[Federal Register Volume 66, Number 12 (Thursday, January 18, 2001)]
[Rules and Regulations]
[Pages 5318-5325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1207]



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Part IX





Department of Labor





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Occupational Safety and Health Administration



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29 CFR Part 1910



Occupational Exposure to Bloodborne Pathogens; Needlesticks and Other 
Sharps Injuries; Final Rule

Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / 
Rules and Regulations

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. H370A]
RIN 1218-AB85


Occupational Exposure to Bloodborne Pathogens; Needlestick and 
Other Sharps Injuries; Final Rule

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

ACTION: Final Rule; Request for Comment on the Information Collection 
(Paperwork) Requirements

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SUMMARY: The Occupational Safety and Health Administration is revising 
the Bloodborne Pathogens standard in conformance with the requirements 
of the Needlestick Safety and Prevention Act. This Act directs OSHA to 
revise the Bloodborne Pathogens standard to include new examples in the 
definition of engineering controls along with two new definitions; to 
require that Exposure Control Plans reflect how employers implement new 
developments in control technology; to require employers to solicit 
input from employees responsible for direct patient care in the 
identification, evaluation, and selection of engineering and work 
practice controls; and to require certain employers to establish and 
maintain a log of percutaneous injuries from contaminated sharps.

DATES: Effective Date: The effective date is April 18, 2001. Written 
comments: Written comments on the Information Collection Requirements 
must be submitted on or before March 19, 2001.

ADDRESSES: Copies of materials in the docket may be obtained from the 
OSHA Docket Office, Room N-2625, U.S. Department of Labor, 200 
Constitution Avenue, NW., Washington, DC 20210, Telephone (202) 693-
2350. Referenced documents are included in Docket H370A and are 
identified by the exhibit number indicated.
    Submit written comments on the Information Collection Requirements 
to the Docket Office, Docket No. ICR-0180 (2001), OSHA, U.S. Department 
of Labor, Room N-2625, 200 Constitution Avenue, NW., Washington, DC 
20210; telephone: (202) 693-2350. Commenters may transmit written 
comments of 10 pages or less in length by facsimile to (202) 693-1648.
    In compliance with 28 U.S.C. 2112(a), the Agency designates the 
Associate Solicitor for Occupational Safety and Health, Office of the 
Solicitor, Room S-4004, U.S. Department of Labor, 200 Constitution 
Avenue, NW., Washington, DC 20210, as the recipient of petitions for 
review of the standard.

FOR FURTHER INFORMATION CONTACT: Bonnie Friedman, Director, OSHA Office 
of Public Affairs, Room N-3647, U.S. Department of Labor, 200 
Constitution Avenue, NW., Washington, DC 20210. Telephone: (202) 693-
1999.

SUPPLEMENTARY INFORMATION:

I. Events Leading to the Amended Final Rule

    Blood and other potentially infectious materials have long been 
recognized as a potential threat to the health of employees who are 
exposed to these materials by percutaneous contact (penetration of the 
skin). Injuries from contaminated needles and other sharps have been 
associated with an increased risk of disease from more than 20 
infectious agents (Exs. 3-172GG, 3-274C). The primary agents of concern 
in current occupational settings are the human immunodeficiency virus 
(HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
    To reduce the health risk to workers whose duties involve exposure 
to blood or other potentially infectious materials, OSHA promulgated 
the Bloodborne Pathogens (BBP) standard (29 CFR 1910.1030) on December 
6, 1991 (56 FR 64004). The provisions of the standard were based on the 
Agency's determination that a combination of engineering and work 
practice controls, personal protective equipment, training, medical 
surveillance, hepatitis B vaccination, signs and labels, and other 
requirements would minimize the risk of disease transmission.
    Needlesticks and other percutaneous injuries resulting in exposure 
to blood or other potentially infectious materials continue to be of 
concern due to the high frequency of their occurrence and the severity 
of the health effects associated with exposure. The Centers for Disease 
Control and Prevention has estimated that healthcare workers in 
hospital settings sustain 384,325 percutaneous injuries involving 
contaminated sharps annually (Ex. 5-4). When non-hospital healthcare 
workers are included, the best estimate of the number of percutaneous 
injuries involving contaminated sharps is 590,164 per year (Ex. 3-
172V). When these injuries involve exposure to infectious agents, the 
affected workers are at risk of contracting disease. Workers may also 
suffer from adverse side effects of drugs used for post-exposure 
prophylaxis and from psychological stress due to the threat of 
infection following an exposure incident.
    Since publication of the BBP standard, a wide variety of medical 
devices have been developed to reduce the risk of needlesticks and 
other sharps injuries. These ``safer medical devices'' replace sharps 
with non-needle devices or incorporate safety features designed to 
reduce the likelihood of injury. In a September 9, 1998, Request for 
Information (RFI), OSHA solicited information on occupational exposure 
to bloodborne pathogens due to percutaneous injury (63 FR 48250). Based 
in part on the responses to the RFI, the Agency has pursued an approach 
to minimize the risk of occupational exposure to bloodborne pathogens 
that involves three components. First, the Agency proposed that the 
revised Recordkeeping standard (29 CFR 1904) include a requirement that 
all percutaneous injuries from contaminated needles and other sharps be 
recorded on OSHA logs (61 FR 4030). Second, OSHA issued a revised 
compliance directive for the BBP standard on November 5, 1999, to 
reflect advances made in medical technology and treatment. The 
directive guides OSHA's compliance officers in enforcing the standard 
and ensures that consistent inspection procedures are followed. Third, 
the Agency placed amendment of the bloodborne pathogens standard on its 
regulatory agenda to more effectively address sharps injuries.
    Congress was prompted to take action in response to growing concern 
over bloodborne pathogen exposures from sharps injuries and in response 
to recent technological developments that increase employee protection. 
On November 6, 2000, the Needlestick Safety and Prevention Act was 
signed into law. The Act directs OSHA to revise the BBP standard in 
accordance with specific language included in the Act.

