Regulatory Flexibility Act Review of the Bloodborne Pathogens Standard, 27237-27239 [2010-11579]

Agencies

• DEPARTMENT OF LABOR
• Occupational Safety and Health Administration

[Federal Register Volume 75, Number 93 (Friday, May 14, 2010)]
[Proposed Rules]
[Pages 27237-27239]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11579]


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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.

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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 https://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 https://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 https://www.regulations.gov

[[Page 27238]]

or the OSHA Docket Office at the address above. All documents in the 
docket are listed in the https://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\
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    \1\ https://www.osha.gov/SLTC/bloodbornepathogens/.
    \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.
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     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\
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    \3\ United States Department of Labor, Occupational Safety and 
Health Administration (OSHA); Safety and Health Topics, Bloodborne 
Pathogens and Needlestick Prevention; https://www.osha.gov/SLTC/bloodbornepathogens/.
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     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]
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