Document ID: OSHA-2007-0080-0001
Agency: osha
Document Type: Notice
Title: Regulatory Flexibility Act Review of the Bloodborne Pathogens Standard. Request for Comments.
Posted Date: 2010-05-14T04:00Z

[Federal Register: May 14, 2010 (Volume 75, Number 93)]
[Proposed Rules]
[Page 27237-27239]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my10-20]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. OSHA-2007-0080]
RIN: 1218-AC34

Regulatory Flexibility Act Review of the Bloodborne Pathogens
Standard

AGENCY: Occupational Safety and Health Administration, Labor.

ACTION: Request for comments.

-----------------------------------------------------------------------

SUMMARY: The Occupational Safety and Health Administration (OSHA) is
conducting a review of its Bloodborne Pathogens Standard (29 CFR
1910.1030) under Section 610 of the Regulatory Flexibility Act and
Section 5 of Executive Order 12866 on Regulatory Planning and Review.
OSHA conducts its review pursuant to Section 610 of the Regulatory
Flexibility Act, 5 U.S.C. 610, and Section 5 of Executive Order (EO)
12866. Section 610 directs agencies to review impacts of regulations on
small businesses by examining: the continued need for the rule; the
nature of complaints or comments received concerning the rule from the
public; the complexity of the rule; the extent to which the rule
overlaps, duplicates or conflicts with other Federal rules, and, to the
extent feasible, with State and local governmental rules; and the
length of time since the rule has been evaluated or the degree to which
technology, economic conditions, or other factors have changed in the
area affected by the rule. The EO requires agencies to determine
whether their regulations ``should be modified or eliminated so as to
make the Agency's regulatory program more effective in achieving the
regulatory objectives, less burdensome, or in greater alignment with
the President's priorities and principles set forth in th[e] Executive
Order.'' Written comments on these and other relevant issues are
welcome.

DATES: Written comments to OSHA must be sent or postmarked by August
12, 2010.

ADDRESSES: You may submit comments by any of the following methods:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions on-line for making
electronic submissions;
    Fax: If your submissions, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648; or
    Mail, hand delivery, express mail, messenger and courier service:
You must submit three copies of your comments and attachments to the
OSHA Docket Office, Docket No. OSHA-2007-0080, U.S. Department of
Labor, Room N-2625, 200 Constitution Avenue, NW., Washington, DC 20210.
Deliveries (hand, express mail, messenger and courier service) are
accepted during the Department of Labor's and Docket Office's normal
business hours, 8:15 a.m.-4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and the
OSHA docket number for this rulemaking (OSHA-2007-0080). Submissions
are placed in the public docket without change and may be available
online http://www.regulations.gov. OSHA cautions you about submitting
personal information such as social security numbers and birth dates.
    Docket: To read or download submissions or other material in the
docket, go to http://www.regulations.gov

[[Page 27238]]

or the OSHA Docket Office at the address above. All documents in the
docket are listed in the http://www.regulations.gov index; however,
some information (e.g., copyrighted material) is not publicly available
to read or download through the Web site. All submissions, including
copyrighted material, are available for inspection and copying at the
OSHA Docket Office.

FOR FURTHER INFORMATION CONTACT: Joanna Dizikes Friedrich, Directorate
of Evaluation and Analysis, Occupational Safety and Health
Administration, Room N-3641, 200 Constitution Avenue, NW., Washington,
DC 20210, Telephone (202) 693-1939, Fax (202) 693-1641.

SUPPLEMENTARY INFORMATION:

Background

    OSHA issued the final Bloodborne Pathogens Standard (29 CFR
1910.1030) on December 6, 1991 (56 FR 64004). It was promulgated to
protect health care workers from exposure to pathogens in blood and
other potentially infectious materials, particularly the Hepatitis B
virus (HBV) and the Human Immunodeficiency Virus (HIV). Workers who may
have occupational exposure to bloodborne pathogens include, but are not
limited to, physicians, nurses, nursing home workers, dental workers,
funeral home workers, law enforcement, emergency, fire, and rescue
workers. The Standard was upheld in American Dental Assoc. v. Martin,
984 F. 2d 823 (7th Cir. 1993), cert. denied, 510 U.S. 859 (1993). The
court concluded that OSHA had shown that occupational exposure to
bloodborne pathogens constituted a significant risk and that the
compliance measures required by the standard were feasible.
    In 2001, in response to the Needlestick Safety and Prevention Act
(Pub. L. 106-430, 114 Stat. 1901), OSHA revised the Bloodborne
Pathogens Standard (66 FR 5318, 1/18/01) to include the use of safer
needle devices and to involve employees in identifying and choosing
these devices. Also, the updated Standard requires employers to
maintain a log of injuries from contaminated sharps.\1\ (A sharp is any
object that can penetrate the skin including, but not limited to,
needles, scalpels, broken glass, broken capillary tubes, and exposed
ends of dental wires.) Significant requirements of the 1991 Standard
are as follows: \2\
---------------------------------------------------------------------------

    \1\ http://www.osha.gov/SLTC/bloodbornepathogens/index.html.
    \2\ United States Department of Health and Human Services;
Centers for Disease Control and Prevention (CDC); National Institute
for Occupational Safety and Health (NIOSH); ``NIOSH Alert:
Preventing Needlestick Injuries in Health Care Settings;'' NIOSH
Publication No. 2000-108; November 1999.
---------------------------------------------------------------------------

