSH Act)]. The General Duty Clause requires employers 
to "* * * furnish to each of his employees employment and a place of 
employment which are free from recognized hazards that are causing or 
are likely to cause death or serious physical harm to his employees."
    California-OSHA (Cal-OSHA) recently promulgated an Aerosol 
Transmissible Diseases (ATD) Standard \53\ to protect workers from 
exposure to infectious agents transmitted via the droplet or airborne 
routes. Following Federal OSHA's withdrawal of the TB proposal, Cal-
OSHA developed its standard in response to concerns about TB, the 2003 
SARS epidemic, and a potential influenza pandemic. The standard 
significantly expands protection of California workers against aerosol 
transmissible diseases (this term, as defined by Cal-OSHA, encompasses 
those diseases that can be transmitted by the droplet or airborne 
routes). It should be noted that the standard does not deal with 
occupational exposure to infectious agents that are transmitted 
primarily via the contact route (e.g., MRSA, Group A strep, and 
noroviruses).
    Existing OSHA standards that may be applicable to controlling 
occupational exposure to infectious agents, other than the bloodborne 
pathogens standard, include: The Respiratory Protection standard (Sec.  
1910.134); the Personal Protective Equipment standard (Sec.  1910.132); 
and the Specifications for Accident Prevention Signs and Tags standard 
(Sec.  1910.145). OSHA is seeking information through this RFI on 
whether or not its existing standards and the voluntary guidelines 
issued by other organizations are effectively protecting workers from 
occupational exposure to infectious agents. If not, OSHA seeks comment 
on what measures might be appropriate for the Agency to take to protect 
workers against infectious diseases (e.g., development of a proposed 
standard, issuance of guidelines, or other alternatives).

C. Summary

    In summary, as a result of several factors raised in the preceding 
discussion, OSHA is seeking additional information to more fully 
evaluate worker exposures to infectious agents in healthcare and 
healthcare-related settings. We are particularly interested in 
additional data regarding indications in some studies that transmission 
of infectious diseases to both patients and HCWs may be occurring as a 
result of incomplete adherence to voluntary infection control measures 
in traditional healthcare facilities. Another concern is the movement 
of healthcare delivery from the traditional hospital setting, with its 
greater infrastructure and resources to effectively implement infection 
control measures, into more diverse and smaller workplace settings with 
less infrastructure and fewer resources, but with an expanding worker 
population.
    Consequently, the Agency is seeking information to assist in its 
deliberation on these issues. OSHA is interested in more accurately 
characterizing the nature and extent of occupationally-acquired 
infectious diseases and the strategies that are currently being used to 
mitigate the risk of occupational exposure to infectious agents in 
healthcare and healthcare-related settings, including patient and non-
patient settings and sites where healthcare is embedded within non-
healthcare settings such as clinics in schools and correctional 
facilities. The information being sought includes: the types of 
facilities and workers incurring this risk; successful employer 
infection control programs; control methodologies being utilized 
(including engineering, administrative, and work practice controls, and 
the use of appropriate personal protective equipment); medical 
surveillance programs; and training programs. The information received 
in response to this notice will be carefully reviewed and will assist 
OSHA in determining the effectiveness of approaches currently being 
used to eliminate and minimize occupational exposure to infectious 
agents. Based upon its analysis of this information, OSHA will 
determine what action, if any, the Agency may take to address these 
issues.

II. Request for Data, Information and Comments

A. General

    The following general information will assist OSHA in more fully 
understanding each commenter's submissions and the possible differences 
in their approaches to infection control. The answers to the questions 
will also help OSHA understand the risk of workers contracting various 
infectious diseases in different types of workplaces.

    Note: Diseases spread through bloodborne pathogens are not 
encompassed by this RFI since a specific OSHA standard (Bloodborne 
Pathogens, Sec.  1910.1030) addresses those diseases. OSHA 
encourages those with experience in non-traditional or non-
healthcare work settings to respond to these questions.