II. Statutory Authority

    On November 6, 2000, President Clinton signed the Needlestick 
Safety and Prevention Act, Pub. L. 106-430. The Act requires OSHA to 
revise the BBP standard within six months of the Act's enactment. To 
facilitate expeditious completion of this directive, Congress 
explicitly exempted OSHA from procedural requirements generally 
attending rulemaking under OSH Act 6(b) and from the procedural 
requirements of the Administrative Procedure Act (5 U.S.C. 500 et 
seq.).

[[Page 5319]]

III. Summary and Explanation

    The revisions to OSHA's BBP standard required under the Needlestick 
Safety and Prevention Act can be broadly categorized into four areas: 
modification of definitions relating to engineering controls; revision 
and updating of the Exposure Control Plan; solicitation of employee 
input; and recordkeeping.
    The revised standard adds two additional terms to the definition 
section found in paragraph (b) and alters the definition of one other 
term. It adds ``Sharps with Engineered Sharps Injury Protections'' and 
defines this term as ``a nonneedle sharp or a needle device used for 
withdrawing body fluids, accessing a vein or artery, or administering 
medications or other fluids, with a built-in safety feature or 
mechanism that effectively reduces the risk of an exposure incident.'' 
This term encompasses a broad array of devices that make injury 
involving a contaminated sharp less likely, and includes, but is not 
limited to, syringes with a sliding sheath that shields the attached 
needle after use; needles that retract into a syringe after use; 
shielded or retracting catheters used to access the bloodstream for 
intravenous administration of medication or fluids; and intravenous 
medication delivery systems that administer medication or fluids 
through a catheter port or connector site using a needle that is housed 
in a protective covering.
    The revised standard also adds the term ``Needleless Systems,'' 
which is defined as ``a device that does not use needles for: (A) The 
collection of bodily fluids or withdrawal of body fluids after initial 
venous or arterial access is established; (B) the administration of 
medication or fluids; or (C) any other procedure involving the 
potential for occupational exposure to bloodborne pathogens due to 
percutaneous injuries from contaminated sharps.'' ``Needleless 
Systems'' provide an alternative to needles for the specified 
procedures, thereby reducing the risk of percutaneous injury involving 
contaminated sharps. Examples of needleless systems include, but are 
not limited to, intravenous medication delivery systems that administer 
medication or fluids through a catheter port or connector site using a 
blunt cannula or other non-needle connection, and jet injection systems 
that deliver subcutaneous or intramuscular injections of liquid 
medication through the skin without use of a needle.
    The definition of ``Engineering Controls'' has been modified to 
include as examples ``safer medical devices, such as sharps with 
engineered sharps injury protections and needleless systems.'' This 
change clarifies that safer medical devices are considered to be 
engineering controls under the standard. The term ``Engineering 
Controls'' includes all control measures that isolate or remove a 
hazard from the workplace, encompassing not only sharps with engineered 
sharps injury protections and needleless systems but also other medical 
devices designed to reduce the risk of percutaneous exposure to 
bloodborne pathogens. Examples include blunt suture needles and plastic 
or mylar-wrapped glass capillary tubes, as well as controls that are 
not medical devices, such as sharps disposal containers and biosafety 
cabinets.
    The expanded definitions reflect the intent of Congress to have 
OSHA amend the BBP standard to clarify

* * * the direction already provided by OSHA in its Compliance 
Directive; namely, that employers who have employees with 
occupational exposure to bloodborne pathogens must consider and, 
where appropriate, use effective engineering controls, including 
safer medical devices, in order to reduce the risk of injury from 
needlesticks and from other sharp medical instruments * * * (Ex. 5-
3).

Thus, the revised definitions do not reflect any new requirements being 
placed on employers with regard to protecting workers from sharps 
injuries, but are meant only to clarify the original standard, and to 
reflect the development of new safer medical devices since that time.
    Paragraph (c)(1)(iv) of the standard is revised to add new 
requirements to the annual review and update of the Exposure Control 
Plan. The review and update of the plan is now required to ``(A) 
reflect changes in technology that eliminate or reduce exposure to 
bloodborne pathogens; and (B) document annually consideration and 
implementation of appropriate commercially available and effective 
safer medical devices designed to eliminate or minimize occupational 
exposure.'' Thus, the additional provisions require that employers, in 
their written Exposure Control Plans, account for innovations in 
procedure and technological developments that reduce the risk of 
exposure incidents. This would include, but would not be limited to, 
newly available medical devices designed to reduce the risk of 
percutaneous exposure to bloodborne pathogens. Consideration and 
implementation of safer medical devices could be documented in the 
Exposure Control Plan by describing the safer devices identified as 
candidates for adoption; the method or methods used to evaluate devices 
and the results of evaluations; and justification for selection 
decisions. This information must be updated at least annually.
    The revised Exposure Control Plan requirements make clear that 
employers must implement the safer medical devices that are 
appropriate, commercially available, and effective. No one medical 
device is appropriate in all circumstances of use. For purposes of this 
standard, an ``appropriate'' safer medical device includes only devices 
whose use, based on reasonable judgment in individual cases, will not 
jeopardize patient or employee safety or be medically contraindicated. 
Although new devices are being continually introduced, OSHA recognizes 
that a safer device may not be available for every situation. If a 
safer device is not available in the marketplace, the employer is not 
required to develop any such device. Furthermore, the revised 
requirements are limited to the safer medical devices that are 
considered to be ``effective.'' For purposes of this standard, an 
``effective'' safer medical device is a device that, based on 
reasonable judgment, will make an exposure incident involving a 
contaminated sharp less likely to occur in the application in which it 
is used.
    Paragraph (c)(1)(v) of the revised standard now requires that ``An 
employer, who is required to establish an Exposure Control Plan shall 
solicit input from non-managerial employees responsible for direct 
patient care who are potentially exposed to injuries from contaminated 
sharps in the identification, evaluation, and selection of effective 
engineering and work practice controls and shall document the 
solicitation in the Exposure Control Plan.'' This change represents a 
new requirement, which is performance-oriented. No specific procedures 
for obtaining employee input are prescribed. This provides the employer 
with flexibility to solicit employee input in any manner appropriate to 
the circumstances of the workplace. A dental office employing two 
hygienists, for example, may choose to conduct periodic conversations 
to discuss identification, evaluation, and selection of controls. A 
large hospital, on the other hand, would likely find that an effective 
process for soliciting employee input requires the implementation of 
more formal procedures. The solicitation of input required by the 
standard requires employers to take reasonable steps to obtain employee 
input in the identification, evaluation, and selection of controls. 
Methods for soliciting employee input may include

