PUBLIC LAW 106–430—NOV. 6, 2000 114 STAT. 1901

Public Law 106–430

106th Congress

An Act

To require changes in the bloodborne pathogens standard in effect under the Occupational Safety and Health Act of 1970.

Be it enacted by the Senate and House of Representatives of

the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘Needlestick Safety and Prevention

Act’’.

SEC. 2. FINDINGS.

The Congress finds the following:

(1) Numerous workers who are occupationally exposed to

bloodborne pathogens have contracted fatal and other serious

viruses and diseases, including the human immunodeficiency

virus (HIV), hepatitis B, and hepatitis C from exposure to

blood and other potentially infectious materials in their workplace.

(2) In 1991 the Occupational Safety and Health Administration issued a standard regulating occupational exposure to

bloodborne pathogens, including the human immunodeficiency

virus, (HIV), the hepatitis B virus (HBV), and the hepatitis

C virus (HCV).

(3) Compliance with the bloodborne pathogens standard

has significantly reduced the risk that workers will contract

a bloodborne disease in the course of their work.

(4) Nevertheless, occupational exposure to bloodborne

pathogens from accidental sharps injuries in health care settings continues to be a serious problem. In March 2000, the

Centers for Disease Control and Prevention estimated that

more than 380,000 percutaneous injuries from contaminated

sharps occur annually among health care workers in United

States hospital settings. Estimates for all health care settings

are that 600,000 to 800,000 needlestick and other percutaneous

injuries occur among health care workers annually. Such

injuries can involve needles or other sharps contaminated with

bloodborne pathogens, such as HIV, HBV, or HCV.

(5) Since publication of the bloodborne pathogens standard

in 1991 there has been a substantial increase in the number

and assortment of effective engineering controls available to

employers. There is now a large body of research and data

concerning the effectiveness of newer engineering controls,

including safer medical devices.

(6) 396 interested parties responded to a Request for

Information (in this section referred to as the ‘‘RFI’’) conducted

Needlestick

Safety and

Prevention Act.

Nov. 6, 2000

[H.R. 5178]

114 STAT. 1902 PUBLIC LAW 106–430—NOV. 6, 2000

by the Occupational Safety and Health Administration in 1998

on engineering and work practice controls used to eliminate

or minimize the risk of occupational exposure to bloodborne

pathogens due to percutaneous injuries from contaminated

sharps. Comments were provided by health care facilities,

groups representing healthcare workers, researchers, educational institutions, professional and industry associations,

and manufacturers of medical devices.

(7) Numerous studies have demonstrated that the use of

safer medical devices, such as needleless systems and sharps

with engineered sharps injury protections, when they are part

of an overall bloodborne pathogens risk-reduction program, can

be extremely effective in reducing accidental sharps injuries.

(8) In March 2000, the Centers for Disease Control and

Prevention estimated that, depending on the type of device

used and the procedure involved, 62 to 88 percent of sharps

injuries can potentially be prevented by the use of safer medical

devices.

(9) The OSHA 200 Log, as it is currently maintained,

does not sufficiently reflect injuries that may involve exposure

to bloodborne pathogens in healthcare facilities. More than

98 percent of healthcare facilities responding to the RFI have

adopted surveillance systems in addition to the OSHA 200

Log. Information gathered through these surveillance systems

is commonly used for hazard identification and evaluation of

program and device effectiveness.

(10) Training and education in the use of safer medical

devices and safer work practices are significant elements in

the prevention of percutaneous exposure incidents. Staff

involvement in the device selection and evaluation process is

also an important element to achieving a reduction in sharps

injuries, particularly as new safer devices are introduced into

the work setting.

(11) Modification of the bloodborne pathogens standard

is appropriate to set forth in greater detail its requirement

that employers identify, evaluate, and make use of effective

safer medical devices.

SEC. 3. BLOODBORNE PATHOGENS STANDARD.

The bloodborne pathogens standard published at 29 CFR

1910.1030 shall be revised as follows:

(1) The definition of ‘‘Engineering Controls’’ (at 29 CFR

1910.1030(b)) shall include as additional examples of controls

the following: ‘‘safer medical devices, such as sharps with engineered sharps injury protections and needleless systems’’.

(2) The term ‘‘Sharps with Engineered Sharps Injury

Protections’’ shall be added to the definitions (at 29 CFR

1910.1030(b)) and defined 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’’.

(3) The term ‘‘Needleless Systems’’ shall be added to the

definitions (at 29 CFR 1910.1030(b)) and 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

PUBLIC LAW 106–430—NOV. 6, 2000 114 STAT. 1903

fluids; or (C) any other procedure involving the potential for

occupational exposure to bloodborne pathogens due to

percutaneous injuries from contaminated sharps’’.

(4) In addition to the existing requirements concerning

exposure control plans (29 CFR 1910.1030(c)(1)(iv)), the review

and update of such plans shall be required to 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’’.

(5) The following additional recordkeeping requirement

shall be added to the bloodborne pathogens standard at 29

CFR 1910.1030(h): ‘‘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 requirement for such sharps injury log shall not apply

to any employer who is not required to maintain a log of

occupational injuries and illnesses under 29 CFR 1904 and

the sharps injury log shall be maintained for the period required

by 29 CFR 1904.6.

(6) The following new section shall be added to the

bloodborne pathogens standard: ‘‘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.’’.

SEC. 4. EFFECT OF MODIFICATIONS.

The modifications under section 3 shall be in force until superseded in whole or in part by regulations promulgated by the Secretary of Labor under section 6(b) of the Occupational Safety and

Health Act of 1970 (29 U.S.C. 655(b)) and shall be enforced in

the same manner and to the same extent as any rule or regulation

promulgated under section 6(b).

SEC. 5. PROCEDURE AND EFFECTIVE DATE.

(a) PROCEDURE.—The modifications of the bloodborne pathogens

standard prescribed by section 3 shall take effect without regard

to the procedural requirements applicable to regulations promulgated under section 6(b) of the Occupational Safety and Health

Act of 1970 (29 U.S.C. 655(b)) or the procedural requirements

of chapter 5 of title 5, United States Code.

(b) EFFECTIVE DATE.—The modifications to the bloodborne

pathogens standard required by section 3 shall—

(1) within 6 months of the date of the enactment of this

Act, be made and published in the Federal Register by the

Deadline.

Federal Register,

publication.

Records.

114 STAT. 1904 PUBLIC LAW 106–430—NOV. 6, 2000

LEGISLATIVE HISTORY—H.R. 5178:

CONGRESSIONAL RECORD, Vol. 146 (2000):

Oct. 3, considered and passed House.

Oct. 26, considered and passed Senate.

WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 36 (2000):

Nov. 6, Presidential statement.

Æ

Secretary of Labor acting through the Occupational Safety and

Health Administration; and

(2) at the end of 90 days after such publication, take

effect.

Approved November 6, 2000.