    1. Since healthcare is provided in a wide variety of settings (as 
previously described), OSHA is interested in being able to sort the 
responses received by the characteristics of the workplace about which 
each responding entity is providing information. As such, please 
describe the characteristics of the workplace to which you are 
referring. For example: type of workplace (e.g., hospital, long-term 
care, physician/dentist office, emergency medical services); size 
(e.g., number of hospital beds, number of residents, average number of 
patients/clients); total number of employees (both direct care and 
administrative support).
    2. While OSHA is primarily concerned about worker exposure to 
infectious agents in traditional healthcare settings, the Agency 
recognizes that there are other settings where healthcare may be 
provided and where occupational exposure to infectious agents may be a 
significant concern (e.g., drug treatment facilities, home health 
services, prison clinics, school clinics, and laboratories that handle 
potentially infectious biological materials). Please describe any other 
work settings with an increased risk for occupational exposure to 
infectious agents that OSHA should consider, including why they should 
be considered. Please describe the nature and extent to which 
occupational exposure to infectious agents is a significant concern. 
For example, to which infectious agents are workers in these settings 
exposed and how often are they exposed? Please describe any infection 
control measures that can be or are being used in these settings.
    3. One of the most important steps in determining how to 
effectively protect workers from infectious diseases is identifying who 
is at risk of exposure. What recommendations do you have for how to 
determine which employees are potentially exposed to contact, droplet, 
and airborne transmissible diseases in the type of workplace about 
which you are responding? How many of your total workers have a risk of 
exposure to such diseases during the performance of their job duties? 
What proportion of your workforce does this represent? What are the job 
titles or classification(s) of these workers? What are the job duties 
of these workers? To which diseases are they exposed?
    4. Workplaces vary in the types of infectious diseases and the 
number of infected individuals encountered. OSHA is interested in the 
types of diseases that your workplace encounters and how often they are 
encountered. Please describe your workplace's experience with 
infectious diseases over the past ten years (e.g., which diseases, how often).
    5. OSHA is interested in data and information that will further 
assist in characterizing workers' occupational exposure to contact, 
droplet, and airborne transmissible infectious diseases.
    (a) OSHA encourages the submission of your workplace or your 
industry's experience with these diseases and the impact of infectious 
diseases on your workers (e.g., type and number of exposure incidents, 
occupationally-acquired infectious diseases, days of work missed, and 
fatalities).
    (b) Please provide information about any database that collects and 
aggregates data on occupationally-acquired infectious diseases (e.g., 
Federal, State, provider network, or academic).
    (c) Please provide any additional information, including peer-
reviewed studies, which addresses occupational exposure to infectious 
agents that you think OSHA should consider.
    6. Infection control (IC) programs are currently the primary means 
of controlling occupational exposure to infectious agents. However, 
these programs are largely voluntary. OSHA is particularly interested 
in case studies that highlight experience in the implementation and 
effectiveness of IC programs in protecting workers against infectious 
diseases (e.g., the extent to which employers are fully implementing 
and consistently following their written IC programs). For example, has 
your workplace had instances where a significant increase in infections 
(among either patients or workers) required more rigorous 
implementation of your IC program? If so, please describe any factors 
that contributed to the increase and what steps your workplace took to 
address the situation. Please provide any studies that demonstrate the 
difference in infection rates between situations where the IC program 
had lapsed and situations where rigorous implementation of control 
measures was instituted.
    7. While OSHA has a Bloodborne Pathogens standard (Sec.  
1910.1030), the Agency does not have a comprehensive standard that 
addresses occupational exposure to contact, droplet, and airborne 
transmissible diseases. The Agency has other standards [(e.g., 
Respiratory Protection (Sec.  1910.134) and General Personal Protective 
Equipment (Sec.  1910.132)] that may apply and, in some situations, 
Section 5(a)(1) of the OSH Act (the General Duty Clause) would apply. 
OSHA is interested in commenters' insights regarding the adequacy of 
existing OSHA requirements to protect workers against occupational 
exposure to infectious agents.
    8. California OSHA recently issued a standard for occupational 
exposure to "Aerosol" Transmissible Diseases that covers infectious 
diseases transmitted through the airborne and droplet routes. IC 
programs that are established in most healthcare settings address 
exposure to contact, droplet, and airborne transmissible diseases. 
Please explain whether the Agency's deliberations on occupational 
exposure to infectious diseases should focus on only droplet and 
airborne transmission or if contact transmissible diseases should also 
be included.
    9. If the Agency pursues rulemaking and promulgates a standard, 
jurisdictions with OSHA-approved State plans will be required to cover 
workers who OSHA determines are at occupational risk for exposure to 
infectious agents, including public employees. State and local 
governments are defined very broadly, and would typically include such 
entities as a university hospital associated with a State university as 
well as public hospitals and health clinics. What public sector 
healthcare or healthcare-related workers are at increased risk for 
occupational exposure to infectious agents? Please describe conditions 
unique to any of these occupations that are not seen in the private 
sector. Please describe any other issues specific to OSHA-approved 
State plans that the Agency should consider.