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involvement in informal problem-solving groups; participation in safety 
audits, worksite inspections, or exposure incident investigations; 
participation in analysis of exposure incident data or in job or 
process hazard analysis; participation in the evaluation of devices 
through pilot testing; and involvement in a safety and health committee 
properly constituted and operated in conformance with the National 
Labor Relations Act.
    Employee input can serve to assist the employer in overcoming 
obstacles to the successful implementation of control measures. A 
number of respondents to the RFI indicated that they encountered some 
resistance when new devices required staff members to adopt new 
techniques, or when staff members perceived that use of the device 
might have an adverse effect on the patient (e.g., Exs. 3-50, 3-79, 3-
99, 3-133). As a way of addressing this resistance, staff involvement 
in the selection process can play an important role in the acceptance 
and proper use of safer medical devices (e.g., Exs. 3-18, 3-42, 3-56, 
3-88, 3-324, 3-355). According to their experience, the participation 
of frontline workers can help to overcome the following barriers:
    <bullet> Safer medical devices often require adjustments in 
technique, and a number of respondents noted that staff members are 
often reluctant to revise practices to which they have become 
accustomed.
    <bullet> Equipment compatibility problems. With the broad array of 
devices being used in healthcare settings, it is critical to ensure 
that devices will work together when necessary.
    <bullet> The need for continued evaluation of devices and the 
allotment of sufficient time for adequate device evaluation. After 
initial use by employees, some facilities found it necessary to replace 
the device originally selected with a more suitable device.
    The Community Health Network (CHN) of San Francisco provides an 
example of a safety and health committee with responsibility for sharps 
injury prevention (Ex. 5-5). Representatives of both labor and 
management serve on the committee, and are provided with access to non-
confidential information regarding bloodborne pathogen exposure 
incidents at CHN facilities. The committee is responsible for 
establishing criteria for safer devices; overseeing device evaluation 
by representative groups of device users; and selecting preferred 
devices for purchase. The committee is also responsible for developing 
safer alternatives to work practices that are associated with exposure 
incidents.
    The concept of involving a team in sharps injury prevention 
programs is supported by the American Hospital Association (AHA) in 
guidelines to assist hospitals and health systems in developing such 
programs (Ex. 5-1). According to AHA, a successful program revolves 
around communication, education, training, and collaboration. Among the 
specific steps recommended are assembling a multidisciplinary team that 
includes representation of frontline workers and departments using 
devices; selecting targeted devices for evaluation; pilot-testing of 
devices; and collecting data after a device is adopted to evaluate its 
impact.
    The standard requires that employers seek input from non-managerial 
employees responsible for direct patient care who are potentially 
exposed to injuries from contaminated sharps. Employees involved in 
administering treatment or performing any procedure in the presence of 
an individual receiving care are considered to be involved in direct 
patient care. For example, an employee who uses a needled syringe to 
collect blood from patients in a nursing home, or an employee who 
administers flu vaccinations in a factory employee health unit, would 
both be considered to be involved in direct patient care and engaged in 
activities that put them at risk of direct exposure due to needlestick 
injuries. Employers may also choose to include other employees in the 
request for input, such as lab technicians, housekeeping staff, 
maintenance workers, and management-level personnel who may be at risk 
of injury involving contaminated sharps. An employer who is otherwise 
required to establish an Exposure Control Plan under the standard, but 
does not have any non-managerial employees responsible for direct 
patient care who are potentially exposed to injuries from contaminated 
sharps, is not required to solicit employee input with respect to this 
provision.
    The revised standard does not require employers to request input 
from all potentially exposed employees involved in direct patient care; 
however, the employees involved by the employer should represent the 
range of exposure situations encountered in the workplace. Input from 
employees covered by a collective-bargaining agreement may also be 
requested through their authorized bargaining agent.
    The revised standard requires that solicitation of input from 
employees be documented in the Exposure Control Plan. Employers can 
meet this obligation by identifying the employees who were involved and 
describing the process by which input was requested. Employers should 
also describe the input obtained with regard to identification, 
evaluation, and selection of controls. Evidence that employee input has 
been sought can include, for example, meeting minutes, copies of 
documents used to request employee participation, or records of 
responses received from employees such as reports evaluating the 
effectiveness of a safer medical device in trial applications.
    The requirement for solicitation of input from employees has been 
designated as paragraph (c)(1)(v) in the revised standard. The 
requirement that the Exposure Control Plan be made available to the 
Assistant Secretary of Labor for Occupational Safety and Health and the 
Director of the National Institute for Occupational Safety and Health 
upon request, previously designated as paragraph (c)(1)(v), has been 
moved and is now paragraph (c)(1)(vi) in the revised standard.
    The recordkeeping requirements of the standard at paragraph (h) 
have been amended by adding paragraph (h)(5) to require that employers 
maintain a sharps injury log to serve as a tool for identifying high 
risk areas and evaluating devices. Paragraph (h)(5)(i) now states, 
``The employer shall establish and maintain a sharps injury log for the 
recording of percutaneous injuries from contaminated sharps. The 
information in the sharps injury log shall be recorded and maintained 
in such manner as to protect the confidentiality of the injured 
employee. The sharps injury log shall contain, at a minimum: (A) The 
type and brand of device involved in the incident, (B) the department 
or work area where the exposure incident occurred, and (C) an 
explanation of how the incident occurred.'' The sharps injury log must 
be maintained for the period required by 29 CFR 1904. The requirement 
to establish and maintain the log only applies to employers who are 
otherwise required to maintain a log of occupational injuries and 
illnesses under 29 CFR 1904 (OSHA's Recordkeeping rule).
    The sharps injury log must include the specified minimum 
information regarding the device involved (if known), the location of 
the incident, and the description of the events that resulted in the 
injury. The level of detail presented should be sufficient to allow 
ready identification of the device, location, and circumstances 
surrounding an exposure incident (e.g.,

