2010-11579. 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 [phone]; 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 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 [phone], Fax [phone].

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]

• 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]

• 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 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.

Footnotes

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.

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.