B. Infection Prevention and Control Plan

    10. CDC/HICPAC's 2007 Guideline for Isolation Precautions: 
Preventing Transmission of Infectious Agents in Healthcare Settings 
recommends an IC program for addressing the transmission of airborne 
and other infectious diseases. In certain settings, the Center for 
Medicare and Medicaid Services (CMS) and the Joint Commission require 
that healthcare facilities have such programs.
    (a) If you are subject to the CMS or Joint Commission requirements 
or otherwise have an IC program, please provide information on the 
elements of this program (e.g., early identification of infectious 
patients, implementation of transmission-based control measures, HCW 
training) and how the program works.
    (b) If you are not subject to these requirements and do not have an 
IC program, how does your workplace address preventing contact, droplet 
and airborne transmissible infectious diseases?
    11. In most cases, an IC program is managed by an infection control 
preventionist or other designated person. For example, the CDC/HICPAC 
guidelines recommend that the IC program be managed by individuals with 
training in infection control. Who manages your program? What 
percentage of this individual's time is spent managing the IC program?
    12. For the IC program(s) established in your workplace, please 
describe, in detail, the resource requirements and associated costs, if 
available, expended to initiate the program(s) and conduct the 
program(s) annually. Please estimate, in percentage terms where 
possible, the extent to which the components or elements in your 
program(s) are typical of those practiced throughout your industry.
    13. In your industry, for the IC programs established in your 
workplace or for IC programs in other workplaces of which you are 
aware, are there any components or features that may present economic 
difficulties to small businesses? Please describe and characterize in 
detail these components and why they might present difficulties for 
small businesses.
    14. Periodic evaluation of IC program effectiveness is recommended 
by CDC/HICPAC and required by the Joint Commission and CMS for most 
types of facilities under their jurisdiction. Please describe how your 
workplace or industry evaluates the effectiveness of its IC program, 
including the methods and criteria used. How often does your workplace 
evaluate its program? Please describe the results your program has 
achieved (e.g., if there has been a decrease in patient and/or worker 
infections). Please describe any specific problems and/or successes 
that have been encountered in the implementation and operation of the 
program.
    15. Most peer-reviewed literature evaluating IC programs focuses on 
protecting patients from contracting HAIs. While this body of evidence 
can be an indicator of worker exposure, OSHA is seeking data that more 
specifically address the occupational risk to workers. If your 
workplace has a system for tracking worker exposures or infections that 
may have been occupationally acquired, please share with us the 
following information:
    (a) A description of the tracking system and how it works;
    (b) The types of infection diseases encountered in your workplace 
and the number of exposures and/or infections tracked;
    (c) Exposure/infection rates; and
    (d) Any trend data.
C. Methods of Control
    16. If your workplace has a process for early identification of 
patients or clients who may have an infectious disease, please explain 
how your workplace conveys information to workers about individuals who 
are confirmed or suspected of being infectious, so that proper 
precautions can be implemented. Please describe the degree of success 
with these procedures and whether you think that such procedures are 
likely to be effective in other healthcare or healthcare-related 
settings.
    17. CDC/HICPAC, CMS, and the Joint Commission provide a variety of 
approaches that employers can implement to reduce or eliminate workers' 
exposure to infectious agents. For example, a well-structured IC 
program can include: immunizations for vaccine-preventable diseases, 
isolation precautions to prevent exposures to infectious agents, 
training, personal protective equipment, management of workers' risk of 
exposure to infected persons, including post exposure prophylaxis, and 
work restrictions for exposed or infected personnel. Please describe 
the types of problems/obstacles your workplace or industry encountered 
with implementing specific control measures. Please include a 
discussion of each control measure, the problem/obstacle encountered, 
the affected worker group, and any particularly effective solutions 
your workplace or industry has implemented to address the obstacle/
problem.
    18. When developing and implementing infection control measures in 