     A written exposure plan intended to minimize or eliminate
workers' exposures to bloodborne pathogens;
     Use of Universal Precautions (i.e., an infection control
approach in which all human blood and certain human body fluids are
treated as if known to be infectious for HIV, HBV, and other bloodborne
pathogens);
     Engineering controls to minimize or eliminate worker
exposure;
     Work practices to minimize or eliminate worker exposure;
     Personal protective equipment if worker exposure is not
eliminated by engineering controls or work practices;
     Unless required by a specific medical or dental procedure
or there is no feasible alternative, bending, recapping, or removing
contaminated needles and other sharps is prohibited;
     Shearing or breaking contaminated needles (i.e., needles
reasonably expected to have blood or other potentially infectious
substances on them) is prohibited;
     Employers must make HBV vaccinations available to
employees occupationally exposed to bloodborne pathogens and at no cost
to the employees;
     Employee training;
     Post-exposure evaluation and follow-up;
     If appropriate, post-exposure prophylaxis.
    The revised 2001 Standard clarifies the need for employers to: \3\
---------------------------------------------------------------------------

    \3\ United States Department of Labor, Occupational Safety and
Health Administration (OSHA); Safety and Health Topics, Bloodborne
Pathogens and Needlestick Prevention; http://www.osha.gov/SLTC/
bloodbornepathogens/index.html.
---------------------------------------------------------------------------

     Select safer needle devices;
     Involve employees in identifying and choosing safer needle
devices;
     Maintain a log of injuries from contaminated sharps.
    In conducting this lookback review, OSHA intends to investigate
possible sources of occupational data on HIV, HBV, and needlestick
injuries that may be applied to analyzing the impact of the Standard.
Medical developments and treatment protocols may also be reviewed.
Since the Standard affects small businesses across a range of sectors,
the lookback review might identify opportunities for reducing the
burden on small entities while maintaining or improving worker
protection, particularly outside the healthcare sectors.

Regulatory Review

    OSHA is reviewing the Bloodborne Pathogens Standard (29 CFR
1910.1030) under Section 610 of the Regulatory Flexibility Act (5
U.S.C. 601 et seq.) and Section 5 of Executive Order 12866 (58 FR
51735, Oct 4, 1993).
    The purpose of a review under Section 610 of the Regulatory
Flexibility Act:

``[S]hall be to determine whether such rules should be continued
without change, or should be amended or rescinded, consistent with the
stated objectives of applicable statutes, to minimize any significant
impact of the rules upon a substantial number of such small entities.''
    In reviewing rules under this Section, ``the agency shall consider
the following factors:
    (1) The continued need for the rule;
    (2) The nature of complaints or comments received concerning the
rule from the public;
    (3) The complexity of the rule;
    (4) The extent to which the rule overlaps, duplicates or conflicts
with other Federal rules, and, to the extent feasible, with State and
local governmental rules; and
    (5) The length of time since the rule has been evaluated or the
degree to which technology, economic conditions, or other factors have
changed in the area affected by the rule.''
    The review requirements of Section 5 of Executive Order 12866
require agencies:

``* * * to reduce the regulatory burden on the American people, their
families, their communities, their State, local, and Tribal
governments, and their industries; to determine whether regulations
promulgated by the * * * [Agency] have become unjustified or
unnecessary as a result of changed circumstances; to confirm that
regulations are both compatible with each other and not duplicative or
inappropriately burdensome in the aggregate; to ensure that all
regulations are consistent with the President's priorities and the
principles set forth in this Executive order, within applicable law;
and to otherwise improve the effectiveness of existing regulations * *
*.''

Request for Comments

    An important step in the review process involves gathering and
analyzing information from affected persons about their experience
complying with the rule and any material changes in circumstances since
the rule was issued. This notice requests written comments on the
continuing

[[Page 27239]]

need for the Bloodborne Pathogens Standard (29 CFR 1910.1030), its
impact on small businesses, its effectiveness in protecting workers,
and all other issues raised by Section 610 of the Regulatory
Flexibility Act and Section 5 of Executive Order 12866. It would be
particularly helpful for commenters to suggest how the Standard could
be modified to reduce the burden on employers while maintaining or
improving employee protection. Furthermore, comments would be
appreciated on the following topics:
     Exposures in non-hospital settings;
     Recent technological advances in needlestick prevention;
     Effectiveness of needlestick prevention programs;
     New, emerging health risks from bloodborne pathogens; and
     Any other experiences related to compliance with the
standard.

Public comments will assist the Agency in determining whether to retain
the Standard unchanged, to initiate rulemaking to revise or rescind it,
or to develop improved compliance assistance.
    Comments must be submitted by August 12, 2010. Comments should be
submitted to the addresses and in the manner specified at the beginning
of the notice.

    Authority: This document was prepared under the direction of
David Michaels, PhD, MPH, Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue, NW.,
Washington, DC 20210. It is issued under Section 610 of the
Regulatory Flexibility Act (5 U.S.C. 610) and Section 5 of Executive
Order 12866 (58 FR 51735, October 4, 1993).

    Signed at Washington, DC on May 11, 2010.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2010-11579 Filed 5-13-10; 8:45 am]
BILLING CODE 4510-29-P