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the procedure being performed, the body part affected, objects or 
substances involved and how they were involved) so that the intended 
evaluation of risk and device effectiveness can be accomplished.
    Information in the sharps injury log must be recorded and 
maintained in a manner that protects the privacy of the injured 
employee. If data from the log are made available to other parties, any 
information that directly identifies an employee (e.g., name, address, 
social security number, payroll number) or information that could 
reasonably be used to identify indirectly a specific employee (e.g., 
exact age, date of initial employment) must be withheld.
    The format of the sharps injury log is not specified. The employer 
is permitted to determine the format in which the log is maintained 
(e.g., paper or electronic), and may include information in addition to 
that required by the standard, so long as the privacy of injured 
workers is protected. The Agency recognizes that many employers already 
compile reports of percutaneous exposure incidents in a variety of 
ways. Existing mechanisms for collecting these reports will be 
considered sufficient to meet the requirements of the standard for 
maintaining a sharps injury log, provided that the information gathered 
meets the minimum requirements specified in the standard, and the 
confidentiality of the injured employee is protected.
    Under newly published revisions to OSHA's Recordkeeping rule (29 
CFR 1904), employers are required to record sharps injuries involving 
contaminated objects on the OSHA 300 Log of Work-Related Injuries and 
Illnesses and the OSHA 301 Injury and Illness Incident Report (the new 
forms replace the current 200 and 101 forms). When the revisions become 
effective, employers may elect to use the OSHA 300 and 301 forms to 
meet the sharps injury log requirements, provided two conditions are 
met. First, the employer must enter the type and brand of the device on 
either the 300 or 301 form. Second, the employer must maintain the 
records in a way that segregates sharps injuries from other types of 
work-related injuries and illnesses, or allows sharps injuries to be 
easily separated. For example, if OSHA 300 and 301 records are 
maintained on a computer, the employer must ensure that the computer is 
able to produce a record of sharps injuries that does not include other 
types of work-related injuries and illnesses (i.e., through using a 
program that allows for sorting of entries by injury type). If records 
are kept on paper forms, the employer would need to use a separate page 
of the 300 Log for sharps injuries.
    The revisions to the Recordkeeping rule will not become effective 
until January 1, 2002, at the earliest, and until then many sharps 
injuries involving contaminated objects will not be recordable on the 
OSHA log. Therefore, employers must keep a separate sharps log from the 
effective date of this rule until the revised Recordkeeping rule 
becomes effective.
    These revisions to the BBP standard become effective April 18, 
2001. Exposure Control Plans that are reviewed and updated on or after 
this effective date must reflect the requirements of the revised 
standard. Percutaneous exposure incidents that occur on or after this 
effective date must be recorded on the sharps injury log.
    OSHA's BBP standard, including the amendments herein promulgated, 
is applicable to general industry and shipyard employment (as 
referenced in 29 CFR 1915.1030).

IV. Economic Analysis

Incremental Costs of the Mandated Revisions to the Standard

    OSHA has determined that the total cost of this action is 
$33,814,991 per year, and thus, that it is not an economically 
significant regulatory action within the meaning of Executive Order 
12866. However, the rule is defined as a significant rule under the 
Executive Order, and has been reviewed by the Office of Management and 
Budget. This amendment to the final standard does not involve any new 
engineering requirements to protect workers from sharps injuries, but 
it does include two new recordkeeping requirements: First, the amended 
standard requires employers to ``establish and maintain a sharps injury 
log for the recording of percutaneous injuries * * *'' However, for 
recordable needlestick incidents, OSHA already requires employers to 
collect much of the information needed for developing such a log under 
other rules, the Recording and Reporting Occupational Injuries and 
Illnesses regulation (29 CFR 1904) in particular. Moreover, OSHA has 
recently published revisions to 29 CFR 1904 that would cover the 
remaining, previously nonrecordable needlestick injuries. Second, the 
current action requires any employer ``who is required to establish an 
Exposure Control Plan'' to ``solicit input from non-managerial 
employees responsible for direct patient care who are potentially 
exposed to injuries from contaminated sharps in the identification, 
evaluation, and selection of effective engineering and work practice 
controls and shall document the solicitation in the Exposure Control 
Plan.'' The methodology OSHA has used for computing costs for each 
requirement of the amended standard is presented in the next two 
sections.