your workplace, are there any recommended controls that you have found 
to be ineffective or unnecessary in controlling infectious diseases? If 
so, please explain how you arrived at this conclusion.
    19. Airborne infection isolation rooms (AIIRs) are recommended as 
one aspect of controlling certain airborne transmitted diseases (e.g., 
TB, SARS). OSHA recognizes that most workplaces outside of hospitals do 
not have an AIIR and will transfer persons requiring airborne 
precautions to a facility with the necessary capabilities. If your 
workplace provides healthcare or other services to individuals 
requiring airborne precautions, how many of these patients/individuals 
has your workplace encountered in each of the last ten years? If 
individuals requiring airborne precautions must be transferred to 
another facility, please describe how your workplace identifies and 
isolates them while they are awaiting transfer. If your workplace 
provides extended care to these individuals (e.g., a hospital), does it 
have sufficient AIIRs to isolate the number of infected individuals 
your workplace has handled at any one time? If not, how does your 
facility provide alternate means of isolation and how many additional 
AIIRs would be necessary to fully accommodate your normal patient load? 
Please describe how your workplace plans to address surge capacity in 
the event of an outbreak, epidemic, or pandemic. Please provide any 
additional information, including peer-reviewed studies, which 
addresses issues relevant to the use of AIIRs in your workplace or 
industry.
    20. CDC/HICPAC's 2007 Guideline for Isolation Precautions: 
Preventing Transmission of Infectious Agents in Healthcare Settings 
addresses the need for a safety culture and its role in improving a 
workplace's IC program (e.g., worker adherence to safe work practices). 
Please describe the policies and actions undertaken in your workplace 
or industry to develop and maintain a culture of worker safety. Please 
describe any means that have been particularly effective in fostering a 
safety culture and any problems or obstacles that have been encountered 
in developing and/or maintaining the safety culture.
    21. Poor adherence to infection control measures (e.g., failure to 
use necessary PPE or to follow recommended hand hygiene practices) can 
be one indicator of the breakdown of an IC program. Please describe 
what actions have been undertaken in your workplace or industry to 
assess and enforce adherence to infection control measures. What 
obstacles has your workplace encountered in maintaining adherence and 
are there any particularly successful ways you have found to maintain 
adherence (e.g., training initiatives, worker incentives)? Please 
discuss any underlying factors that you feel may affect non-compliance 
with current infection control guidelines and standards in your 
facility.
    22. The use of proper PPE is an essential component of an effective 
IC program. For example, CDC/HICPAC recommends that facemasks (e.g., 
surgical masks) be worn by workers when droplet precautions are 
implemented and respirators be worn under certain circumstances when 
airborne precautions are in place. Please describe how your workplace 
determines when a facemask (e.g., surgical mask) is used for worker 
protection and when a respirator is used for worker protection. How 
does your workplace determine which employees use a facemask and which 
use a respirator? If your workplace uses different types of 
respirators, please describe what types and when they are used.
    23. NIOSH regulates the testing and certification of respiratory 
protective equipment, has established minimum performance standards, 
and conducts independent testing and verification of all respirators 
prior to certification. The Food and Drug Administration (FDA) approval 
process for facemasks does not have established minimum performance 
standards and allows manufacturer submitted data. As noted in a 2009 
IOM report,\54\ a 2008 study that examined the filter performance of 
nine different types of facemasks using the sodium chloride NIOSH 
challenge test, found wide variation in penetration (4 percent to 90 
percent) of smaller aerosol particles.\55\ Therefore, the protective 
properties of different manufacturers' facemasks may vary. Is there a 
need for a more rigorous certification/approval process for facemasks 
and additional independent verification of the personal protective 
properties of these devices?
    24. Some HCWs have medical conditions or are receiving treatments 
that impair their ability to resist infection. These HCWs may be unable 
to develop protective immune responses after vaccination. What is your 
workplace or industry doing to educate its workers about these 
conditions? What approaches are being used or should be used to address 
the special needs of HCWs with these conditions?

