[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:
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.
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.
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
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;
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;
Enhance the quality, utility, and clarity of the
information to be collected; and
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