Cost of Establishing and Maintaining a Sharps Injury Log

    The rule requires employers to maintain a log for all needlestick 
and sharps injuries. At a minimum, the sharps injury log must contain: 
``(A) The type and brand of device involved in the incident, (B) the 
department or work area where the exposure incident occurred, and (C) 
an explanation of how the incident occurred.'' The costs attributable 
to the log correspond directly to the number of needlestick and sharps 
injuries. The International Health Care Worker Safety Center (IHCWSC) 
provides the best available estimate of the number of needlestick 
injuries (Ex. 3-172V). IHCWSC has computed that 590,164 needlestick and 
sharps injuries occur annually.
    Needlestick and sharps injury cases will require an effort 
pertaining to collection of data on the type and brand of device, the 
department or work area where the incident occurred, and an explanation 
of how the incident occurred. Because the amount of information 
required to be collected is limited, OSHA estimates that it will 
require an average of five minutes per case (0.08 hours) to collect the 
data and enter it onto the separate log. Assuming that the task of 
collecting information related to the incident and entry onto the log 
will be conducted by an individual with the skill level of a Personnel 
Training and Labor Relations Specialist, an hourly wage of $26.32 is 
used to compute cost. (The hourly wage for Personnel Training and Labor 
Relations Specialist as reported in the Bureau of Labor Statistics 
Occupational Employment Statistics Survey is $19.03; benefits are 
computed at 38.3 percent of the hourly wage.) Thus, the incremental 
annual cost of the separate sharps injury log is:

(590,164 cases)  x  (0.08 hours/case)  x  ($26.32/hour) = $1,294,352.


[[Page 5322]]


    In summary, OSHA estimates that the total annual cost of 
maintaining a sharps injury log will be $1,294,352. This estimate is 
likely to overstate true costs for at least three reasons. First, for 
already recordable incidents, the data needed to maintain a separate 
sharps injury log are already collected and entered into a log format 
for other purposes, namely for the requirements set forth by 29 CFR 
Part 1904. It is unlikely that the data will need to be ``re-entered.'' 
Instead, businesses are likely to develop procedures for automating the 
process or for organizing log information, thereby significantly 
reducing the incremental costs associated with this incremental action. 
For nonrecordable cases, the data collection required by the 
Needlestick Safety and Prevention Act and this revision to the BBP 
standard will be required under 29 CFR Part 1904 (once revisions to 
Part 1904 become effective), so that the incremental costs associated 
with the separate sharps injury log are short-term in nature. Finally, 
and perhaps most importantly, the above cost estimate significantly 
overstates costs because it includes costs for all establishments in 
SIC 80. Under revisions to 29 CFR Part 1904, SICs 801, 802, 803, 804, 
807, and 809 are exempted from recordkeeping requirements under Part 
1904 and will thus not be required by this amendment to the BBP 
standard to keep a needlestick and sharps injury log. This is 
potentially significant because SICs 801, 802, 803, 804, 807, and 809 
constitute 31 percent of employment for SIC 80, though not necessarily 
31 percent of sharps injuries.

Cost of Solicitation of Employee Input

    The cost associated with solicitation of employee input is 
comprised of three components: (1) The initial solicitation, conducted 
by a manager; (2) the employee response; and (3) documentation of the 
solicitation in the Exposure Control Plan.
    The cost of the initial solicitation is likely to vary with 
establishment size, number of incidents, and employee interest. The 
establishments that will be affected are those that are: (1) Required 
to develop an Exposure Control Plan, and (2) have employees who are 
involved in direct patient care and who are potentially exposed to 
needlestick injuries. The overwhelming majority of such establishments 
are in SIC 80, Health Services. County Business Patterns reports that 
in 1997 (1997 data are used as the most recent year for which data are 
available using the SIC reporting system), there were 502,724 
establishments in SIC 80. OSHA estimates that the initial solicitation 
or call for employee input will require an average of 15 minutes (0.25 
hours) of managerial time. The wage rate of a Medicine and Health Care 
Manager is $33.22 per hour, including fringe benefits. (The hourly wage 
for a Medicine and Health Care Manager reported in the Bureau of Labor 
Statistics Occupational Employment Statistics Survey is $24.02; 
benefits are computed at 38.3 percent of the hourly wage.) The 
estimated cost of the initial solicitation is:

(502,724 establishments)  x  (0.25 hours/establishment)  x  ($33.22/
hour) = $4,175,080.

    The cost associated with the employee response varies with the 
number of employees and the response rate to the initial solicitation. 
According to County Business Patterns, there were 11,348,141 
individuals employed in SIC 80 in 1997. OSHA estimates that it will 
require 15 minutes (0.25 hours) of employee time to respond to the 
solicitation and that approximately 33 percent of employees will 
respond. Using a wage rate of $25.90 (which is the total hourly 
compensation in 1998 for professional specialty and technical employees 
in Health Services reported in the Bureau of Labor Statistics 
publication Employer Costs for Employee Compensation, 1986-1988), the 
estimated costs associated with employee response are:

(11,348,141 employees)  x  (33% response rate)  x  (0.25 hours/
employee)  x  ($25.90/hour) = $24,248,140.