D. Vaccination and Post-Exposure Prophylaxis

    25. In the Bloodborne Pathogens standard (Sec.  1910.1030), OSHA 
requires that hepatitis B vaccinations be made available to employees 
occupationally exposed to blood or other body fluids. It should be 
noted that while employers are required to offer the vaccine, employees 
are permitted to decline it. CDC/ACIP recommends a number of other 
vaccines for various groups of HCWs including: influenza (both seasonal 
and the 2009 H1N1); measles, mumps, rubella (MMR); varicella; tetanus, 
diphtheria, pertussis (Td/Tdap); and meningococcal vaccines. What 
vaccinations, other than hepatitis B, do you consider to be necessary 
to protect workers from occupational exposure to infectious agents? Who 
should receive these vaccinations, and why? Does your workplace offer 
vaccines other than the hepatitis B vaccine to workers and how do you 
determine who is offered these vaccines?
    26. The Bloodborne Pathogens standard (Sec.  1910.1030) requires 
that employers follow certain administrative and recordkeeping 
procedures (e.g., signing a declination statement; placing
an employee's vaccination status in his/her medical record). Does your 
workplace or industry use similar administrative and recordkeeping 
procedures for vaccines other than hepatitis B? If not, please describe 
what administrative and recordkeeping procedures are or should be used.
    27. Post-exposure prophylaxis (PEP) and evaluation for bloodborne 
pathogen exposures, such as hepatitis B and HIV, are addressed in the 
Bloodborne Pathogens standard [Sec.  1910.1030(f)]. OSHA is interested 
in post-exposure evaluation and PEP for other infectious diseases. 
Please describe the current PEP and evaluation practices in your 
workplace. For what infectious agent exposures should workers be 
provided with PEP and/or evaluation? Please describe the disease, its 
associated PEP, and the PEP efficacy.
    28. In some instances, a vaccine may be available for a disease but 
a worker may decline vaccination. Please describe procedures in your 
workplace that ensure workers who have declined vaccination have access 
to necessary PEP.
    29. In order to appropriately evaluate the health status of a 
worker, some basic health information is needed. CDC/HICPAC recommends 
a personnel health service program for infection control that includes 
a number of components including: pre-placement evaluations, evaluation 
and treatment of exposure-related illnesses, and work restriction or 
work-exclusion policies for exposed HCWs. OSHA is interested in the 
prevalence, content and efficacy of such personnel health service 
programs.
    (a) What should be included in a pre-placement medical evaluation 
for a worker who will be exposed to infectious agents? Please describe 
the possible components of the medical history and physical exam and 
specific tests (e.g., TB skin test, spirometry, blood tests). How are 
pre-placement medical evaluations of workers addressed in your 
workplace? What do these evaluations include? If pre-placement medical 
evaluations are used in your workplace, have they been effective, and 
what metrics are used to evaluate effectiveness? Give the rationale, 
including references if available.
    (b) What type of ongoing medical surveillance or periodic medical 
evaluations should be provided for exposed workers? Please describe the 
possible components of such surveillance or evaluations. How often 
should periodic medical evaluations be conducted? In what situations 
should medical evaluations or surveillance be performed (e.g., return-
to-work, fitness for duty)? How are periodic medical evaluations 
addressed in your workplace?
    (c) In your State, are there State laws that apply to pre-placement 
and periodic medical evaluations of exposed workers? If so, what are 
they?
    (d) Please describe the administrative procedures used by your 
workplace to evaluate and treat workers who have been occupationally 
exposed and/or infected (e.g., who do they notify of the exposure/
infection). How are the costs for treatment and follow-up (e.g., visits 
to physician, lab tests) handled in your workplace? If a worker is put 
on restrictions or excluded from work due to a work-related infectious 
exposure or illness, how are the worker's salary, benefits, and 
seniority handled by your workplace?

