5318 Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations

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

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 postexposure 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.).

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

5320 Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations

involvement in informal problemsolving 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 nonconfidential 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; pilottesting 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 managementlevel 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.,

Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations 5321

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 WorkRelated 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) × (0.08 hours/case) × ($26.32/hour) = $1,294,352.

5322 Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations

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) × (0.25 hours/establishment) × ($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) × (33% response rate) × (0.25 hours/employee) × ($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) × (0.25 hours/establishment) × ($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

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

5324 Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations

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 § 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 (§ 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.

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

§ 1910.1030 Bloodborne pathogens.

* * * * *

(b) * * *

Engineering controls means controls

(e.g., sharps disposal containers, selfsheathing 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]

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