Note that it is implicitly assumed that input is solicited from all 
employees. This assumption will result in an overstatement of costs 
because the standard requires that input be solicited only from the 
fraction of employees who are involved in direct patient care and who 
are potentially exposed to needlestick injuries.
    Finally, the revised standard requires that the employer document 
the solicitation in the Exposure Control Plan. Because the affected 
employers are already required to establish a Plan, the incremental 
effort associated with this documentation will be small. OSHA estimates 
that it will require only 15 minutes (0.25 hours) of managerial time. 
Thus, the total annual cost of documenting the solicitation in the 
Exposure Control Plan is estimated to be:
(502,724 establishments)  x  (0.25 hours/establishment)  x  ($33.22/
hour) = $4,175,080.
    In summary, OSHA has estimated the total cost of the solicitation 
to be $32,598,300 ($4,175,080 + $24,248,140 + $4,175,080). This 
estimate is likely to overstate the cost because employers have several 
avenues for achieving this requirement of the standard, many of which 
will reduce costs. For example, employers are not required to solicit 
input from all employees and could meet the requirement by, for 
example, consulting a properly constituted safety committee consisting 
of a subset of employees. In fact, recent state legislation has 
mandated sharps safety committees in a number of states. In these 
situations, the only incremental cost associated with the solicitation 
mandated by this amendment to the BBP standard will be documentation of 
the solicitation in the Exposure Control Plan.

Total Cost and Cost Per Establishment

    According to the above analysis, the maximum total annual cost of 
this action is $33,892,653, consisting of $1,294,352 associated with 
maintaining a sharps injury log and $32,598,300 associated with 
soliciting and documenting employee input into the Exposure Control 
Plan. This amounts to $67 per establishment, per year, which will not 
cause significant economic impact on either large or small affected 
establishments.

V. Unfunded Mandates

    OSHA has determined that, for the purposes of section 202 of the 
Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532), this rule does 
not include any

[[Page 5323]]

federal mandate that may result in increased expenditures by state, 
local, or tribal governments in the aggregate of more than $100 
million, or increased expenditures by the private sector of more than 
$100 million. Moreover, the Agency has determined that for purposes of 
section 203 of the Act, this rule does not significantly or uniquely 
affect these entities.

Background

    The Unfunded Mandates Reform Act was enacted in 1995. While much of 
the Act is designed to assist the Congress in determining whether its 
actions will impose costly new mandates on state, local, and tribal 
governments, the Act also includes requirements to assist federal 
agencies to make this same determination with respect to regulatory 
actions.

Analysis

    As discussed in Section IV, Economic Analysis, this rule will have 
incremental costs of $34 million per year, all of which are associated 
with maintaining the sharps injury log and soliciting and documenting 
employee information. These total costs represent an average cost of 
$67 per year per affected establishment. OSHA does not anticipate any 
disproportionate budgetary effects upon any particular region of the 
nation, or particular state, local or tribal governments, or urban or 
rural communities.

VI. Environmental Impacts

    The National Environmental Policy Act requires that ``major Federal 
actions significantly affecting the quality of the human environment'' 
be accompanied by a statement addressing the environmental impact of 
the proposed action. (42 U.S.C. 4332(C)) Department of Labor 
regulations establish a criteria for determining when an environmental 
impact statement is required in a rulemaking proceeding:

    Preparation of an environmental impact statement will always be 
required for proposals for promulgation, modification or revocation 
of health standards which will significantly affect air, water or 
soil quality, plant or animal life, the use of land or other aspects 
of the human environment.

29 CFR 11.10 (a)(3)

    OSHA has concluded that no significant environmental impacts would 
result from this rulemaking. This final standard expands the universe 
of engineering controls permissible for reducing occupational exposure 
to bloodborne pathogens. It also widens the scope of Exposure Control 
Plan review, requires maintenance of a sharps injury log, and mandates 
the solicitation of input from employees on the identification, 
evaluation, and selection of effective engineering and work practice 
controls. The Agency has not identified any impacts of these 
requirements on the environment.

VII. Federalism

    This standard has been reviewed in accordance with the Executive 
Order on Federalism (Executive Order 13132, 64 FR 43255, Aug. 10, 
1999). The order requires that agencies, to the extent possible, 
refrain from limiting state policy options; consult with states prior 
to taking actions that would restrict state policy options; and take 
such action only when there is clear constitutional authority and the 
presence of a problem of national scope. Executive Order 13132 also 
provides that agencies shall not promulgate regulations that have 
significant Federalism implications and impose substantial direct 
compliance costs on state or local governments, unless the agency 
consults with state and local officials early in the process of 
developing the proposed regulation and provides a summary Federalism 
impact statement in the preamble of the final rule. Finally, the Order 
provides for preemption of state law only if there is a clear 
Congressional intent for the agency to do so, and provides that any 
such preemption is to be limited to the extent possible.
    Under Section 6(b) of the Executive Order, an agency is exempt from 
state consultation requirements if it is promulgating a regulation that 
is required by statute. The amendments to OSHA's BBP standard codified 
in this rule were explicitly written by Congress and enacted as Public 
Law 106-430. Moreover, Congress clearly intended the revised BBP 
standard to have the same legal effect as other standards issued under 
6(b) of the Occupational Safety and Health Act of 1970. Nonetheless, 
OSHA has consulted extensively with those 25 States and territories 
that operate OSHA-approved State plans with regard to OSHA policy on 
safe needle devices and the requirements of the subject legislation.
    Section 18 of the OSH Act expresses Congress' intent to preempt 
state laws relating to issues on which Federal OSHA has promulgated 
occupational safety and health standards. Under the OSH Act, a state 
can avoid preemption only if it submits, and receives Federal approval 
for, a State plan for the development and enforcement of standards. 
OSHA-approved State plans operate under authority of State law and must 
adopt occupational safety and health standards which, among other 
things, must be at least as effective in providing safe and healthful 
employment and places of employment as Federal standards.
    In Gade v. National Solid Wastes Management Assoc., the U.S. 
Supreme Court reaffirmed the view that Section 18 of the OSH Act 
effectively preempts states without approved plans from adopting or 
enforcing any laws that directly, substantially, and specifically 
regulate occupational safety and health. 505 U.S. 88, 107 (1992). 
However, needlestick laws in states without an OSHA-approved State plan 
would not be affected to the extent to which they regulate the 
occupational safety and health conditions of state or local government 
employees (see Section 3(5) of the OSH Act).