E. Communication of Hazards

    30. Training is generally considered a necessary component of an 
effective IC program in order to assure that workers understand the 
hazards they are exposed to and the proper methods of protection. 
Please describe how your workplace assures that workers are adequately 
trained in the use of infection control measures, including how your 
workplace assesses if a worker has been adequately trained. Please 
describe the contribution of training and education to improving 
adherence to your IC program. Please describe the format used by your 
workplace to conduct training (e.g., computer-based, written material, 
interactive classes, hands-on practice, other) and whether you have 
found some more effective than others. Please describe what role, if 
any, knowledge and/or competency assessment plays in your workplace 
training program.
    31. Both initial and periodic worker training are recognized as 
important components of an effective IC program. Initial training 
provides information that workers need to protect themselves against 
exposures to hazards while periodic training refreshes worker 
knowledge, reinforces the importance of the IC program and provides a 
means of introducing new information and procedures.
    (a) What information should be included in initial training for 
workers who may be exposed to infectious agents? What is the best 
format for providing initial training to these workers (e.g., 
specifying a minimum number of hours of training, specifying training 
content based on job tasks, specifying that training be adequate to 
demonstrate specified competencies, by a combination of these methods 
or by some other method)?
    (b) How frequently does your workplace provide workers with 
refresher training on its IC program? What information should be 
included in periodic refresher training for workers who may be exposed 
to infectious agents? What is the best format for providing periodic 
training to these workers (e.g., specifying a minimum number of hours 
of training, specifying training content based on job tasks, specifying 
that training be adequate to demonstrate specified competencies, by a 
combination of these methods or by some other method)? Should refresher 
training be provided based on lack of competency, or be provided at 
regular time intervals regardless of demonstrated competency?

F. Recordkeeping

    32. Please describe the worker health surveillance system used in 
your workplace. Does the system include tracking of occupational 
exposures to infectious agents and/or occupationally-acquired 
infectious diseases? Please describe the procedures used by your 
workplace to determine whether an infectious disease is considered to 
have been occupationally-acquired. How is the worker health 
surveillance information collected under the system used in your IC 
program? Please describe the factors that affect the successful 
implementation of such surveillance systems.
    33. The OSHA requirements for recording and reporting occupational 
injuries and illnesses contain an exemption for the common cold and flu 
(Sec.  1904.5(b)(2)(viii)). However, the Agency has determined that, if 
certain criteria are met, occupationally-acquired 2009 H1N1 pandemic 
influenza is recordable (OSHA Directive CPL-02-02-075). As OSHA more 
broadly considers the issue of occupational exposure to infectious 
agents, what are the implications, if any, for the Agency's existing 
recording and reporting requirements under Sec.  1904?

G. Economic Impacts and Benefits

    As part of the Agency's consideration of occupational exposure to 
infectious agents, OSHA is interested in the costs, economic impacts, 
and benefits of related practices to prevent such exposure. OSHA is 
also interested in the benefits of such practices in terms of reduced 
deaths, illnesses, and compromised operations (i.e., infirm personnel, 
quarantined or disabled units, unexpected reallocation of resources). 
The following questions will provide OSHA with needed economic impact 
and benefits information.
    34. As the Agency considers possible actions to address the 
prevention and control of infectious diseases (e.g., prospective 
standards or guidelines), what are the potential economic impacts 
associated with the promulgation of a standard specific to the hazards 
of infectious diseases? Describe these impacts in terms of benefits 
from the reduction of incidents and illnesses; effects on revenue and 
profit; and any other relevant impact measure. If you have any 
estimates of the costs of controlling infectious disease hazards, 
please provide them.
    35. What changes, if any, in market conditions would reasonably be 
expected to result from issuing a comprehensive infectious diseases 
standard? Describe any changes in market structure or concentration, 
and any effects on services, that would reasonably be expected from 
issuing such a standard.
    36. What are the potential benefits of more widespread compliance 
with infection control guidelines? How can OSHA best assure such 
compliance takes place?

H. Impacts on Small Entities

    As part of the Agency's consideration of occupational exposure to 
infectious agents, OSHA is concerned whether its actions will have a 
significant economic impact on a substantial number of small entities. 
If the Agency pursues development of a standard and the standard has 
such impacts, OSHA is required to develop a regulatory flexibility 
analysis and assemble a Small Business Regulatory Enforcement Fairness 
Act (SBREFA) Panel prior to publishing a proposal. Regardless of the 
significance of the impacts, OSHA seeks ways of minimizing the burdens 
on small businesses consistent with OSHA's statutory and regulatory 
requirements and objectives.
    37. How many, and what type of small firms, or other small 
entities, have infectious disease hazards, and what percentage of their 
industry (NAICS code) do these entities comprise? Please specify the 
types of infectious diseases encountered.
    38. How, and to what extent, would small entities in your industry 
be affected by a potential comprehensive OSHA infectious diseases 
standard regulating occupational exposure to infectious agents? Do 
special circumstances exist that make controlling infectious diseases 
more difficult or more costly for small entities than for large 
entities? Describe these circumstances.

III. Public Participation

    You may submit comments in response to this document by (1) hard 
copy, (2) fax transmission (facsimile), or (3) electronically through 
the Federal Rulemaking Portal. Because of security-related problems, 
there may be a significant delay in the receipt of comments by regular 
mail. Contact the OSHA Docket Office at (202) 693-2350 for information 
about security procedures concerning the delivery of materials by 
express delivery, hand delivery and messenger service.
    All comments and submissions are available for inspection and 
copying at the OSHA Docket Office at the above address. Comments and 
submissions are also available at http://www.regulations.gov. OSHA 
cautions you about submitting personal information such as social 
security numbers and birth dates. Contact the OSHA Docket Office at 
(202) 693-2350 for information about accessing materials in the docket.
    Electronic copies of this Federal Register notice, as well as news 
releases and other relevant documents, are available at OSHA's Web 
page: http://www.osha.gov/index.html.

Authority and Signature

    This document was prepared under the direction of David Michaels, 
Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and 
Health, U.S. Department of Labor. It is issued pursuant to sections 4, 
6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 
653, 655, 657), 29 CFR 1911, and Secretary's Order 5-2007 (72 FR 
31160).

    Signed at Washington, DC, this 30th day of April, 2010.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.

Footnotes:

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Guideline for Isolation Precautions: Preventing Transmission of 
Infectious Agents in Healthcare Settings. Page 15.(http://www.cdc.gov/ncidod/dhqp/pdf/isolation2007.pdf).
    \5\ Ibid. Page 17.
    \6\ Ibid.
    \7\ Bolyard EA et al. and the Healthcare Infection Control 
Practices Advisory Committee. Guideline for Infection Control in 
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    \9\ Ibid.
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    \12\ The Joint Commission: Infection Control Prevention and 
Control. 2009.
    \13\ Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the 
Healthcare Infection Control Practices Advisory Committee, 2007 
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[FR Doc. 2010-10694 Filed 5-5-10; 8:45 am]
BILLING CODE 4510-26-P

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