VIII. State Plan States

    The 23 states and 2 territories that operate their own federally 
approved occupational safety and health plans must adopt a comparable 
amended standard within six months of the publication date of a final 
Federal OSHA standard. The States and territories with this obligation 
include: Alaska, Arizona, California, Connecticut (for State and local 
government employees only), Hawaii, Indiana, Iowa, Kentucky, Maryland, 
Michigan, Minnesota, Nevada, New Mexico, New York (for State and local 
government employees only), North Carolina, Oregon, Puerto Rico, South 
Carolina, Tennessee, Utah, Vermont, Virginia, Virgin Islands, 
Washington, and Wyoming. Until such time as state and territorial 
standards are amended, Federal OSHA will provide interim enforcement 
assistance, as appropriate.

IX. Paperwork Reduction Act

    This final rule contains new collection of information (paperwork) 
requirements in revisions to the Bloodborne Pathogen Standard 
(1910.1030 and 1915.1030) made as a result of the Needlestick Safety 
and Prevention Act (Pub. L. 106-430). These new paperwork requirements 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA 95), 44 U.S.C. 3501 et 
seq., and its regulation at 5 CFR Part 1320. OSHA solicits public 
comments concerning its estimate of the burden hours and costs for the 
revised paperwork requirements. The Agency will summarize the comments 
received and include a summary of them in its request to OMB to approve 
the information collection requirements; they will also become a matter 
of public record. OSHA seeks this information as part of its continuing 
effort to reduce

[[Page 5324]]

paperwork and respondent burden. The information helps to ensure that 
requested data can be provided in the desired format, reporting burden 
(time and financial resources) is minimized, collection instruments are 
clearly understood, and the impact of collection requirements on 
respondents can be properly assessed.
    The Needlestick Safety and Prevention Act requires employers, who 
have exposure control plans in accordance with Sec. 1910.1030 
(c)(1)(iv), ``to review and update such plans to reflect changes in 
technology that eliminate or reduce exposure to bloodborne pathogens.'' 
The exposure control plan must also ``document consideration and 
implementation of appropriate commercially available and effective 
safer medical devices designed to eliminate or minimize occupational 
exposure.'' Employers required to have exposure control plans must also 
``solicit input from non-managerial employees responsible for direct 
patient care who are potentially exposed to injuries from contaminated 
sharps in the identification, evaluation, and selection of effective 
engineering and work practice controls and shall document the 
solicitation in the Exposure Control Plan.''
    The Needlestick Safety and Prevention Act also requires employers, 
who currently maintain a log of occupational injuries and illnesses 
under 29 CFR 1904, to ``establish and maintain a sharps injury log for 
the recording of percutaneous injuries from contaminated sharps.'' The 
information in the sharps injury log must be recorded and maintained so 
that the confidentiality of the injured worker is protected. The log 
must contain at least the following information: ``(A) the type and 
brand of device involved in the incident; (B) the department or work 
area where the exposure incident occurred; and (C) an explanation of 
how the incident occurred.''
    Respondents are not required to comply with collection of 
information (paperwork) requirements unless a currently valid OMB 
control number is displayed (Sec. 1320.5 (b)(2)(i)). OSHA will publish 
the OMB control number as soon as it receives approval on its ICR for 
the revised collections. A copy of the Agency's revised ICR for the BBP 
standard is available for inspection and copying as part of Docket 
ICR1218-0180(2000) in the OSHA Docket Office, U.S. Department of Labor, 
Room N-2625, 200 Constitution Avenue, NW., Washington, DC 20210, or you 
may request a mailed copy by telephoning Todd Owen at (202) 693-2444.
    Comments on the ICR should be submitted to the Docket Office, 
Docket Number ICR-0180 (2001), OSHA, U.S. Department of Labor, Room N-
2625, 200 Constitution Avenue, NW., Washington, DC 20210, telephone: 
(202) 693-2350. Commenters may transmit written comments of 10 pages or 
less in length by facsimile to (202) 693-1648.
    The Department and OMB are particularly interested in comments that
    <bullet> Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    <bullet> Evaluate the accuracy of the Agency's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used;
    <bullet> Enhance the quality, utility, and clarity of the 
information to be collected; and
    <bullet> Minimize the burden of the collection of information on 
those who are to respond, including through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses.
    Title: Bloodborne Pathogens standard (29 CFR 1910.1030).
    OMB Number: 1218-0180 (Revision).
    Frequency: Employers must: annually review their exposure control 
plans; initially establish and maintain a sharps injury log; as 
necessary, make injury recordings in the log; and solicit input from 
non-managerial employees.
    Affected Public: The respondents are those employers that must 
maintain an exposure control plan, and employers who are required to 
maintain a log of occupational injuries and illnesses under 29 CFR part 
1904.
    Total Respondents: 502,724 establishments.
    Average time per response: Three to five minutes for employers to 
record needlestick incidents; fifteen minutes for employers to solicit 
non-managerial employees on effective engineering and work practice 
controls; fifteen minutes for employers to modify their existing 
exposure control plans.
    Estimated Burden Hours: 49,180 hours for employers to log 
needlestick incidents; 125,681 hours for employers to solicit non-
managerial employees; and 125,681 hours for employers to update 
existing exposure control plans.
    Estimated Cost (Operation and Maintenance): 0.

X. Authority and Signature

    This document was prepared under the direction of Charles N. 
Jeffress, Assistant Secretary of Labor for Occupational Safety and 
Health, U.S. Department of Labor, 200 Constitution Avenue, NW., 
Washington, DC 20210.
    Accordingly, pursuant to sections 4, 6, and 8 of the Occupational 
Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657) and the 
Needlestick Safety and Prevention Act (Pub. L. 106-430, 114 Stat. 1901, 
November 6, 2000); and Secretary of Labor's Order No. 3-2000 (65 FR 
50017), 29 CFR part 1910 is amended as set forth below.

List of Subjects in 29 CFR Part 1910

    Blood, Blood diseases, Health, Healthcare, Hepatitis B virus, 
Hepatitis C virus, Hospitals, Human immunodeficiency virus, 
Needlestick, Occupational safety and health, Sharps injury.

    Signed at Washington, DC, this 10th day of January 2001.
Charles N. Jeffress,
Assistant Secretary of Labor for Occupational Safety and Health.

XI. Amended Final Rule and Appendix

    The Occupational Safety and Health Administration is amending part 
1910 of title 29 of the Code of Federal Regulations as follows:

PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS

    1. The authority citation for 29 CFR part 1910, subpart Z, is 
revised to read as follows:

    Authority: Sections 4, 6, and 8 of the Occupational Safety and 
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's 
Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 
35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), or 3-2000 (65 FR 
50017), as applicable; and 29 CFR part 1911.
    All of subpart Z issued under Sec. 6(b) of the Occupational 
Safety and Health Act, except those substances that have exposure 
limits listed in Tables Z-1, Z-2, and Z-3 of 29 CFR 1910.1000. The 
latter were issued under Sec. 6(a) (29 U.S.C. 655(a)).
    Section 1910.1000, Tables Z-1, Z-2 and Z-3 also issued under 5 
U.S.C. 553, Section 1910.1000 Tables Z-1, Z-2, and Z-3 not issued 
under 29 CFR part 1911 except for the arsenic (organic compounds), 
benzene, and cotton dust listings.
    Section 1910.1001 also issued under section 107 of the Contract 
Work Hours and Safety Standards Act (40 U.S.C. 333) and 5 U.S.C. 
553.
    Section 1910.1002 not issued under 29 U.S.C. 655 or 29 CFR part 
1911; also issued under 5 U.S.C. 553.
    Sections 1910.1018, 1910.1029 and 1910.1200 are also issued 
under 29 U.S.C. 653.

[[Page 5325]]

    Section 1910.1030 is also issued under Pub. L. 106-430, 114 
Stat. 1901.
* * * * *

    2. Section 1910.1030 is amended as follows:
    A. In Sec. 1910.1030, paragraph (b), the definition for 
``Engineering Controls'' is revised and definitions are added in 
alphabetical order to read as set forth below:
    B. Paragraph (c)(1)(iv) is revised to read as set forth below:
    C. Paragraph (c)(1)(v) is redesignated paragraph (c)(1)(vi), and a 
new paragraph (c)(1)(v) is added to read as set forth below:
    D. A new paragraph (h)(5) is added to read as set forth below:


Sec. 1910.1030  Bloodborne pathogens.

* * * * *
    (b) * * *
    Engineering controls means controls (e.g., sharps disposal 
containers, self-sheathing needles, safer medical devices, such as 
sharps with engineered sharps injury protections and needleless 
systems) that isolate or remove the bloodborne pathogens hazard from 
the workplace.
* * * * *
    Needleless systems means a device that does not use needles for:
    (1) The collection of bodily fluids or withdrawal of body fluids 
after initial venous or arterial access is established;
    (2) The administration of medication or fluids; or
    (3) Any other procedure involving the potential for occupational 
exposure to bloodborne pathogens due to percutaneous injuries from 
contaminated sharps.
* * * * *
    Sharps with engineered sharps injury protections means a nonneedle 
sharp or a needle device used for withdrawing body fluids, accessing a 
vein or artery, or administering medications or other fluids, with a 
built-in safety feature or mechanism that effectively reduces the risk 
of an exposure incident.
* * * * *
    (c) * * *
    (1) * * *
    (iv) The Exposure Control Plan shall be reviewed and updated at 
least annually and whenever necessary to reflect new or modified tasks 
and procedures which affect occupational exposure and to reflect new or 
revised employee positions with occupational exposure. The review and 
update of such plans shall also:
    (A) Reflect changes in technology that eliminate or reduce exposure 
to bloodborne pathogens; and
    (B) Document annually consideration and implementation of 
appropriate commercially available and effective safer medical devices 
designed to eliminate or minimize occupational exposure.
    (v) An employer, who is required to establish an Exposure Control 
Plan shall solicit input from non-managerial employees responsible for 
direct patient care who are potentially exposed to injuries from 
contaminated sharps in the identification, evaluation, and selection of 
effective engineering and work practice controls and shall document the 
solicitation in the Exposure Control Plan.
* * * * *
    (h) * * *
    (5) Sharps injury log. (i) The employer shall establish and 
maintain a sharps injury log for the recording of percutaneous injuries 
from contaminated sharps. The information in the sharps injury log 
shall be recorded and maintained in such manner as to protect the 
confidentiality of the injured employee. The sharps injury log shall 
contain, at a minimum:
    (A) The type and brand of device involved in the incident,
    (B) The department or work area where the exposure incident 
occurred, and
    (C) An explanation of how the incident occurred.
    (ii) The requirement to establish and maintain a sharps injury log 
shall apply to any employer who is required to maintain a log of 
occupational injuries and illnesses under 29 CFR 1904.
    (iii) The sharps injury log shall be maintained for the period 
required by 29 CFR 1904.6.
* * * * *
[FR Doc. 01-1207 Filed 1-17-01; 8:45 am]
BILLING CODE 4510-26-P